NHS Foundation Trust Reducing the risk and management of

Reducing the risk and management of venous thrombo-embolism (VTE) in pregnancy MCPOD OBS 3.8 Version 2.4

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Aug 2012 PEedarapalli, JMainwaring, DWebster, EPeachey, ABabbington, DTerrot Pg 1 of 31

The Royal Bournemouth and Christchurch Hospitals

NHS Foundation Trust

Reducing the risk and management

of venous thrombo-

embolism (VTE) in pregnancy


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SUMMARY POINTS

This procedure:

Aims to develop and implement a robust process to ensure that appropriate risk assessments are undertaken and acted upon to reduce the risk of maternal death from thrombosis or thrombo-embolism

Aims to ensure all women should undergo an assessment of risk factors for VTE in early pregnancy or before pregnancy

Provides information on care and treatment

DOCUMENT DETAIL

Author: Dr P Eedarapalli, Dr J Mainwaring, Mr D Webster,

E Peachey, A Babbington, D Terrot

Job Title:

Consultant Obstetrician, Consultant Haematologist,

Consultant Obstetrician, Maternity Risk Manager, VTE

Lead Pharmacist, Lead Paediatric Pharmacist

Signed:

Date: August 2012

Version No: 2.4

Document Reference No: OBS 3.8

Next Review Date: August 2015

Approving Body/Committee: East Dorset Maternity Approved Documentation group,

Drug and Therapeutics Committee

Chair: Miss L Melson,

Dr Richard Day

Signed:

Date Approved: March 2012 (EDMAD), August 2012 (Poole D&T)

Target Audience: All Obstetric and Maternity staff


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DOCUMENT HISTORY

Date of

Issue

Version

No.

Next

Review

Date

Date

Approved

Director

Responsible for

Change

Nature of Change

28.11.09 1 January 2013

January 2010

Dr P Eedarapalli, Dr J Mainwaring

January 2012

2 May 2015 May 2012 Mr. D P Webster Lead Consultant Risk Management

Update and changes to reflect compliance with Trust document control

July 2012 2.1 July 2015 Mr D P Webster, Dee Terrot (Pharmacist), Anneka Babbington

Clarification of dose times wrt epidural catheters. Parenteral Anticoagulation Prescriptions added as an appendix.

August

2012

2.2 August

2015

August

2012

Dr J Mainwaring,

Mr D Webster,

D Terrot

Agreed to use same APTTR monitoring and heparin loading dose as other adults. Post-delivery doses clarified and Rxs and appendices amended

August

2012

2.4 August

2014

August

2012

D Terrot RBH logo added. Weight ranges amended to include 90kg. Anti-Xa levels info amended.


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TABLE OF CONTENTS

1 RELEVANT TO…………………………………………...………………………..… 6

2 PURPOSE………………………………………………...………………………….. 6

3 DEFINITION………………………………………………………………………… 6

4 GLOSSARY………………………………………………………………………….. 6

5 ASSOCIATED DOCUMENTS…………………….…..……………………………. 6

6 DOCUMENT CONTENT …………………………………….……………………… 7

6.1 Introduction ………………………………………………………………………… 7

6.2 Factors associated with increased incidence of VTE in pregnant women 8

6.3 Antenatal thrombosis risk assessment ………………………………………... 8

6.4 Thrombophilia ………………………………………………………………………. 9

6.5 Thromboprophylaxis in pregnant women ……………………………………. 10

6.6 Care during labour and delivery for women on a thromboprophylactic

dose of LMWH ……………………………………………………………………. 10

6.7 Care during labour and delivery for women on a therapeutic dose of

LMWH ……………………………………………………………………………….. 10

6.8 Care during labour and delivery for women on a therapeutic dose of

subcutaneous or intravenous unfractionated heparin ……………………... 11

6.9 Epidural catheter insertion and women receiving LMWH ………………….. 11

6.10 Epidural catheter removal and women receiving LMWH …………………… 11

6.11 Thromboprophylaxis after caesarean section or vaginal delivery with

other risk factors for VTE ………………………………………………………… 12

6.12 Breast-feeding and anticoagulants …………………………………………….. 12

6.13 Deep Vein Thrombosis ……………………………………………………………. 12

6.14 Pulmonary Embolism ……………………………………………………………... 13


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6.15 Acute management for women with suspected/ diagnosed PE ………….. 15

