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OBSTETRIC DRILLS ndashPPHINDIA AUG 2016 6-11TH
HYDERABADCHENNAIMUMBAIKOLKATADELHI amp
LUCKNOW
IAN DONALD SCHOOL OF ULTRASOUNDamp
LUPIN6 DAYS 6 CITIES HANDS ON TRAINING
CONDUCTED BYbull ROBIN BURR(AUSTRALIA)bull SULLEN MILLER(USA)bull NARENDRA MALHOTRAbull SHEELA MANEbull JAIDEEP MALHOTRAbull ALKA KRIPLANIbull SADHNA GUPTAJAYAM KANANASHISH MUKERJEEVP PAILEYAPARNA SHARMASEEMA AMBUJA C
WELCOME
copy Suellen Miller 2016
OBSTETRIC DRILLSTHE PPH DRILL
PPH Drill
Jaideep MalhotraNarendra MalhotraNeharika MalhotraRAINBOW HOSPITALSwwwmalhotrahospitalscomwwwrainbowhospitalsorg
PPHDr Robin Burr
Worldwide issueOver 300000 women and 27 million newborn babies die each year in pregnancy and childbirth or soon afterwards the majority of them in Africa and South Asia
Every minute of every day somewhere in the world a woman dies from complications related to pregnancy or childbirth
99 of maternal deaths occur in the developing worldwwwwomenandchildrenfirstorguk
Postpartum haemorrhage 1500 ml or more - all women who give birth vaginally
httpswomenwchaasnau
MDG - GOAL 5 IMPROVE MATERNAL HEALTH
- Maternal mortality ratio (per 100000 live births)
InitialValue
LastValue
2015Target
Achievingtarget in
5600 1900 1400 2021
Achieving Millennium Development Goal 5 is India seriousDileep Mavalankar Kranti Vora M PrakasammaIndia - largest number of births per year (27 million) in the world Maternal mortality of about 300ndash500 per 100 000 births about 75 000 to 150 000 maternal deaths occur every year in Indiabull Absence of focus on emergency obstetric carebull Missing midwivesbull Lack of management capacity in the health systembull No political willbull Absence of comprehensive maternal care services
Bulletin of the World Health OrganizationgtPast issuesgtVolume 86 2008gtVolume 86 Number 4 April 2008 241-320
MMR India over time
Year MMR1990 5561995 4712000 3742005 2802010 2152015 174
Source WHO UNICEF UNFPA World Bank Group and UNPD (MMEIG) - November 2015
Maternal Mortality
DefinitionsPrimary PPH
gt 500 ml (spontaneous delivery)gt 1000 ml (caesarean section)
Severe haemorrhage blood loss gt 150 mlmin (within 20 min causing loss of more
than 50 of blood volume)sudden blood loss gt 1500-2000 ml (uterine atony loss of 25-
35 of blood volume)
Causes of PPH the 4 TrsquosTone uterine atony distended bladder
Trauma uterine cervical or vaginal injury
Tissue retained placenta or clots
Thrombin pre-existing or acquired coagulopathy
Antenatal risk factorsbull Polyhydramnios bull Multiple pregnancy bull Fibroids bull Past PPH bull Previous retained placenta bull Previous Caesarean Section uterine
surgery bull Placenta praeviapercreta increta bull APH
bull High parity bull Maternal Age bull Obesity bull Drugs eg NifedipineMgSO4
salbutamol bull Hypertensive disorders bull Pre-existing coagulation disorder
eg Von Willebrandrsquos bull Therapeutic anticoagulation bull Anaemia
Intrapartum risks
bull Fetal demise in utero bull Abruption bull Inductionaugmentation of
labour bull Prolonged labour bull Pyrexia bull Prolonged ruptured
membranes
bull Instrumental delivery bull Episiotomy bull Retained
placentamembranes bull Physiological third stage bull Drugs eg inhaled
anaesthetic agents bull Therapeutic anticoagulation
DIC
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
CONDUCTED BYbull ROBIN BURR(AUSTRALIA)bull SULLEN MILLER(USA)bull NARENDRA MALHOTRAbull SHEELA MANEbull JAIDEEP MALHOTRAbull ALKA KRIPLANIbull SADHNA GUPTAJAYAM KANANASHISH MUKERJEEVP PAILEYAPARNA SHARMASEEMA AMBUJA C
WELCOME
copy Suellen Miller 2016
OBSTETRIC DRILLSTHE PPH DRILL
PPH Drill
Jaideep MalhotraNarendra MalhotraNeharika MalhotraRAINBOW HOSPITALSwwwmalhotrahospitalscomwwwrainbowhospitalsorg
PPHDr Robin Burr
Worldwide issueOver 300000 women and 27 million newborn babies die each year in pregnancy and childbirth or soon afterwards the majority of them in Africa and South Asia
Every minute of every day somewhere in the world a woman dies from complications related to pregnancy or childbirth
99 of maternal deaths occur in the developing worldwwwwomenandchildrenfirstorguk
Postpartum haemorrhage 1500 ml or more - all women who give birth vaginally
httpswomenwchaasnau
MDG - GOAL 5 IMPROVE MATERNAL HEALTH
- Maternal mortality ratio (per 100000 live births)
InitialValue
LastValue
2015Target
Achievingtarget in
5600 1900 1400 2021
Achieving Millennium Development Goal 5 is India seriousDileep Mavalankar Kranti Vora M PrakasammaIndia - largest number of births per year (27 million) in the world Maternal mortality of about 300ndash500 per 100 000 births about 75 000 to 150 000 maternal deaths occur every year in Indiabull Absence of focus on emergency obstetric carebull Missing midwivesbull Lack of management capacity in the health systembull No political willbull Absence of comprehensive maternal care services
Bulletin of the World Health OrganizationgtPast issuesgtVolume 86 2008gtVolume 86 Number 4 April 2008 241-320
MMR India over time
Year MMR1990 5561995 4712000 3742005 2802010 2152015 174
Source WHO UNICEF UNFPA World Bank Group and UNPD (MMEIG) - November 2015
Maternal Mortality
DefinitionsPrimary PPH
gt 500 ml (spontaneous delivery)gt 1000 ml (caesarean section)
Severe haemorrhage blood loss gt 150 mlmin (within 20 min causing loss of more
than 50 of blood volume)sudden blood loss gt 1500-2000 ml (uterine atony loss of 25-
35 of blood volume)
Causes of PPH the 4 TrsquosTone uterine atony distended bladder
Trauma uterine cervical or vaginal injury
Tissue retained placenta or clots
Thrombin pre-existing or acquired coagulopathy
Antenatal risk factorsbull Polyhydramnios bull Multiple pregnancy bull Fibroids bull Past PPH bull Previous retained placenta bull Previous Caesarean Section uterine
surgery bull Placenta praeviapercreta increta bull APH
bull High parity bull Maternal Age bull Obesity bull Drugs eg NifedipineMgSO4
salbutamol bull Hypertensive disorders bull Pre-existing coagulation disorder
eg Von Willebrandrsquos bull Therapeutic anticoagulation bull Anaemia
Intrapartum risks
bull Fetal demise in utero bull Abruption bull Inductionaugmentation of
labour bull Prolonged labour bull Pyrexia bull Prolonged ruptured
membranes
bull Instrumental delivery bull Episiotomy bull Retained
placentamembranes bull Physiological third stage bull Drugs eg inhaled
anaesthetic agents bull Therapeutic anticoagulation
DIC
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
WELCOME
copy Suellen Miller 2016
OBSTETRIC DRILLSTHE PPH DRILL
PPH Drill
Jaideep MalhotraNarendra MalhotraNeharika MalhotraRAINBOW HOSPITALSwwwmalhotrahospitalscomwwwrainbowhospitalsorg
PPHDr Robin Burr
Worldwide issueOver 300000 women and 27 million newborn babies die each year in pregnancy and childbirth or soon afterwards the majority of them in Africa and South Asia
Every minute of every day somewhere in the world a woman dies from complications related to pregnancy or childbirth
99 of maternal deaths occur in the developing worldwwwwomenandchildrenfirstorguk
Postpartum haemorrhage 1500 ml or more - all women who give birth vaginally
httpswomenwchaasnau
MDG - GOAL 5 IMPROVE MATERNAL HEALTH
- Maternal mortality ratio (per 100000 live births)
InitialValue
LastValue
2015Target
Achievingtarget in
5600 1900 1400 2021
Achieving Millennium Development Goal 5 is India seriousDileep Mavalankar Kranti Vora M PrakasammaIndia - largest number of births per year (27 million) in the world Maternal mortality of about 300ndash500 per 100 000 births about 75 000 to 150 000 maternal deaths occur every year in Indiabull Absence of focus on emergency obstetric carebull Missing midwivesbull Lack of management capacity in the health systembull No political willbull Absence of comprehensive maternal care services
Bulletin of the World Health OrganizationgtPast issuesgtVolume 86 2008gtVolume 86 Number 4 April 2008 241-320
MMR India over time
Year MMR1990 5561995 4712000 3742005 2802010 2152015 174
Source WHO UNICEF UNFPA World Bank Group and UNPD (MMEIG) - November 2015
Maternal Mortality
DefinitionsPrimary PPH
gt 500 ml (spontaneous delivery)gt 1000 ml (caesarean section)
Severe haemorrhage blood loss gt 150 mlmin (within 20 min causing loss of more
than 50 of blood volume)sudden blood loss gt 1500-2000 ml (uterine atony loss of 25-
35 of blood volume)
Causes of PPH the 4 TrsquosTone uterine atony distended bladder
Trauma uterine cervical or vaginal injury
Tissue retained placenta or clots
Thrombin pre-existing or acquired coagulopathy
Antenatal risk factorsbull Polyhydramnios bull Multiple pregnancy bull Fibroids bull Past PPH bull Previous retained placenta bull Previous Caesarean Section uterine
surgery bull Placenta praeviapercreta increta bull APH
bull High parity bull Maternal Age bull Obesity bull Drugs eg NifedipineMgSO4
salbutamol bull Hypertensive disorders bull Pre-existing coagulation disorder
eg Von Willebrandrsquos bull Therapeutic anticoagulation bull Anaemia
Intrapartum risks
bull Fetal demise in utero bull Abruption bull Inductionaugmentation of
labour bull Prolonged labour bull Pyrexia bull Prolonged ruptured
membranes
bull Instrumental delivery bull Episiotomy bull Retained
placentamembranes bull Physiological third stage bull Drugs eg inhaled
anaesthetic agents bull Therapeutic anticoagulation
DIC
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
copy Suellen Miller 2016
OBSTETRIC DRILLSTHE PPH DRILL
PPH Drill
Jaideep MalhotraNarendra MalhotraNeharika MalhotraRAINBOW HOSPITALSwwwmalhotrahospitalscomwwwrainbowhospitalsorg
PPHDr Robin Burr
Worldwide issueOver 300000 women and 27 million newborn babies die each year in pregnancy and childbirth or soon afterwards the majority of them in Africa and South Asia
Every minute of every day somewhere in the world a woman dies from complications related to pregnancy or childbirth
99 of maternal deaths occur in the developing worldwwwwomenandchildrenfirstorguk
Postpartum haemorrhage 1500 ml or more - all women who give birth vaginally
httpswomenwchaasnau
MDG - GOAL 5 IMPROVE MATERNAL HEALTH
- Maternal mortality ratio (per 100000 live births)
InitialValue
LastValue
2015Target
Achievingtarget in
5600 1900 1400 2021
Achieving Millennium Development Goal 5 is India seriousDileep Mavalankar Kranti Vora M PrakasammaIndia - largest number of births per year (27 million) in the world Maternal mortality of about 300ndash500 per 100 000 births about 75 000 to 150 000 maternal deaths occur every year in Indiabull Absence of focus on emergency obstetric carebull Missing midwivesbull Lack of management capacity in the health systembull No political willbull Absence of comprehensive maternal care services
Bulletin of the World Health OrganizationgtPast issuesgtVolume 86 2008gtVolume 86 Number 4 April 2008 241-320
MMR India over time
Year MMR1990 5561995 4712000 3742005 2802010 2152015 174
Source WHO UNICEF UNFPA World Bank Group and UNPD (MMEIG) - November 2015
Maternal Mortality
DefinitionsPrimary PPH
gt 500 ml (spontaneous delivery)gt 1000 ml (caesarean section)
Severe haemorrhage blood loss gt 150 mlmin (within 20 min causing loss of more
than 50 of blood volume)sudden blood loss gt 1500-2000 ml (uterine atony loss of 25-
35 of blood volume)
Causes of PPH the 4 TrsquosTone uterine atony distended bladder
Trauma uterine cervical or vaginal injury
Tissue retained placenta or clots
Thrombin pre-existing or acquired coagulopathy
Antenatal risk factorsbull Polyhydramnios bull Multiple pregnancy bull Fibroids bull Past PPH bull Previous retained placenta bull Previous Caesarean Section uterine
surgery bull Placenta praeviapercreta increta bull APH
bull High parity bull Maternal Age bull Obesity bull Drugs eg NifedipineMgSO4
salbutamol bull Hypertensive disorders bull Pre-existing coagulation disorder
eg Von Willebrandrsquos bull Therapeutic anticoagulation bull Anaemia
Intrapartum risks
bull Fetal demise in utero bull Abruption bull Inductionaugmentation of
labour bull Prolonged labour bull Pyrexia bull Prolonged ruptured
membranes
bull Instrumental delivery bull Episiotomy bull Retained
placentamembranes bull Physiological third stage bull Drugs eg inhaled
anaesthetic agents bull Therapeutic anticoagulation
DIC
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
PPH Drill
Jaideep MalhotraNarendra MalhotraNeharika MalhotraRAINBOW HOSPITALSwwwmalhotrahospitalscomwwwrainbowhospitalsorg
PPHDr Robin Burr
Worldwide issueOver 300000 women and 27 million newborn babies die each year in pregnancy and childbirth or soon afterwards the majority of them in Africa and South Asia
Every minute of every day somewhere in the world a woman dies from complications related to pregnancy or childbirth
99 of maternal deaths occur in the developing worldwwwwomenandchildrenfirstorguk
Postpartum haemorrhage 1500 ml or more - all women who give birth vaginally
httpswomenwchaasnau
MDG - GOAL 5 IMPROVE MATERNAL HEALTH
- Maternal mortality ratio (per 100000 live births)
InitialValue
LastValue
2015Target
Achievingtarget in
5600 1900 1400 2021
Achieving Millennium Development Goal 5 is India seriousDileep Mavalankar Kranti Vora M PrakasammaIndia - largest number of births per year (27 million) in the world Maternal mortality of about 300ndash500 per 100 000 births about 75 000 to 150 000 maternal deaths occur every year in Indiabull Absence of focus on emergency obstetric carebull Missing midwivesbull Lack of management capacity in the health systembull No political willbull Absence of comprehensive maternal care services
Bulletin of the World Health OrganizationgtPast issuesgtVolume 86 2008gtVolume 86 Number 4 April 2008 241-320
MMR India over time
Year MMR1990 5561995 4712000 3742005 2802010 2152015 174
Source WHO UNICEF UNFPA World Bank Group and UNPD (MMEIG) - November 2015
Maternal Mortality
DefinitionsPrimary PPH
gt 500 ml (spontaneous delivery)gt 1000 ml (caesarean section)
Severe haemorrhage blood loss gt 150 mlmin (within 20 min causing loss of more
than 50 of blood volume)sudden blood loss gt 1500-2000 ml (uterine atony loss of 25-
35 of blood volume)
Causes of PPH the 4 TrsquosTone uterine atony distended bladder
Trauma uterine cervical or vaginal injury
Tissue retained placenta or clots
Thrombin pre-existing or acquired coagulopathy
Antenatal risk factorsbull Polyhydramnios bull Multiple pregnancy bull Fibroids bull Past PPH bull Previous retained placenta bull Previous Caesarean Section uterine
surgery bull Placenta praeviapercreta increta bull APH
bull High parity bull Maternal Age bull Obesity bull Drugs eg NifedipineMgSO4
salbutamol bull Hypertensive disorders bull Pre-existing coagulation disorder
eg Von Willebrandrsquos bull Therapeutic anticoagulation bull Anaemia
Intrapartum risks
bull Fetal demise in utero bull Abruption bull Inductionaugmentation of
labour bull Prolonged labour bull Pyrexia bull Prolonged ruptured
membranes
bull Instrumental delivery bull Episiotomy bull Retained
placentamembranes bull Physiological third stage bull Drugs eg inhaled
anaesthetic agents bull Therapeutic anticoagulation
DIC
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
PPHDr Robin Burr
Worldwide issueOver 300000 women and 27 million newborn babies die each year in pregnancy and childbirth or soon afterwards the majority of them in Africa and South Asia
Every minute of every day somewhere in the world a woman dies from complications related to pregnancy or childbirth
99 of maternal deaths occur in the developing worldwwwwomenandchildrenfirstorguk
Postpartum haemorrhage 1500 ml or more - all women who give birth vaginally
httpswomenwchaasnau
MDG - GOAL 5 IMPROVE MATERNAL HEALTH
- Maternal mortality ratio (per 100000 live births)
InitialValue
LastValue
2015Target
Achievingtarget in
5600 1900 1400 2021
Achieving Millennium Development Goal 5 is India seriousDileep Mavalankar Kranti Vora M PrakasammaIndia - largest number of births per year (27 million) in the world Maternal mortality of about 300ndash500 per 100 000 births about 75 000 to 150 000 maternal deaths occur every year in Indiabull Absence of focus on emergency obstetric carebull Missing midwivesbull Lack of management capacity in the health systembull No political willbull Absence of comprehensive maternal care services
Bulletin of the World Health OrganizationgtPast issuesgtVolume 86 2008gtVolume 86 Number 4 April 2008 241-320
MMR India over time
Year MMR1990 5561995 4712000 3742005 2802010 2152015 174
Source WHO UNICEF UNFPA World Bank Group and UNPD (MMEIG) - November 2015
Maternal Mortality
DefinitionsPrimary PPH
gt 500 ml (spontaneous delivery)gt 1000 ml (caesarean section)
Severe haemorrhage blood loss gt 150 mlmin (within 20 min causing loss of more
than 50 of blood volume)sudden blood loss gt 1500-2000 ml (uterine atony loss of 25-
35 of blood volume)
Causes of PPH the 4 TrsquosTone uterine atony distended bladder
Trauma uterine cervical or vaginal injury
Tissue retained placenta or clots
Thrombin pre-existing or acquired coagulopathy
Antenatal risk factorsbull Polyhydramnios bull Multiple pregnancy bull Fibroids bull Past PPH bull Previous retained placenta bull Previous Caesarean Section uterine
surgery bull Placenta praeviapercreta increta bull APH
bull High parity bull Maternal Age bull Obesity bull Drugs eg NifedipineMgSO4
salbutamol bull Hypertensive disorders bull Pre-existing coagulation disorder
eg Von Willebrandrsquos bull Therapeutic anticoagulation bull Anaemia
Intrapartum risks
bull Fetal demise in utero bull Abruption bull Inductionaugmentation of
labour bull Prolonged labour bull Pyrexia bull Prolonged ruptured
membranes
bull Instrumental delivery bull Episiotomy bull Retained
placentamembranes bull Physiological third stage bull Drugs eg inhaled
anaesthetic agents bull Therapeutic anticoagulation
DIC
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Worldwide issueOver 300000 women and 27 million newborn babies die each year in pregnancy and childbirth or soon afterwards the majority of them in Africa and South Asia
Every minute of every day somewhere in the world a woman dies from complications related to pregnancy or childbirth
99 of maternal deaths occur in the developing worldwwwwomenandchildrenfirstorguk
Postpartum haemorrhage 1500 ml or more - all women who give birth vaginally
httpswomenwchaasnau
MDG - GOAL 5 IMPROVE MATERNAL HEALTH
- Maternal mortality ratio (per 100000 live births)
InitialValue
LastValue
2015Target
Achievingtarget in
5600 1900 1400 2021
Achieving Millennium Development Goal 5 is India seriousDileep Mavalankar Kranti Vora M PrakasammaIndia - largest number of births per year (27 million) in the world Maternal mortality of about 300ndash500 per 100 000 births about 75 000 to 150 000 maternal deaths occur every year in Indiabull Absence of focus on emergency obstetric carebull Missing midwivesbull Lack of management capacity in the health systembull No political willbull Absence of comprehensive maternal care services
Bulletin of the World Health OrganizationgtPast issuesgtVolume 86 2008gtVolume 86 Number 4 April 2008 241-320
MMR India over time
Year MMR1990 5561995 4712000 3742005 2802010 2152015 174
Source WHO UNICEF UNFPA World Bank Group and UNPD (MMEIG) - November 2015
Maternal Mortality
DefinitionsPrimary PPH
gt 500 ml (spontaneous delivery)gt 1000 ml (caesarean section)
Severe haemorrhage blood loss gt 150 mlmin (within 20 min causing loss of more
than 50 of blood volume)sudden blood loss gt 1500-2000 ml (uterine atony loss of 25-
35 of blood volume)
Causes of PPH the 4 TrsquosTone uterine atony distended bladder
Trauma uterine cervical or vaginal injury