6.16 On-going management for women with DVT/ PE ……………………………. 16

7 REFERENCES………………………………………………………………………. 19

8 APPROVAL PROCCESS………………………………………………………….. 20

9 DISSEMINATION……………………………………………………………………. 20

10

REVIEW AND REVISION ARRANGEMENTS INCLUDING VERSION

CONTROL………………………………...………………………………………….. 20

11 ARCHIVING…………………………………………………………………………... 20

12 PROCESS FOR RETRIEVING ARCHIVED DOCUMENTS………...………….. 20

13

MONITORING COMPLIANCE AND EFFECTIVENESS FOR CONTROLLED

DOCUMENTS………………………………………………………………………... 21

APPENDICES

APPENDIX 1 – Outpatient Risk Assessment for venous thromboembolism

(VTE) 22

APPENDIX 2 – Inpatient Risk Assessment for venous thromboembolism

(VTE) 24

APPENDIX 3 – Thromboprophylaxis in pregnant women 25

APPENDIX 4 – Dalteparin Quick Dosing Guide for Obstetric Patients During

Pregnancy and the Puerperium 28

APPENDIX 5 - Link to Parenteral Anticoagulation Prescription for Use in

Pregnant and Post-natal Patients Only 30

APPENDIX 6 – Monitoring Factor Anti-Xa in Patients on LMWH 31


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1. RELEVANT TO

1.1 All Obstetric and Midwifery staff working within East Dorset Maternity Services

2. PURPOSE

2.1.1 To develop and implement a robust process to ensure that appropriate risk assessments are undertaken and acted upon to reduce the risk of maternal death from thrombosis or thromboembolism

3 DEFINITION

3.1.1 This is a procedure for implementing risk assessment and management of venous thrombo-embolism in pregnancy

4 GLOSSARY

DVT - Deep vein thrombosis

PE- Pulmonary embolism.

VTE - Venous thromboembolism

RPOC – Retained products of conception FBC – full blood count INR – international normalized ratio LMWH – low molecular weight heparin PPH –post-partum haemorrhage COCP – combined oral contraceptive pill CTPA - computed tomographic pulmonary angiogram VWF – von Willebrand factor

5 ASSOCIATED DOCUMENTS

OBS 2.6 Caesarean Section Guideline

OBS 5.10 Maternity Recovery Guideline


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OBS 2.9 High dependency Care

OBS 2.8 Modified Early Warning System in Obstetrics

6 DOCUMENT CONTENT

6.1 Introduction

6.1.1 Incidence of deep vein thrombosis (DVT) in pregnant women is 0.05 – 0.1% which is at least 5 - fold greater than women who are not pregnant or taking the oral contraceptive pill.

6.1.2 5 - 10% of pregnant women with an iliofemoral DVT develop a pulmonary embolism (PE).

6.1.3 DVT is more common in the left leg; (85%) of events. In 72% of women the DVT affects the iliofemoral veins, which is possibly related to the fact that the right iliac artery crosses the left iliofemoral vein.

6.1.4 Venous thromboembolism (VTE) often has no symptoms – in over half of deep vein thromboses, there are no symptoms at all. However, a serious complication of deep vein thrombosis (DVT) is pulmonary embolism (PE), where the blood clot from a deep vein breaks away, travels within the bloodstream, and blocks the blood supply to the lungs.

Signs and Symptoms of Venous Thromboembolism (VTE):

Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE)

Swelling of the calf, ankle or foot

Sharp chest pain (worse during deep breathing)

Tenderness or pain in the calf or upper leg

Shortness of breath (dyspnoea) and/or hyperventilation

Purple or blue discoloration of the skin on the leg

Coughing up of blood (haemoptysis)

Increased warmth of the leg Rapid heart beat (tachycardia)

Redness of the skin (erythema)

Feeling faint/faint

6.1.5 The symptoms that are seen with DVT and PE are similar to those produced by many other conditions and this may make diagnosis difficult.


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6.2 Some women are at even higher risk because they have one or more additional risk factors (Table1, RCOG)

Factors associated with the increased incidence of VTE in pregnant women include:-

Venous stasis within lower limb veins caused by extrinsic compression of the

uterus on iliofemoral veins;

Venous atonia related to hormonal changes affecting venous return;

Raised clotting factor levels especially factors I, VII, VIII and VWF;

Reduced naturally occurring anticoagulants such as Protein S;

Decreased fibrinolysis related to raised levels of so-called plasminogen

activator inhibitor 1 and 2.