Tissue retained placenta or clots
Thrombin pre-existing or acquired coagulopathy
Antenatal risk factorsbull Polyhydramnios bull Multiple pregnancy bull Fibroids bull Past PPH bull Previous retained placenta bull Previous Caesarean Section uterine
surgery bull Placenta praeviapercreta increta bull APH
bull High parity bull Maternal Age bull Obesity bull Drugs eg NifedipineMgSO4
salbutamol bull Hypertensive disorders bull Pre-existing coagulation disorder
eg Von Willebrandrsquos bull Therapeutic anticoagulation bull Anaemia
Intrapartum risks
bull Fetal demise in utero bull Abruption bull Inductionaugmentation of
labour bull Prolonged labour bull Pyrexia bull Prolonged ruptured
membranes
bull Instrumental delivery bull Episiotomy bull Retained
placentamembranes bull Physiological third stage bull Drugs eg inhaled
anaesthetic agents bull Therapeutic anticoagulation
DIC
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Postpartum haemorrhage 1500 ml or more - all women who give birth vaginally
httpswomenwchaasnau
MDG - GOAL 5 IMPROVE MATERNAL HEALTH
- Maternal mortality ratio (per 100000 live births)
InitialValue
LastValue
2015Target
Achievingtarget in
5600 1900 1400 2021
Achieving Millennium Development Goal 5 is India seriousDileep Mavalankar Kranti Vora M PrakasammaIndia - largest number of births per year (27 million) in the world Maternal mortality of about 300ndash500 per 100 000 births about 75 000 to 150 000 maternal deaths occur every year in Indiabull Absence of focus on emergency obstetric carebull Missing midwivesbull Lack of management capacity in the health systembull No political willbull Absence of comprehensive maternal care services
Bulletin of the World Health OrganizationgtPast issuesgtVolume 86 2008gtVolume 86 Number 4 April 2008 241-320
MMR India over time
Year MMR1990 5561995 4712000 3742005 2802010 2152015 174
Source WHO UNICEF UNFPA World Bank Group and UNPD (MMEIG) - November 2015
Maternal Mortality
DefinitionsPrimary PPH
gt 500 ml (spontaneous delivery)gt 1000 ml (caesarean section)
Severe haemorrhage blood loss gt 150 mlmin (within 20 min causing loss of more
than 50 of blood volume)sudden blood loss gt 1500-2000 ml (uterine atony loss of 25-
35 of blood volume)
Causes of PPH the 4 TrsquosTone uterine atony distended bladder
Trauma uterine cervical or vaginal injury
Tissue retained placenta or clots
Thrombin pre-existing or acquired coagulopathy
Antenatal risk factorsbull Polyhydramnios bull Multiple pregnancy bull Fibroids bull Past PPH bull Previous retained placenta bull Previous Caesarean Section uterine
surgery bull Placenta praeviapercreta increta bull APH
bull High parity bull Maternal Age bull Obesity bull Drugs eg NifedipineMgSO4
salbutamol bull Hypertensive disorders bull Pre-existing coagulation disorder
eg Von Willebrandrsquos bull Therapeutic anticoagulation bull Anaemia
Intrapartum risks
bull Fetal demise in utero bull Abruption bull Inductionaugmentation of
labour bull Prolonged labour bull Pyrexia bull Prolonged ruptured
membranes
bull Instrumental delivery bull Episiotomy bull Retained
placentamembranes bull Physiological third stage bull Drugs eg inhaled
anaesthetic agents bull Therapeutic anticoagulation
DIC
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
MDG - GOAL 5 IMPROVE MATERNAL HEALTH
- Maternal mortality ratio (per 100000 live births)
InitialValue
LastValue
2015Target
Achievingtarget in
5600 1900 1400 2021
Achieving Millennium Development Goal 5 is India seriousDileep Mavalankar Kranti Vora M PrakasammaIndia - largest number of births per year (27 million) in the world Maternal mortality of about 300ndash500 per 100 000 births about 75 000 to 150 000 maternal deaths occur every year in Indiabull Absence of focus on emergency obstetric carebull Missing midwivesbull Lack of management capacity in the health systembull No political willbull Absence of comprehensive maternal care services
Bulletin of the World Health OrganizationgtPast issuesgtVolume 86 2008gtVolume 86 Number 4 April 2008 241-320
MMR India over time
Year MMR1990 5561995 4712000 3742005 2802010 2152015 174
Source WHO UNICEF UNFPA World Bank Group and UNPD (MMEIG) - November 2015
Maternal Mortality
DefinitionsPrimary PPH
gt 500 ml (spontaneous delivery)gt 1000 ml (caesarean section)
Severe haemorrhage blood loss gt 150 mlmin (within 20 min causing loss of more
than 50 of blood volume)sudden blood loss gt 1500-2000 ml (uterine atony loss of 25-
35 of blood volume)
Causes of PPH the 4 TrsquosTone uterine atony distended bladder
Trauma uterine cervical or vaginal injury
Tissue retained placenta or clots
Thrombin pre-existing or acquired coagulopathy
Antenatal risk factorsbull Polyhydramnios bull Multiple pregnancy bull Fibroids bull Past PPH bull Previous retained placenta bull Previous Caesarean Section uterine
surgery bull Placenta praeviapercreta increta bull APH
bull High parity bull Maternal Age bull Obesity bull Drugs eg NifedipineMgSO4
salbutamol bull Hypertensive disorders bull Pre-existing coagulation disorder
eg Von Willebrandrsquos bull Therapeutic anticoagulation bull Anaemia
Intrapartum risks
bull Fetal demise in utero bull Abruption bull Inductionaugmentation of
labour bull Prolonged labour bull Pyrexia bull Prolonged ruptured
membranes
bull Instrumental delivery bull Episiotomy bull Retained
placentamembranes bull Physiological third stage bull Drugs eg inhaled
anaesthetic agents bull Therapeutic anticoagulation
DIC
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
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Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
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Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
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Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
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Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
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The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
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TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Achieving Millennium Development Goal 5 is India seriousDileep Mavalankar Kranti Vora M PrakasammaIndia - largest number of births per year (27 million) in the world Maternal mortality of about 300ndash500 per 100 000 births about 75 000 to 150 000 maternal deaths occur every year in Indiabull Absence of focus on emergency obstetric carebull Missing midwivesbull Lack of management capacity in the health systembull No political willbull Absence of comprehensive maternal care services
Bulletin of the World Health OrganizationgtPast issuesgtVolume 86 2008gtVolume 86 Number 4 April 2008 241-320
MMR India over time
Year MMR1990 5561995 4712000 3742005 2802010 2152015 174
Source WHO UNICEF UNFPA World Bank Group and UNPD (MMEIG) - November 2015
Maternal Mortality
DefinitionsPrimary PPH
gt 500 ml (spontaneous delivery)gt 1000 ml (caesarean section)
Severe haemorrhage blood loss gt 150 mlmin (within 20 min causing loss of more
than 50 of blood volume)sudden blood loss gt 1500-2000 ml (uterine atony loss of 25-
35 of blood volume)
Causes of PPH the 4 TrsquosTone uterine atony distended bladder
Trauma uterine cervical or vaginal injury
Tissue retained placenta or clots
Thrombin pre-existing or acquired coagulopathy
Antenatal risk factorsbull Polyhydramnios bull Multiple pregnancy bull Fibroids bull Past PPH bull Previous retained placenta bull Previous Caesarean Section uterine
surgery bull Placenta praeviapercreta increta bull APH
bull High parity bull Maternal Age bull Obesity bull Drugs eg NifedipineMgSO4
salbutamol bull Hypertensive disorders bull Pre-existing coagulation disorder
eg Von Willebrandrsquos bull Therapeutic anticoagulation bull Anaemia
Intrapartum risks
bull Fetal demise in utero bull Abruption bull Inductionaugmentation of
labour bull Prolonged labour bull Pyrexia bull Prolonged ruptured
membranes
bull Instrumental delivery bull Episiotomy bull Retained
placentamembranes bull Physiological third stage bull Drugs eg inhaled
anaesthetic agents bull Therapeutic anticoagulation
DIC
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
MMR India over time
Year MMR1990 5561995 4712000 3742005 2802010 2152015 174
Source WHO UNICEF UNFPA World Bank Group and UNPD (MMEIG) - November 2015
Maternal Mortality
DefinitionsPrimary PPH
gt 500 ml (spontaneous delivery)gt 1000 ml (caesarean section)
Severe haemorrhage blood loss gt 150 mlmin (within 20 min causing loss of more
than 50 of blood volume)sudden blood loss gt 1500-2000 ml (uterine atony loss of 25-
35 of blood volume)
Causes of PPH the 4 TrsquosTone uterine atony distended bladder
Trauma uterine cervical or vaginal injury
Tissue retained placenta or clots
Thrombin pre-existing or acquired coagulopathy
Antenatal risk factorsbull Polyhydramnios bull Multiple pregnancy bull Fibroids bull Past PPH bull Previous retained placenta bull Previous Caesarean Section uterine
surgery bull Placenta praeviapercreta increta bull APH
bull High parity bull Maternal Age bull Obesity bull Drugs eg NifedipineMgSO4
salbutamol bull Hypertensive disorders bull Pre-existing coagulation disorder
eg Von Willebrandrsquos bull Therapeutic anticoagulation bull Anaemia
Intrapartum risks
bull Fetal demise in utero bull Abruption bull Inductionaugmentation of
labour bull Prolonged labour bull Pyrexia bull Prolonged ruptured
membranes
bull Instrumental delivery bull Episiotomy bull Retained
placentamembranes bull Physiological third stage bull Drugs eg inhaled
anaesthetic agents bull Therapeutic anticoagulation
DIC
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Maternal Mortality
DefinitionsPrimary PPH
gt 500 ml (spontaneous delivery)gt 1000 ml (caesarean section)