Table1. Risk factors venous thromboembolism in pregnancy and puerperium

Preexisting New onset or transient

Previous VTE Surgical procedure in pregnancy or Family History of VTE Eg.,evacuation of RPOC, postpartum Current smoker sterilization Thrombophilia Hyperemesis Congenital Dehydration Antithrombin deficiency Ovarian Hyperstimulation syndrome Protein C deficiency Severe infection, pyelonephritis Protein S deficiency Immobility (>4 days bed rest) Factor V Leiden Pre-eclampsia Prothrombin gene variant Excessive blood loss Acquired (antiphospholipid syndrome) Long-haul travel Lupus anticoagulant Prolonged labour

Anticardiolipin antibodies Midcavity instrumental delivery Age over 35 years Immobility after delivery Obesity (BMI>30) either pre or early pregnancy Parity≥3 Gross varicose veins Paraplegia Sickle cell disease Inflammatory disorders e.g., Inflammatory bowel disease Some medical disorders, e.g., nephrotic syndrome, certain cardiac diseases Myeloproliferative disorders e.g., essential thrombocythaemia, polycythaemia vera

6.3 Antenatal Thrombosis Risk Assessment

6.3.1 All women should undergo an assessment of risk factors for VTE in early pregnancy or before pregnancy. Please use form in Appendix 2 - Outpatient Risk Assessment for venous thromboembolism (VTE). Women attending for their first antenatal visit should be asked specifically about their personal and family history of VTE and


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whether any diagnosis was objectively confirmed. If this information is not available, investigate the history of anticoagulant treatment. Where prolonged anticoagulant therapy has been prescribed, in keeping with the management of VTE, it is prudent to assume that this has been a definite event.

6.3.2 This assessment is to be repeated at 28 and 34 weeks (please refer to Appendix 2) and whenever a woman is admitted to hospital or develops other intercurrent problems (please refer to Appendix 3 if patient admitted). High risk women who may need prolonged thromboprophylaxis should be referred to the Consultant Haematologist. Thromboprophylaxis may be initiated by the Consultant Obstetrician if clinically indicated. However, it may be deferred until Haematologist’s advice if expert opinion is required. The risk of VTE should be discussed with high risk women and reasons for individual recommendations. All management plans must be documented in the hand held and hospital notes. All women treated as high risk for VTE or diagnosed with VTE should be offered a postnatal appointment with the Consultant Haematologist or Consultant Obstetrician.

6.3.3 If admitted to a gynae ward within the first post-natal month (approximately), women should be VTE risk assessed using the maternity assessment chart (Appendix 2).

6.4 Thrombophilia

6.4.1 This can be an inherited or acquired increased tendency towards thrombotic disease, usually venous > arterial.

6.4.2 Pregnant women with a personal history of VTE or a family history of VTE may be offered screening for thrombophilia. Indications include:-

VTE aged < 50;

Recurrent VTE;

VTE in unusual site such as axillary, cerebral or mesenteric vein;

Strong family history of VTE, especially first degree relatives;

Family history of known thrombophilia defect;

Unexplained recurrent miscarriages;

Previous warfarin induced skin necrosis – seen in Protein C / S deficient patients.

6.4.3 Generally it is best to perform thrombophilia screens when women are not pregnant

because of the fact that pregnancy is associated with high factor VIII levels leading to acquired Protein C resistance and reduced Protein S levels but sometimes this is unavoidable. In selected cases a limited thrombophilia screen for the Factor V Leiden and Prothrombin gene mutations/ antithrombin level/ anticardiolipin antibodies plus a lupus anticoagulant may be useful. It is best to perform the screens when patients


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are not receiving heparin that lowers antithrombin or warfarin that lowers Protein C / S levels.

6.5 Thromboprophylaxis in Pregnant Women (See Appendix 4)

6.5.1 Note that booking (or early pregnancy) weight should be used for prophylactic doses.

For LMWH dosing please refer to Appendix 5 – Dalteparin Quick Dosing Guide for Obstetric Patients.

6.5.2 To minimise the risk of thrombosis when travelling long distances (e.g., over 4 hours, especially by air), pregnant travellers should consider:

GECS (Graduated elastic compression stockings);

A single injection of a LMWH 2-4 hours before travel at prophylactic dose (GECS);

Patient already receiving warfarin should continue to take it ( GECS).

6.5.3 It is recommended that LMWH are the agents of choice for antenatal

thromboprophylaxis as they are as effective as and safer than unfractionated heparin. Warfarin should be avoided if possible during pregnancy and at least between 6 and 12 weeks, plus after 36 weeks gestation. Antenatally and postnatally all women at high risk for VTE should encouraged wear Class-II GEC below knee stockings. Class-I GECS however are appropriate for hospital inpatients at increased risk for VTE and for pregnant women travelling by air.