Severe haemorrhage blood loss gt 150 mlmin (within 20 min causing loss of more
than 50 of blood volume)sudden blood loss gt 1500-2000 ml (uterine atony loss of 25-
35 of blood volume)
Causes of PPH the 4 TrsquosTone uterine atony distended bladder
Trauma uterine cervical or vaginal injury
Tissue retained placenta or clots
Thrombin pre-existing or acquired coagulopathy
Antenatal risk factorsbull Polyhydramnios bull Multiple pregnancy bull Fibroids bull Past PPH bull Previous retained placenta bull Previous Caesarean Section uterine
surgery bull Placenta praeviapercreta increta bull APH
bull High parity bull Maternal Age bull Obesity bull Drugs eg NifedipineMgSO4
salbutamol bull Hypertensive disorders bull Pre-existing coagulation disorder
eg Von Willebrandrsquos bull Therapeutic anticoagulation bull Anaemia
Intrapartum risks
bull Fetal demise in utero bull Abruption bull Inductionaugmentation of
labour bull Prolonged labour bull Pyrexia bull Prolonged ruptured
membranes
bull Instrumental delivery bull Episiotomy bull Retained
placentamembranes bull Physiological third stage bull Drugs eg inhaled
anaesthetic agents bull Therapeutic anticoagulation
DIC
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
DefinitionsPrimary PPH
gt 500 ml (spontaneous delivery)gt 1000 ml (caesarean section)
Severe haemorrhage blood loss gt 150 mlmin (within 20 min causing loss of more
than 50 of blood volume)sudden blood loss gt 1500-2000 ml (uterine atony loss of 25-
35 of blood volume)
Causes of PPH the 4 TrsquosTone uterine atony distended bladder
Trauma uterine cervical or vaginal injury
Tissue retained placenta or clots
Thrombin pre-existing or acquired coagulopathy
Antenatal risk factorsbull Polyhydramnios bull Multiple pregnancy bull Fibroids bull Past PPH bull Previous retained placenta bull Previous Caesarean Section uterine
surgery bull Placenta praeviapercreta increta bull APH
bull High parity bull Maternal Age bull Obesity bull Drugs eg NifedipineMgSO4
salbutamol bull Hypertensive disorders bull Pre-existing coagulation disorder
eg Von Willebrandrsquos bull Therapeutic anticoagulation bull Anaemia
Intrapartum risks
bull Fetal demise in utero bull Abruption bull Inductionaugmentation of
labour bull Prolonged labour bull Pyrexia bull Prolonged ruptured
membranes
bull Instrumental delivery bull Episiotomy bull Retained
placentamembranes bull Physiological third stage bull Drugs eg inhaled
anaesthetic agents bull Therapeutic anticoagulation
DIC
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Causes of PPH the 4 TrsquosTone uterine atony distended bladder
Trauma uterine cervical or vaginal injury
Tissue retained placenta or clots
Thrombin pre-existing or acquired coagulopathy
Antenatal risk factorsbull Polyhydramnios bull Multiple pregnancy bull Fibroids bull Past PPH bull Previous retained placenta bull Previous Caesarean Section uterine
surgery bull Placenta praeviapercreta increta bull APH
bull High parity bull Maternal Age bull Obesity bull Drugs eg NifedipineMgSO4
salbutamol bull Hypertensive disorders bull Pre-existing coagulation disorder
eg Von Willebrandrsquos bull Therapeutic anticoagulation bull Anaemia
Intrapartum risks
bull Fetal demise in utero bull Abruption bull Inductionaugmentation of
labour bull Prolonged labour bull Pyrexia bull Prolonged ruptured
membranes
bull Instrumental delivery bull Episiotomy bull Retained
placentamembranes bull Physiological third stage bull Drugs eg inhaled
anaesthetic agents bull Therapeutic anticoagulation
DIC
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
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Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
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Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
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copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
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Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
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KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
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Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
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Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
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Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
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University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
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Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
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PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
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copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
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The InPress How it Works
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Now about that dronehelliphellip
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Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
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Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
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TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
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Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Antenatal risk factorsbull Polyhydramnios bull Multiple pregnancy bull Fibroids bull Past PPH bull Previous retained placenta bull Previous Caesarean Section uterine
surgery bull Placenta praeviapercreta increta bull APH
bull High parity bull Maternal Age bull Obesity bull Drugs eg NifedipineMgSO4
salbutamol bull Hypertensive disorders bull Pre-existing coagulation disorder
eg Von Willebrandrsquos bull Therapeutic anticoagulation bull Anaemia
Intrapartum risks
bull Fetal demise in utero bull Abruption bull Inductionaugmentation of
labour bull Prolonged labour bull Pyrexia bull Prolonged ruptured
membranes
bull Instrumental delivery bull Episiotomy bull Retained
placentamembranes bull Physiological third stage bull Drugs eg inhaled
anaesthetic agents bull Therapeutic anticoagulation
DIC
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Intrapartum risks
bull Fetal demise in utero bull Abruption bull Inductionaugmentation of
labour bull Prolonged labour bull Pyrexia bull Prolonged ruptured
membranes
bull Instrumental delivery bull Episiotomy bull Retained
placentamembranes bull Physiological third stage bull Drugs eg inhaled
anaesthetic agents bull Therapeutic anticoagulation
DIC
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Third stage of Labour
PPH ACTIVE EXPECTANT
gt500 mls 5 13
gt1000 mls 1 3
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
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Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
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Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
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copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
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KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
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Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
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Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
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Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
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University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
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Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
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PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
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copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
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The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
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Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
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TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Active vs Expectant Management
Outcome Control Rate Relative Risk 95 CI NNT dagger 95 CIPPH of 500 mL 14 038 032-046 12 10-14PPH of 1000 mL 26 033 021-051 55 42-91
Hemoglobin lt 9 gdL 61 04 029-055 27 20-40
Blood transfusion 23 044 022-053 67 48-111
Therapeutic uterotonics 17 02 017-025 7 6-8
CI Confidence intervaldagger NNT Number needed to treat
Prendiville WJ Elbourne D McDonald S Active versus expectant management in the third stage of labour Cochrane Database Syst Rev 2000 CD000007
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
AMTSL WH
1 2 3 4230
240
250
260
270
280
290
300
310
PPH Rate
1 2 3 400
20
40
60
80
100
120
Major PPH Rate
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
The GOLDEN HOURbull The first 60 minutes after the start of the PPHbull The greater the delay in starting resuscitation
the lower the percentage of survivors
bull However may not be true in trauma amp too late in PPH
bull FIRST 20 minutes
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
PPH ManagementASSESS
bull Observationsbull Cause of bleedingbull Investigations
ARRESTbull Fundal massagebull Drugs
REPLACEbull IV Fluids
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Confidential enquiries (UK)TOO LITTLE
Uterotonics Fluid Blood Blood products
TOO LATE Recognition Reaction Intervention
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Drugsbull Oxytocin - 10U IMIVbull Ergometrine - 500 mcg IVIMbull Prostaglandins