6.6 Care During Labour And Delivery For Women On a Thromboprophylactic Dose of LMWH

6.6.1 If the woman is receiving a high prophylactic dose, LMWH should be reduced to a lower prophylactic dose, preferably as a once-daily treatment on the day before induction of labour or an elective caesarean section and continued at this dose during the process of induction. All prophylactic management plans must be documented in the hand held and hospital notes.

6.6.2 Once the woman is in labour or thinks she is in labour, she should be advised not to inject any further heparin/ LMWH. She should be reassessed on admission to hospital and further doses should be prescribed by medical staff.

6.6.3 If an epidural is requested, refer to point 6.9.

6.6.4 If there is no bleeding, prophylactic LMWH can be given 12 to 24 hours after delivery or caesarean section (see Appendix 3).


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6.7 Care During Labour and Delivery for Women on a Therapeutic Dose of LMWH

6.7.1 For elective caesarean sections, omit treatment doses of LMWH for 24 hours before surgery.

6.7.2 If the patient has received a full dose of LMWH within the last 24 hours and is in labour then regional analgesia is not appropriate. If regional analgesia is required then haematology advice regarding use of protamine should be sought (out of hours, Specialist Registrars can be contacted via switch).

6.7.3 Provided there are no concerns about bleeding, the appropriate thromboprophylactic dose(s) should be used for 24 hours following delivery or elective caesarean section. The first dose of LMWH should be given by 3 hours post-operatively (more than 6 hours after epidural catheter removal, if appropriate). The treatment dose can then be recommenced after 24 hours if haemostasis has been secured.

6.7.4 If bleeding is an issue post-delivery, LMWH doses would need to be deferred until the bleed had resolved.

6.8 Care During Labour for Women on a Therapeutic Dose of Subcutaneous or Intravenous Unfractionated Heparin

6.8.1 Subcutaneous unfractionated heparin should be discontinued 12 hours before induction of labour or regional anaesthesia.

6.8.2 Intravenous unfractionated heparin should be discontinued 6 hours before induction of labour or regional anaesthesia.

6.9 Epidural Catheter Insertion and Patients Receiving LMWH

6.9.1 Before inserting an epidural catheter it is important to ensure that the coagulation screen is normal and platelet count > 100 x 109/L.

6.9.2 If LMWH has been given for thromboprophylaxis, there should be a gap of at least 12 hours before the epidural is performed. This is to avoid the risk of a post catheter insertion bleed leading to the development of a spinal haematoma.

6.9.3 Similarly, if LMWH has been given for therapeutic anticoagulation, there should be a gap of at least 24 hours before an epidural is performed.

6.9.4 The same time limits apply for spinal anaesthesia.

6.10 Epidural Catheter Removal and Patients Receiving LMWH

6.10.1 There should be a gap of at least 6 hours between removing the epidural catheter and giving LMWH.


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6.10.2 Where possible, prescribe LMWH doses at 6pm (and 8am if on BD dosing) on the drug chart. Elective C section patients can then have their catheter removed at 2pm and their LMWH dose at 6pm

6.11 Thromboprophylaxis after Caesarean Section or Vaginal Delivery with other Risk Factors for VTE

6.11.1 Please see appendix 3 for high – risk patients undergoing C / Section etc.

6.11.2 In essence if the patient has > 3 risk factors then LMWH once daily will be recommended starting 6 hours post delivery if no bleeding problems occur (see 6.7 if spinal anaesthesia or epidural catheter used).

6.11.3 Once daily doses by weight are given in Appendix 4. These doses should be used unless BD dosing is advised for a particular patient by haematology.

6.11.4 Initial doses will be based on most recent weight. It is good practice to check post delivery weights for all women and amend the prescribed LMWH dose accordingly. This is particularly important for those women with extremely low or high weights.

6.11.5 LMWH should be continued for at least 7 days or until the patient is fully mobile. Also recommend GECS.

6.12 Breast Feeding and Anticoagulants

6.12.1 There is no evidence that the amounts of either LMWH or warfarin are sufficiently high in breast milk to cause the baby to bleed. Therefore mothers receiving these drugs can safely be treated for VTE during breast feeding.

6.13 Deep Vein Thrombosis

6.13.1 Remember the risk factors and have a high index of suspicion

6.13.2 Signs and symptoms

Low grade pyrexia;

Slight tachycardia;

Calf pain or feeling of heaviness;

Oedema of leg;

Change in leg colour and temperature;

Positive Homan’s sign (pain in the calf on dorsiflexion);


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Back pain and swollen limb if iliac vein thrombosis.