bull Carboprost ndash 250 mcg IM x8bull Misoprostol ndash 600 mg PO 800 mg PR
bull Carbetocin
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Uterotonic Drugs
Drug Dosage Action Side Effects Caution
Oxytocin 10U IMIV Onset 2-3 minsLasts 10-15 mins Minimal None
Ergometrine 500mcg IVIM Onset 2-7 minsLasts 2-4 hours
Nausea vomiting headache
hypertensionHypertension
Carboprost 250mcg IM Onset 1-2 minsLasts 15-20 mins
Vomiting diarrhoea
bronchospasmBrittle asthma
Misoprostol800mcg SLPR
600mcg POOnset 3-5 mins
Peak 20-30 minsLasts lt75 mins
Shivering rise in temperature None
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Misoprostol FIGO
bull A single dose of misoprostol 600μg orally for prevention
bull One dose of misoprostol 800 μg sublingually for treatment
bull Administered immediately after delivery of the newborn
bull Contraindications - History of allergy to misoprostol or other prostaglandin
bull FIGO 2012
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Fluids
bull Colloids vs Crystalloidsbull Volumebull Warmbull Speedbull IV lines - Two large bore IV access
ndash GreyGreen (No 16 or 18)
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
IV AccessGauge Color Flow rate
16 Grey 180 mLmin18 Green 80 mLmin20 Pink 54 mLmin22 Blue 31 mLmin
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Pressure Bag
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Otherbull Airway breathing circulationbull Oxygen by face mask ndash 6 to 8L per
minutebull Fundal massagebull O negative bloodbull Cross matched bloodbull Massive Transfusion Protocol
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Questions
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Blood loss EstimationDr Robin Burr
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
The challengesbull Visual estimationbull Measuring aidsbull Clinical impactbull Shockbull MEOWS
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Visual Estimation of Blood Lossbull Caregivers consistently underestimate
visible blood loss by as much as 50 Razvi K Chua S Arulkumaran S Ratnam SS A comparison between visual estimation and
laboratory determination of blood loss during the third stage of labor Aust N Z J Obstet Gynaecol 199636152ndash4
bull Can be improved with training using visual aidsBose P Regan F Paterson-Brown S Improving the accuracy of estimated blood loss at
obstetric haemorrhage using clinical reconstructions BJOG 2006 Aug113(8)919-24
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Blood loss ndash quick quiz 1
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Blood loss ndash quick quiz 2
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Blood loss ndash quick quiz 3
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Blood loss ndash quick quiz 4
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Blood loss ndash quick quiz 5
bull 0 - 500 mlsbull 500 - 1000 mlsbull 1000 - 1500 mlsbull 1500 - 2000 mlsbull 2000 - 2500 mlsbull gt2500 mls
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
BRASSS-V Drapetrade
bull Placed under womanbull Two ties around waistbull Blood drains into
calibrated pouch
Kodkany BS Derman RJ Goudar SS et al Initiating a novel therapy in preventing postpartum hemorrhage in rural India a joint collaboration between the United States and India Int J Fertil Women Med 20044991ndash6
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Kellyrsquos Pad
bull The patient sits on this device
bull The pad funnels the blood into a collection container which has a marked line at 500 mL
bull This device is washable and can be sterilized
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Blood Mat
bull 20rdquo x 20rdquobull = 500mls
photo Pathfinder staffBangladesh
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Local materials
Weighed gauze swabs pads
Kanga (100x155 cm) x2 = 500mls
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
PPH and shock
Blood Volume Loss Blood Pressure (systolic) Symptoms and Signs Degree of Shock
500-1000 mL (10-15) Normal Palpitations tachycardia dizziness Compensated
1000-1500 mL (15-25) Slight fall (80-100 mm Hg) Weakness tachycardia sweating Mild
1500-2000 mL (25-35) Moderate fall (70-80 mm Hg) Restlessness pallor oliguria Moderate
2000-3000 mL (35-50) Marked fall (50-70 mm Hg) Collapse air hunger anuria Severe
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Monitoring MEWSbull Observation of vital signs are an integral part of carebull There is a potential for any woman to be at risk of
physiological deterioration and this cannot always be predicted
bull There is poor recognition of deterioration in conditionbull Regular recording and documentation of vital signs
will aid recognition of any change in a womanrsquos condition
bull The use of EWS chart prompts early referral to an appropriate practitioner who can undertake a full review order appropriate investigations resuscitate and treat as required
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
MonitorIdentify Trigger
AlertEvaluate
Diagnose
Respond
MATERNAL EARLYWARNING SYSTEM
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
MEOWS Chartbull All women whose clinical condition requires close
observation admitted early pregnancy antenatal or postnatal
bull All post operative cases ndash in recovery and following transfer from theatre
bull Any woman giving cause for concern (medical or obstetric causes)
bull DuringFollowing APHPPHEclampsia bull Suspected infection eg Prolonged SROMbull High-risk women in delivery suite (not in labour)
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
The Value of MEWS chartsbull 676 consecutive obstetric admissionsbull 200 patient (30) triggered and 86 patients (13) had
morbiditybull haemorrhage (43)bull hypertensive disease of pregnancy (31)bull suspected infection (20)
bull 89 sensitive (95 CI 81ndash95)bull 79 specific (95 CI 76ndash82)bull positive predictive value 39 (95 CI 32ndash46)bull negative predictive value of 98 (95 CI 96ndash99)
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Questions
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Obstetric HDUICUDr Robin Burr
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Rationale for an Obstetric HDUbull Modified early warning scoring systems
improve the detection of life threatening illness
bull It is the subsequent management that will alter the outcome
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Other drivers for changeCEMACH 1988 - 90 ldquoproperly equipped staffed and supervised high dependency area in every consultant obstetric unitrdquo
SAFER CHILDBIRTH - 2007 ldquoall obstetric units should be able to provide some high dependency carerdquo 1 in 100 deliveries
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Advantages of an Obstetric HDUbull Concurrent availability of obstetric and critical care
management bull Awareness of physiology and pathology of the
maternity patientbull Fetal monitoring in antenatal patients bull Avoiding hazards of transfer bull Keeping mum and baby together bull Improved continuity of antenatal and postnatal care
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Disadvantages of an Obstetric HDUbull Skill levels of MidwivesObstetric Nurses
bull Skill levels of Junior doctorsbull Anaesthetic supportbull Locationbull Equipmentbull ICU outreach
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Levels of Carebull Level 0 - normal ward carebull Level 1 - needing more observation
Critical Carebull Level 2 - support of one organ
bull Basic respiratory ampor cardiovascular support bull Level 3 - advanced support
bull Advanced respiratory support alone bull Support of 2 or more organs
Providing equity of critical and maternity care for the critically ill pregnant or recently pregnant woman | July 2011
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Graduated response to deteriorationLow-score group (EWS =3)o Increased frequency of observations and the midwife in charge alerted
Medium-score group (EWS =4 5)o Urgent call to team with primary medical responsibility for the patiento Simultaneous call to personnel with core competences for acute illness
High-score group (EWS ge 6)o Emergency call to team with critical care competences and maternity team o There should be an immediate response
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Admissions to HDUbull Obstetric Indications
ndash Eclampsiandash Sepsisndash Severe pre-eclampsiandash Severe asthmandash Major haemorrhagendash Diabetic ketoacidosisndash Thromboembolismndash HELLP syndromendash Puerperal sepsis
bull Non-obstetric indicationsndash Transfer from ICUndash Other surgical procedures or complicationsndash related to surgical conditionndash Pneumonia respiratory embarrassmentndash Hypertensionndash Renal impairmentndash Thyrotoxicosisndash Cardiac or neurological co-morbidityndash Morbid obesity (BMI gt40kgm2) with
comorbidities
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Minimum equipment requirementso Piped oxygeno Suction equipmento Resuscitation equipment including ready access to defibrillatoro Pulse oximetero Non-invasive blood pressure monitoro ECG waveform monitoro Calf compression deviceo Invasive haemodynamic monitoringo Level 1 fluid infuser
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Transfers out of HDUbull Failure of more than one organ systembull Disease requiring the expertise of specialist medical teams eg
bull Renal failure other than the impairment associated with preeclampsiabull Hepatic failurebull Respiratory disease especially that requiring ventilatory supportbull Cardiac disease pre-existing or of recent onsetbull Neurological conditionsbull Endocrine disease including diabetes mellitusbull Non-obstetric surgical problems