6.13.3 Investigations for diagnosis of DVT

Doppler ultrasound leg studies (requested through the ultrasound scan department or refer to DVT clinic during working hours);

Confirm normal renal and hepatic function by FBC, coagulation screen, urea and electrolytes (U and E) and liver function tests (LFT) prior to anticoagulant therapy;

If all investigations are negative anticoagulant treatment should be

discontinued;

A thrombophilia screen is not routinely recommended. Acute Management for Women with Suspected/Diagnosed DVT

6.13.4 Early involvement of senior staff, (obstetric registrar and consultant and anaesthetist)

include physicians

Assess ABC; Be alert for signs of PE and report significant changes to a senior obstetrician

immediately; Arrange appropriate investigations urgently; Treat with low-molecular-weight heparin (LMWH THERAPEUTIC DOSE) until

the diagnosis of DVT is excluded, unless such treatment is strongly contraindicated;

Most recent weight should be used for treatment doses of LMWH; On diagnosis: treat with anticoagulants throughout pregnancy and for at least

6 weeks postnatally, but at least until 3 months treatment has been received (see Appendix 3);

Elevate the leg; Apply graduated elastic stockings; Encourage mobilisation / maintain hydration.

For calculation of THERAPEUTIC DOSE of LMWH by most recent weight please see Appendix 5 - Dalteparin Quick Dosing Guide for Obstetric Patients.


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6.14 Pulmonary Embolism

6.14.1 Signs and symptoms- remember the risk factors and have a high index of suspicion.

May present with central Chest pain and collapse if PE large

Evidence of DVT (15%)

Sudden onset dyspnoea Tachypnoea Tachycardia Pleuritic chest pain Cough, haemoptysis Pyrexia though may also be apyrexial Dizziness Feeling flu-like Jugular venous distension Crepitations and pleural rub

6.14.2 Investigations for diagnosis of PE:

All women should be reviewed by an experienced doctor (Specialist Registrar) who will liaise with the consultant in charge regarding the investigations and management;

Recommend and offer portable Chest x-ray (CXR) to exclude pneumothorax

or pneumonia; X-ray findings may show collapse, raised hemi diaphragm, pleural effusion, consolidation, wedge infarction or may be normal. (Regarding radiological investigations in pregnancy, the radiation dose thought to be dangerous to the foetus is 0.5 rad. A CXR is associated with < 0.001, venogram < 0.05, VQ scan < 0.05 and CT pulmonary angiogram < 0.05 rad exposure);

Consider duplex Doppler of lower limbs- if CXR and Doppler normal but still

high index of suspicion perform VQ scan or CTPA; D-dimers; D-dimers are not diagnostic of an acute thromboembolism event

as the physiological changes in the coagulation system mean they are raised towards term and in the postnatal period. They can also be raised with other conditions such as pre-eclampsia. However a low level of D-dimer in pregnancy is likely to suggest that there is no venous thromboembolism. D-dimers are available out of hours, (use light blue sodium citrate bottle);

FBC, coagulation screen, U&E, LFT and arterial blood gases prior to

commencing anticoagulant therapy if possible. A thrombophilia screen is not routinely recommended;

ECG: may show right bundle branch block, sinus tachycardia, S1Q3T3;


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VQ scan (ventilation perfusion scan): discuss with the on call radiologist, the ventilation part is often omitted in pregnancy and the radiation dose is lower than CTPA. It has a high negative predictive value;

CTPA may be necessary- fetal thyroid function should be checked in the

neonate if CTPA has been performed in pregnancy – a neonatal alert proforma;

Liaise with chest physicians or on call medical registrar.

6.15 Acute Management for Women With Suspected/Diagnosed PE

6.15.1 Collapsed, shocked patients (life-threatening P.E) need to be assessed by a multidisciplinary team of experienced clinicians

Assess ABC; Early involvement of senior staff, (obstetric registrar and consultant,

anaesthetist, ODP) Include physicians and radiologist; Collapsed, shocked women need urgent assessment by a multi-disciplinary

team to consider pulmonary artery catheter break up of clot, embolectomy or thrombolysis if situation is life threatening. Immediate thrombolysis should be considered if a massive PE is confirmed or, in extreme circumstances, prior to confirmation;

Assess and manage in HDU;

Arrange appropriate investigations urgently; Monitor BP, pulse, oxygen saturation, urine output and cardiac rhythm; If hypotensive – give 500ml crystalloid, consider inotropes if remains low; Consider arterial line and central line.

Massive P.E-Management 6.15.2 The extended consultant team should decide whether in the above circumstances,

the investigation / treatment of P.E should be:-

IV unfractionated heparin or thrombolytic therapy or thoracotomy or surgical embolectomy;

In massive PE, IV unfractionated heparin should be administered after

consulting the physicians / cardiologists; An urgent portable ECHOCARDIOGRAM or CTPA within 1 hr of presentation.


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IV HEPARIN TREATMENT: Most recent weight should be used to determine treatment doses with both unfractionated heparin and LMWH. LOADING DOSE: 75 units/kg (to nearest 100 units) by IV bolus injection (max 5000units) Omit loading dose if patient received thrombolysis FOLLOWED BY: Continuous infusion 18 units/kg/hr (to nearest 100 units)

To make the infusion use 20,000units/20ml vial and draw up into a 50ml syringe (DO NOT DILUTE) Adjust dose according to APTT – Aim for 1.5-2.5 x lab APTT value Measure APPT : 6 hours after loading dose 6 hours after any dose change At least daily when in therapeutic range

Infusion rates according to activated partial thromboplastin time (APTT):

APTTR Adjustment to heparin rate (1000units / mL)

Monitor APTT Ratio

> 5 Stop for 1 hour then reduce by 0.6mL / hr

Inform Dr After 2 hours

4.1 to 5.0 Reduce by 0.4mL / hr After 6 hours



1.5 to 2.5 NO CHANGE After 10 hours

1.2 to 1.4 Increase by 0.2mL/hr After 6 hours

< 1.2 Increase by 0.4mL / hr

Discuss with Dr to consider a bolus. After 4 hours

6.16 Ongoing Management for Women With DVT/PE

Give information leaflet: ‘venous thrombosis in pregnancy and after birth’; Properly fitted compression stockings need to be worn during pregnancy and

after delivery; Teach self administration of anticoagulant therapy when appropriate, including

safe disposal of sharps; Routine platelet count monitoring should not be performed (unless

unfractionated heparin has been used);


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Routine measurement of peak anti-Xa activity for women on LMWH for acute

treatment of VTE in pregnancy or postnatally is not recommended, except in women at extremes of body weight (booking weight <50kg and >90kg) or with other complicating factors putting them at high risk e.g. renal impairment, recurrent VTE;

Women who are considered to be at high risk of haemorrhage and in whom

continued heparin treatment is considered essential should be managed with intravenous unfractionated heparin until risk factors have resolved;

Women receiving therapeutic-dose unfractionated heparin should have their

platelet count checked on days 1 and 5 of treatment and then every 3rd to 5th day thereafter to monitor for heparin-induced thrombocytopenia. Consult haematology if a 50% or more reduction is observed;

Inform the woman’s known midwife and GP on discharge from hospital.

Ongoing Antenatal Management for Women With DVT/PE

Referral to antenatal anaesthetic clinic; For women having CT PA trigger a neonatal alert in view of the iodine

contrast used (thyroid function testing of the baby in the first month is recommended);

Ensure out-patient follow-up by obstetrician and haematologist;

Advise to stop anticoagulant therapy if she thinks she is in labour and contact

central delivery suite as soon as possible; Discontinue LMWH 24 hours prior to planned birth.

Ongoing Management In Labour For Women With DVT/PE

Regional anaesthetic/analgesic techniques should not be used until at least 24 hours after last therapeutic dose of LMWH;

Consider wound drains and interrupted skin closure for women having

caesarean section; There should be a clear management plan for the continued treatment of the

VTE determined by mode of birth, analgesia etc.

Ongoing Postnatal Management for Women With DVT/PE

Advise that neither heparin nor warfarin is contra-indicated in breastfeeding;


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Offer a choice of LMWH or warfarin for postnatal treatment, include the need for regular blood tests for monitoring warfarin;

Avoid warfarin until at least the third day post delivery and for longer in

women at increased risk of postpartum haemorrhage; De-brief; Offer hospital postnatal appointment with the named consultant for advice

regarding the need for thromboprophylaxis in future pregnancies; Inform GP and the woman’s known midwife of outcome; Advise immediate referral in future pregnancies; Offer thrombophilia screen after treatment completed; In view of the iodine contrast used in CT PA thyroid function testing of the

baby in the first month is recommended. Complete a neonatal alert form.