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Transfer of carebull Guidelinesbull Clear planbull Timing of transferbull Continuity of carebull Structured formal handovers
bull summary of critical care staybull a monitoring plan detailing the frequency of observations bull An plan for ongoing treatmentbull physical and rehabilitation needs bull psychological and emotional needs bull specific communication or language needs
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Discharges to wardbull Patient haemodynamically stable no further
continuous intravenous medication or frequent blood tests required
bull No invasive monitoring requiredbull No active bleedingbull No supplementary oxygen requiredbull Patient mobilized
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
ISBAR toolIdentification identify yourself and your role to the person you are communicating with in the communicationSituation describe the specific situation about a particular patient including name consultant patient location vital signs resuscitation status and any specific concernsBackground communicate the patientrsquos background including date of admission diagnosis current medications allergies laboratory results progress during the admission and other relevant informationAssessment this involves critical assessment of the situation clinical impression and detailed expression of concernsRecommendation this includes the management plan suggestions for care detail of investigation requests and expected time frame
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
UK Obstetric HDUbull Admissions rose from 267 to 501 bull Massive obstetric haemorrhage is now the most
common reason for admission bull Invasive monitoring in 30 bull Two-thirds of neonates (663) stayed with their
critically ill mothers in the high dependency unit bull Transfer to the intensive care unit was needed in 14
per 1000 deliveries conducted
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Indian Obstetric HDUbull Admission rate - 94bull Severe PIH with complications - 26 bull Placenta praevia APH - 314 bull Abruptio placenta - 57 bull PPH - 14bull PROM with sepsis - 8 bull Medical complications in pregnancy - 242
bull HDU mortality rate was 37 (692 were preventable deaths)
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Questions
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Transfer of Patientwith PPH
PPH Module 2014
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
When to transfer the patient with PPHFrom PHC to First Referral unit Clinical assessment Class I Retained placenta Traumatic PPHFrom Nursing home with OT to Hospital with HDU amp ICU Uncontrolled Class IIFrom Labor room to OT Class II Retained placenta Traumatic PPH
(Do not wait till Class III amp IV)
PPH Module 2014
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Prerequisites for TransferInformed consentAnti shock Garment (NASG)Check availability of bed in the referral hospitalReferral documentsIndwelling catheter with UrosacVaginal pack in traumatic PPHTamponade in atonic PPHRecord presence of PackTamponade ndash Do not remove until destination
PPH Module 2014
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Referral DocumentsAntenatal Record with risk factorsIntranatal events Delivery notes VaginalInstrumentalC section Time of delivery of BabyPlacenta EpisiotomyVaginal lacerationCervical tearInvestigation results Sequence of events Medication administered with time amp dose Fluids administered Condition on Transfer
PPH Module 2014
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
On transferNasal Oxygen on flowTwo IV lines (1618) with fluid on flowNurse or Doctor amp Patientrsquos able attendant to accompany
PPH Module 2014
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
NASG Updates on Clinical Trial Results Implementation Trials Cost Effectiveness and
Global Guidelines
Professor Suellen MillerUniversity of California San FranciscoDept ObsGyn amp Reproductive SciencesDirector Safe Motherhood Program
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
What is the NASG
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Used in Over 33 Countries Globally
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Where in India
Pathfinder Raksha Project 2007-2012
Tamil Nadu Rajasthan Bijar Orrissa Maharashtra Assam Agra
Pathfinder and World Health Partners in UPDr Narendar Malhotra Rainbow HospitalsDr Sheela Mane throughout India
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Clinical Trials Tertiary Level5 peer-reviewed studies 4 pre-post design 1 (India) contemporaneous use3651 women Severe OH (gt1000 mL) with clinical sxs of shock
1614 (453) standard care 1947 547 standard care + NASGSub-analysis of Severe Shock (1227 MAP lt 60 mm HG 594 std care 633 516 std care + NASG)
Meta-analytic Techniques to pool all data
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Outcomes NASG Tertiary Level
bullLifeWrap significantly reduced mortality 48 RR 052 (95 CI 036-077)
Pileggi-Castro C Nogueira-Pileggi V Tuncalp O Oladapo OT Vogel JP Souza JP Non-pneumatic anti-shock garment for improving maternal survival following severe postpartum haemorrhage a systematic review (2015) Reproductive Health 1228
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Clinical Trials Primary Level
Zambia and Zimbabwe 2007-2012880 women transported from PHCs midwifery directed no bloodsurgeryClinics randomized to standard care vs standard care plus NASG before transport for hypovolemic shock38 clinics 5 tertiary facilitiesOUTCOMES Mortality and Time to Recovery of Shock
Similar in magnitude of effect and trend of the Tertiary FacilitiesNon-pneumatic Anti-Shock Garment (NASG) a First-Aid Device to Decrease Maternal Mortality from Obstetric Hemorrhage A Cluster Randomized Trial Miller S Bergel EF El Ayadi A Gibbons L Butrick E Magwali T Mkumba G Kaseba C My Huong NT Geissler JD Merialdi M(2013) PLOS ONE 8(10) e76477
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Pragmatic TrialImplementation Science 334 PHCs Rural Tanzania
Baseline all hemorrhage gt500 mLEndline Severe hemorrhage only gt1000 mL or signs of hypovolemia P lt 001
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Cost-Effective Analyses
bull Comparison of CEA at Tertiary Level 1442 womenbull Egypt Cost BENEFICIAL save health system $100001000 women
with shockbull Nigeria Zambia Zimbabwe Extremely COST EFFECTIVE
Cost-effectiveness of the non-pneumatic anti-shock garment (NASG) evidence from a cluster randomized controlled trial in Zambia and Zimbabwe Downing J El Ayadi A Miller S Butrick E Mkumba G Magwali T Kaseba-Sata C Kahn JG (2015) BMC 1537Use of the Non-pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage A Cost-Effectiveness Analysis in Egypt and Nigeria Sutherland T Downing J Miller S Bishai DM Butrick E Fathalla MF Mourad-Youssif M Ojengbede O Nsima D Kahn JG (2013) PLOS ONE 8(4)e62282
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Non-Pneumatic Anti Shock Garment(NASG)
PPH Module 2014
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
NASG (Life Wrap)
It applies pressure on the legs amp abdomenBlood returns to vital organs curbing internal bleedStabilizes BP until patient reaches appropriate hospitalEasy to applyApplication time takes lt 60 seconds in trained hands
PPH Module 2014
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
How does NASG work
It is a First AidControls bleeding through direct pressureAuto transfusion of blood in upward directionBall in abdominal segment applies focused pressure to uterusCircumferential pressure on lower half of the body reduces the total vascular spaceVital organs get increased blood supply amp oxygenationStabilization of patient during transport
PPH Module 2014
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
How does NASG work
In shock the brain heart and lungs are deprived of oxygen because blood accumulates in the lower abdomen and legs in addition to blood loss from the vagina during obstetric hemorrhage
The NASG applies circumferential counter pressure which reverses shock bull By returning blood to the vital organs bull Decreasing blood flow in the compressed areasbull Decreasing blood loss
PPH Module 2014
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
NASGrsquos Unique Role in Obstetric Hemorrhage and Hypovolemic ShockUsed with hemorrhage therapies uterotonics massage vaginal procedures even surgeriesDoes not compete with other approaches Not an either or situation first-aid device that buys timeA technology that can be used when patient with uterine atony does not respond to uterotonicsANDEffective for ALL obstetric hemorrhage rupture lacerations ectopicOnly technology that reverses shock until blood transfusions
Can be used with balloon tamponade to reverse shock
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
About NASG
NASG is light weight (1500 G)Compression suit made of NeopreneFive segments enclosing ankle thigh calves pelvis amp abdomenVelcro fastenings to keep garment tightA small foam ball in the abdominal segment applies pressure on the uterusMarkings on the sections show how to apply
PPH Module 2014
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
About NASG
Correct tight application supplies 20 to 40 mm Hg of circumferential pressure to lower body effectively reversing hypovolemic shockCan be easily packed back into carry bag
PPH Module 2014
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
NASG (Life wrap)
PPH Module 2014
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Applying NASG
Step 1 Place NASG under the woman with the top at the level of lowest ribClose segment 1 tightly around ankle on both sidesSnap it until you hear a sharp sound