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7 REFERENCES

Confidential Enquiries into Maternal Deaths in the United Kingdom. (2001). Why Mothers Die 1997-1999. London: CEMD. Available at: www.cmace.org.uk Confidential Enquiry into Maternity and Child Health. (2004). Why Mothers Die 2000-2002. London: RCOG Press. Available at: www.cmace.org.uk Confidential Enquiry into Maternity and Child Health. (2007). Saving Mothers’ Lives: Reviewing maternal deaths to make motherhood safer - 2003-2005. London: CEMACH. Available at: www.cmace.org.uk National Institute for Health and Clinical Excellence. (2004). Caesarean Section. London: NICE. Available at: www.nice.org.uk National Institute for Health and Clinical Excellence. (2007). Intrapartum care: Care of healthy women and their babies during childbirth. London: NICE. Available at: www.nice.org.uk National Institute for Health and Clinical Excellence. (2010). Venous thromboembolism: reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to hospital. London: NICE CG92. Available at: www.nice.org.uk National Institute for Health and Clinical Excellence. (2007). Intrapartum care: Care of healthy women and their babies during childbirth. London: NICE. Available at: www.nice.org.uk

Royal College of Obstetricians and Gynaecologists, Royal College of Anaesthetists, Royal College of Midwives, Royal College of Paediatrics and Child Health. (2008). Standards for Maternity Care: Report of a Working Party. London: RCOG Press. Available at: www.rcog.org.uk

Royal College of Obstetricians and Gynaecologists. (2007). Thromboembolic disease in pregnancy and the puerperium: Acute management. London: RCOG. Available at: www.rcog.org.uk Royal College of Obstetricians and Gynaecologists. (2009). Reducing the risk of thrombosis and embolism during pregnancy and the puerperium. London: RCOG. Available at: www.rcog.org.ukRoyal College of Obstetricians and Gynaecologists Guideline 2003 – Thromboprophylaxis during pregnancy and after normal vaginal delivery.

Scottish Intercollegiate Network (SIGN) guidelines, 2002. Shiach C et al., 2004, Monitoring low molecular weight heparin in pregnancy:the timing of the peak measurement. British Journal of Haematology , 125(1): 58. Walker I et al. 2001, Investigation and management of heritable thrombophilia, British Journal of Haematology 114: 512 – 528.


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Salisbury NHS Foundation Trust website, Davies P (Pharmacy), Dalteparin – Guidelines for Prescribing Revision 2.0 Review date 03/10/2013

8 APPROVAL PROCESS

8.1.1 This guideline will be approved by the East Dorset Maternity Approved documentation group, and the Trust’s Drug and Therapeutics Group.

9 DISSEMINATION

9.1.1 This policy will be made available on the Trust Intranet following approval and will be subject to the document control procedures. It will also be available in clinical areas as a paper copy in the policies and guidelines folder.

9.2.1 The guideline will be disseminated by all Consultants, Matrons and Band 7 Lead midwives.

10 REVIEW AND REVISION ARRANGEMENTS INCLUDING VERSION CONTROL

10.1.1 The document and the plan will be reviewed every three years or earlier when significant guidance is issued.

10.2.1 All revisions are subject to the approval of the appropriate Committees.

11 ARCHIVING

11.1.1 All archived documents will be migrated into the web asset management system and hard copies will also be kept by the Midwifery Risk Manager.

12 PROCESS FOR RETRIEVING ARCHIVED DOCUMENTS

12.1.1 Copies of archived documents migrated into the Intranet Web Asset Management System can be retrieved by authors and publishers who have the relevant permissions to access the Intranet Web Asset Management System. In emergencies IT will be able to provide necessary access.

12.2.1 Retrieving archived documents prior to the Intranet Web Asset Management System is the responsibility of the author.

12.3.1 The previous Intranet version of documents will be archived and will be accessible by the IT department.


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13 MONITORING COMPLIANCE AND EFFECTIVENESS OF PROCEDURAL DOCUMENTS

13.1.1 In order to provide Maternity Services with assurance of implementation of the guideline and the provision of safe clinical care the following process of monitoring will be utilised.

13.2.1 The Supervisors of Midwives are also responsible for reviewing the audit results and developing action plans for any of the criteria that are less than 100%.

Guideline for management of Venous Thrombo-embolic disease (VTE) in pregnancy

Audit Method

Lead responsible for audit and report submission

Frequency of audit

50 sets of notes

Contact Supervisor of Midwives

Annually

Audit criteria:

Has the VTE risk assessment proforma been completed? Was the correct action taken for those identified with risks? Did the woman receive thrombo-prophylaxis in pregnancy, and if so is

there an individual management plan documented?