Step 2Close segment 2 around calf muscleLeave the knee joint free
PPH Module 2014
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Applying NASGStep 3Apply segment 3 around the thighs
Step 4Apply segment 4 all around the woman with the lower edge at the level of pubic bone
PPH Module 2014
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Applying NASG
Step 5Place segment 5 with pressure ball directly over umbilicusClose the NSAG using segment 6
Only one person should close segment 4 amp 5Should not be too tight to restrict breathing
PPH Module 2014
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Applying NASG
Step 6Ensure patient is breathing normally after the applicationIn case of uterine atony administer uterotonics amp massage the uterus without removing the NASGNASG is flexible enough to allow the massaging
PPH Module 2014
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Vaginal Procedures with NASG in situ
Pelvic examinationLithotomy positionRepair of episiotomy Perineal tear Vaginal laceration Cervical tearMRPBimanual compressionDampC DampE MVA
PPH Module 2014
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Surgery with NASG in situLaparotomy (Keep segments 12amp3 in situ and open pelvic amp abdominal segments 45amp6 just prior to incision)Steep Trendelenberg positionOperate quicklyReplace segment 4 5 amp 6 after procedure
PPH Module 2014
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Special situations
Obese women
Short stature
Need for defecation
Replacing soiled NASG
PPH Module 2014
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
When to remove NASGPatient must be stable for 2 hoursBleeding lt50 mlhr Pulse lt100 BPMSystolic BP 90-100 mm Hg Hb gt7G Patient conscious amp aware
PPH Module 2014
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
How to remove NASGRemove segment 1 amp wait for 15 mtsCheck pulse amp BPIf pulse rate increases gt20 BPM or BP falls by 20 mm Hg Reapply segment 1If vitals stable remove segment 2Follow same principles till removal of segment 6
PPH Module 2014
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Do not remove NASG before all vital signs are restored
Early removal of NASG can be dangerous or even fatal
PPH Module 2014
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
CautionIf BP falls by 20 mm Hg or Pulse increases by 20 BPM after removal of any segment rapidly replace all segments
Consider need for crystalloids Blood
If recurrent bleeding determine source amp arrest
PPH Module 2014
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Storing NASG
Clean NASG with running water amp disinfectant and dryKeep folded NASG in a clear plastic bagStore NASG in a place where it is visible amp accessibleAlways store at the same placeEnsure every one knows place of storageStorage place should be displayed prominentlyThe referral center must send a replacement NASG after receiving the patient
PPH Module 2014
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Relative contraindications
Cardiac failurePre existing Mitral stenosis Pulmonary edema Advanced pregnancy with live fetus (APH)Abdominal eviscerationOpen pelvic fracture
PPH Module 2014
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Principles to be observedOne person alone can apply NASGTwo persons needed when patient is unconsciousUrine output should be measuredEnsure airway protection amp Prevent aspirationEnsure one on one nursing care
PPH Module 2014
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Advantages of NASG50-78 Reduction in blood loss
50-55 Reduction in Maternal Mortality amp related Morbidity
WHO includes NASG in recommendations
Cost effective
Reusable
PPH Module 2014
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
World Scenario 2013Used in 16 Countries
UK amp USARemote Rural areas
Jehovarsquos witness
Zambia ampZimbabwePeri urban
centers
Tamil NaduAll levels
Ambulance108
PPH Module 2014
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Added toWHOGuidelinesfor PPH in2012
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
FIGO Guidelines
1 Non-pneumatic anti-shock garment to stabilize women with hypovolemic shock secondary to obstetric hemorrhage FIGO Safe Motherhood and Newborn Health Committee (2014) httpdxdoiorg101016jijgo201410014
2 FIGO GUIDELINES Prevention and treatment of postpartum hemorrhage in low-resource settings FIGO Safe Motherhood and Newborn Health (SMNH) Committee International Journal of Gynecology and Obstetrics 117 (2012) 108ndash118 doi101016jijgo201203001
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Partnership for Distribution in LMICEMECUN
bull United Nations Commission on Life Saving Commodities for Women and Childrenrsquos Healthbull CHAIbull UCSFSafe Motherhood Programbull BlueFuzion UNGM (United Nations Global Marketplace)bull Higher Quality Lower Price Increased Reusability
bull $030 usebull $4200garment and WashReuse Cycles ~ 140 times
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Hemorrhage Etiologies UCSF
29
11
16
12
4
7
2
19Atony
Lacerations
Retained
Placenta
Ruptured Ut
Ectopic
Other
Abortion
N = 4191
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Safety
gt 10000 documented casesNO REPORTS of any safety issuesNO INCREASE of side effects minor or major due to use of NASG
Used now routinely in AfricaAsiaSouth AmericaLarge-Scale Pragmatic ldquooperations researchrdquo in Tanzania East Timor and others
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Conclusions
bullStatistically significant decreases in time to return to normal Shock Index in quasi-experimental and RCTs bullAt the TERTIARY LEVEL~ 58 significant reduction in MORTALITY across several quasi-experimental studiesbullRandomized Trial at PHCEarlier Application 64 reduction in mortality ns bullCost Effective or Cost-BeneficialbullOn WHO and FIGO GUIDELINES UN Marketplace VendorNASG AICOG bullIn 10000 cases carefully documented there were no adverse events related to NASG use SAFEbullNow in use in over 33 countries globally
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
QUESTIONS
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
PPH Module 2014
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Thank You
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Innovations in Triage and Treatment of Obstetric Hemorrhage
PRESENTED BYPROF NARENDRA MALHOTRAMDFICOGFICMCHFICSFRCOG
copy Suellen Miller 2016
Professor Suellen MillerUniversity of California San Francisco
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
the most common and severe type of obstetric haemmorrhage is still an enigma to the present day obstetrician as it is sudden often unpredicted assessed subjectively and can be catastrophic The clinical picture changes so rapidly that unless timely action is taken maternal death occurs within a short period
POST PARTUM HAEMORRHAGE
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Identify PPH Risk Factors
bull Pre-eclampsiabull Nulliparitybull Multiple gestationbull Previous post-partum haemorrhagebull Previous caesarean sectionbull 60 have no risk factors
bull Prolonged 1st amp 2nd stagebull Prolonged active third stage (gt30 min)bull Arrest of descentbull Episiotomybull Lacerations cervical vaginal perinealbull Assisted birthbull Use of oxytocics
Ante-natal
Intra-partum
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Be Ready for it all the time l
Drill is a practice and anticipation amp task allotment to tackle emergencies Fire drillearth quake drill etc etcPPH drill should be taught practised and rehearsed in obstetric set up so that every one is prepared for the emergency and know what to do
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
136
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Emergency Trolley
Endotracheal tube Laryngoscope
Essential drugs
Crystalloids giving sets haemacel
Emergency protocols
GENERAL MANAGEMENT
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Large bore IV cannulas (gauge 14 x 2)Crystalloids
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Teamwork
Key learning points
To understand the importance of good team workingTo understand that effective communication is vital in emergency situationsTo appreciate the different roles and responsibilities of members of a multiprofessional teamTo understand the importance of shared decision making within the teamTo recognise the value of being able to lsquostand back and take a broader viewrsquo in an emergency situation
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
TRIAGE Early Identification of Hemorrhage
First Delay
Recognizing Complications
Second Delay
Deciding to Seek Care
Third DelayAccessing Transport
Fourth Delay
Receiving Care at Facility
TRIAGE Early Identification of HemorrhageTREATMENTS Stop Bleeding Stabilize for Transport
copy Suellen Miller 2016
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Low Tech Blood Loss Assessment
350 mL
500 mLcopy Suellen Miller 2016
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
GOES UNDER THE BUTTOCK OF MOTHER
RINGS-A string from each go around the buttockto be tied together suprapubically for double fixing
REUSABLE TYPE BLOOD COLLECTOR PAN
(DEBDAS)
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Vital Signs as PredictorsBlood loss estimate not a reliable predictor of outcomePulse and Blood Pressure measurements are often difficult to obtain accuratelyPP Circulatory changes VS changes may be detected too lateMore sensitive predictor of adverse outcomes and management tool neededShock Index PulseSystolic BP
copy Suellen Miller 2016
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
copy Suellen Miller 2016
Developed by Kingrsquos College LondonProf Andrew Sheenan Hannah NathanNatasha Helzegrave
CRADLEMicrolifeTraffic Light Vital Sign Alert (VSA)
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Suitable for Use in Low Resource Setting
Parati et al 2005
bull Accuratebull Affordable - $19 per unitbull Easy to use bull Robustbull Low power requirementsbull A lifetime use of gt20000 extreme inflationsbull Can be used with a stethoscope as an alternative to a mercury columnbull Hypertensive Disorders amp HypertensionShock
copy Suellen Miller 2016
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Shock Index ThresholdsHRSBP
SI ge 17
SI 09 ndash 169
SI lt09
Nathan HL El Ayadi AM Hezelgrave NL Seed P Butrick E Miller S et al (2015) Shock index an effective predictor of outcome in postpartum haemorrhage BJOG 122(2)268-75
copy Suellen Miller 2016
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
KCL CRADLE Researchbull Prospective clinical evaluation of device and traffic light system ongoing in South Africabull Larger Prospective Stepped Wedge Randomised Trial
Collaborating with KLE University IndiaEvaluating impact of CRADLE VSA on maternal deaths SMOs in 10 low-
income country sites
copy Suellen Miller 2016
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Phone Pulse Oximeter
Pulse Oximeter noninvasive measures oxygen saturation by shining infrared light through the finger (measures redness of blood) low oxygen saturation in hypovolemic shockThe Phone Oximeter is a smartphone application which receives data in real time from a connected pulse oximeterMinimal Training lt$5000unitDeveloped at University of British Columbia part of Global PRE-EMPT
copy Suellen Miller 2016
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Triage TRIGGER ACTION
Recognition of HemorrhageShockINITIATE ACTION Stop Bleeding
Medical Treatment bull UterotonicsCarboprost (025 mg IM)bull TXA IV administrationbull Pressure Massage Bimanual Compression Aortic Compression
Treat ShockIV fluidsWarmth Trendelenberg
ReferraltransportDefinitive Therapies
bull Bloodbull Surgery copy Suellen Miller 2016
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
LifeWrapNASGUnique first aid device reverses shock and decreases blood loss mitigates delays in transport and at facilitiesTested on 10000 women 5 studies Systematic Review published in BMC RH showed ss 48 decrease in mortality ss 69 reduction in SMOWHO FIGO AICOG PPH GuidelinesUnited Nations Commission on Life Saving Commodities for Women and Childrenrsquos Health CHAIUCSFSafe Motherhood Program and Blue Fuzion$030 use--$4200 and Wash Cycles gt 100
copy Suellen Miller 2016
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Laerdal Compression Belt
St Georgersquos Hospital and University of LondonCurrently being tested in Sri LankaUterinepelvic vessel compression with an inflatable cuff on the uterus and an inflatable cuff on a suprapublic wedge
VS Talaulikar et al IJGO 2015 A pilot study of the impact of a novel compression belt on pelvic blood flow in healthy postpartum women copy Suellen Miller 2016
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
copy Suellen Miller 2016
University of Liverpool The ButterflyProf Andrew Weeks
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Improving on Current Treatments
copy Suellen Miller 2016
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Innovative ultra low cost (less than USD $3 per UBT device) package
DeviceTargeted trainingChecklists
ESM-UBTTM
bull 235 women severe hemorrhage arrested in 233 of 235bull 98 of women with severe uncontrolled hemorrhage
survived bull Survival fell to 83 if an improvised UBT device was used
instead of one that was prepackaged and readily availableMass General Global Health Thomas Burke
Burke TF et al A postpartum hemorrhage package with condom UBT A prospective multi-center case series in Kenya Sierra Leone Senegal and Nepal BJOG July 21 2015copy Suellen Miller 2016
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
The UBT device arrests hemorrhage directly at the site of disrupted vessels
copy Suellen Miller 2016
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
PATHSINAPI UBT KIT
PATH is working closely with SINAPI biomedical in South AfricaThe SINAPI Balloon meets a critical need in low-resource settings for an affordable easy to use fully assembled UBTWhen inserted into the uterus and filled with water the UBT exerts pressure that stops the bleeding within 5 to 15 minutesGravity-fed filling mechanism makes it easier amp faster Clinical trials to take place in 2016 to confirm safety
PATHrsquos low-cost UBT solution is promising for expanding access to life-saving PPH treatments
SIN
API b
iom
edic
alC
hristi
aan
van
Aard
t
copy Suellen Miller 2016
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
copy Suellen Miller 2016
Synergy of TXAThrombinUBT
In porcine and murine testinggas generating microparticles of CaCO3 with TXA and thrombin self propel (through lateral propulsion buoyant rise and convection) to the bleeding site and function hemostatically to halt hemorrhage for traumatic and intraoperative bleeding
Model Concept would be toapply TXAThrombinCaCO3
to a UBT both to enhance drug delivery and apply physical Tamponade
Baylis et al Self-propelled particles that transport cargo through flowing blood and halt hemorrhageSci Adv 2015
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
The InPress
1 Seal created in birth canal2 Light vacuum force uterine
cavity 3 Uterus contracts and vessels
constricted
bull Immediately assess the efficacy of the treatmentbull Allows physician to accurately measure blood loss
Clinical Experience 10 patients in Jakarta IN
bull Hemorrhaging controlled lt2 minutesbull Device removal unremarkable no recurrence of bleedingbull CE Mark Application and Pre-IDE Submission to FDA
copy Suellen Miller 2016
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
The InPress How it Works
copy Suellen Miller 2016
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
copy Suellen Miller 2016
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
copy Suellen Miller 2016
Now about that dronehelliphellip
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
copy Suellen Miller 2016
Health facility orders blood via mobile1 Drone can carry up to 10 kg
in 75 km radius3
Drone drops package at health facility in 15-45 min4
Zipline Rapid On-demand Aerial Delivery of BloodUterotonicsEmergency Supplies
dispatches a drone with package2
Ifakara Health Institute Tanzania amp Zipline Inc Pilot SLAB Grant
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Zipline Delivers BloodMedicationsLifeWraps in Rwanda amp Tanzania
copy Suellen Miller 2016
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Conclusions Innovations Now and On the HorizonTriage
CradleMicrolife Traffic Light Vital Signs Device (SI) Early Warning Device can be used at any level of the health care system
Phone Pulse Oximeter (O2 Saturation)
Medications Carboprost TXANASG to decrease bleeding reverse shock stabilize women until definitive careAbdominal Compression Belt and Butterfly DeviceVariety of low cost intrauterine tamponade devices
DIY condom ESM-UBT Kit PATHSINAPI UBT UBC UBT + CaCO3TXAThrombin model
Drones and solar power (blood banks) may bring blood transfusion capacitydrugsLifeWraps closer to where women bleedcopy Suellen Miller 2016
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Balloon Tamponade
bullA balloon (inflated with salinewater) exerts pressure to stop bleeding from within the uterus in 5-15 minsbullIs very effective (ge85) when uterotonics fail Can prevent need for laparotomy and hysterectomy (Reported success rates for the control and management of PPH with uterine tamponade are quite high and range between 70-100)bullEasy to usebullCan effectively be used in low resource settings
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
INDIAN INNOVATIONSDEBDAS BLOOD ESTIMATION SYSTEMCONDOM BALLON TAMPONADEUTERINE PACKING
copy Suellen Miller 2016
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
TAMPONADE TESTTherapeutic amp PrognosticFor severe PPH
Stomach balloonOesophagealballoon
Condous G Arulkumaran S etal Obstetrics amp Gynecology 2003
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
182
Balloon TamponadeAtonic PPH unresponsive to uterotonic drugsSimple inexpensive easy to use and effective Does not require special surgical skillsTemporarypermanent control of PPHBuys time to institute definitive treatmentBuys time to shift the patient
Condom tamponade
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
WHO RECOMMENDATIONS
1- Uterotonics Play a central role in treatment
2-uterine massage is advised
3- initial crystalloids recommended
4--use of Tx in refractory trauma bleeding
5-intrauterine balloon in refractory bleeding and when uterotonic not available
6-Bimanual uterine compression
7-external aortic compression
use of non pneumaticanti shock garments as temporizing measures
8- still not controlled then Uterine aa embolization should b considered
9-Despite all if not controlled then surgical intervention should b done without delay
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
Thank You
AcknowledgementsElizabeth Abu Haider PATHSINAPI UBT Mark Ansermino amp Beth Payne UBC Phone OximeterChristian Kastrup UBC UBTCaCO3TXAThrombin Jessie Becker Amy Degenkolb Jan Segnitz Nathan Bair Inpress DeviceVikram S Talaulikar amp Sabaratnam ArulkumaranSt Georgersquos Hospital Compression BeltAndrew Weeks Liverpool University ButterflyHannah Nathan Andrew Sheenan KCL CRADLEMicrolife VSAThomas Burke U of Mass ESM-UBTZac Mtema amp Godfrey Mbaruku IHIZipline TanzaniaNick Hu Zipline California USA
copy Suellen Miller 2016
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
copy Suellen Miller 2016
Thank You
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU
MILLENIUM DEVELOPMENT GOALSAre nowSUSTAINABLE DEVELOPMENTAL GOALS
THANK YOU