The audit report will be submitted to the delivery suite forum for monitoring to the supervisors of midwives and to the obstetric management group

The action plan and its implementation is the responsibility of the Matron (s), Deputy Head of Midwifery Changes in practice identified will be taken forward and implemented by the Lead Obstetrician and the Lead Midwives.

APPENDICES ON FOLLOWING PAGES:


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J l 2012 V7 3 CLM/PAS/DPW

Outpatient Risk assessment for Venous Thromboembolism (VTE) in pregnancy

Height……………… Weight………….. BMI………………

RISK ASSESS AT BOOKING and REASSESS WHENEVER CLINICAL SITUATION CHANGES

FOR ANY RISK IDENTIFIED: USE YELLOW ALERT STICKER AND PAGE 17 OF HAND HELD NOTES

Table 1 HIGH thrombotic risk if one or more ticks Refer to consultant clinic

Bkg

20-30 wks

30-40 wks

Bkg

20-30 wks

30-40 wks

Previous VTE Antenatal thromboprophylaxis

Known thrombophilia Table 2 Significant bleeding risk if one or more ticks Refer to consultant clinic

Bkg

20-30

wks

30-40 wks

Bkg

20-30

wks

30-40

wks

Uncontrolled BP (≥ 200/110) Active bleeding Acute fatty liver/HELLP with low platelets Thrombocytopenia

(platelets ≤ 75)

Inherited bleeding disorder Table 3 High thrombotic risk if ≥ 3 ticks Refer to consultant clinic Low thrombotic risk if <3 ticks

Bkg

20-30

wks

30-40

wks

Bkg

20-30

wks

30-40 wks

Age ≥ 35 yrs Current infection Para 3 or more Pre-eclampsia Obesity – BMI ≥ 30 Reassess at 16/40 if 2 ticks at booking

Prolonged bed rest, immobility ≥ 3 days

Multiple pregnancy or Assisted Reproduction Treatment (ART)

Current hyperemesis, dehydration,

Current smoker Gross varicose veins Family history VTE ≥ 4 hrs travel within 2 weeks Risk

Level High/Low

Print Name Signature Date Referral Made Yes/No

Booking Assessment

20-30 week Assessment

30-40 week Assessment

ADDRESSOGRAPH


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Further Reassessments (eg when clinical situation changes): Date Risk

Level High/Low

Print Name Signature Referral Made Yes/No

KEY LMWH = Low molecular weight heparin Bkg = Booking visit HELLP = syndrome with haemolysis, elevated liver enzymes and low platelet count Please complete VTE risk assessment at booking appointment and refer to Consultant/Obstetric clinic if High Risk If the booking assessment identifies 2 risk factors in Table 3, please reassess at the 16 week appointment to account for the BMI calculation. If this identifies a 3rd risk factor, treat as high risk and refer to consultant clinic Reassess in each trimester or if clinical situation changes and refer as above Tick all boxes that apply and make assessment accordingly


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In-patient Venous thromboembolism (VTE) risk assessment for pregnant womenAll inpatients must be assessed on admission

Step 1: Assess thrombosis risk – tick all boxes that apply. 1 tick or more = HIGH RISK, prompt thromboprophylaxis

1 2 3 1 2 3 Emergency Caesarean section Antenatal thromboprophylaxis Known thrombophilia Previous VTE Surgical procedure (not obstetric) Step 1: Continued – tick all boxes that apply. 2 ticks or more = HIGH RISK, prompt thromboprophylaxis

Patient related Patient related Age ≥ 35 yrs Significant co morbidity Elective Caesarian Section PPH ≥ 1 litre or blood transfusion Para 3 or more Mid-cavity, instrumental delivery Obesity – BMI ≥ 30 at booking Pre-eclampsia Current smoker Prolonged labour ≥ 24 hrs Gross varicose veins Any surgical procedure in puerperium Family history VTE Critical care admission ≥ 4 hrs travel within 2 weeks Prolonged bed rest, immobility ≥ 3 days Multiple pregnancy or Assisted Reproduction Treatment (ART)

Current hyperemesis, dehydration, ovarian hyperstimulation, sickle crisis

Step 2: Assess bleeding risk- tick all boxes that apply. Any tick is contra-indication to anticoagulant drugs

Uncontrolled BP (≥ 200/110) Active bleeding Acute fatty liver/HELLP with low platelets Epidural/spinal expected within 12 hrs or had

epidural/spinal within prev. 6 hrs

Thrombocytopenia (platelets ≤ 75) Induction of labour Inherited bleeding disorder Active labour/ early labour

Contra-indication to LMWH or Heparin (Insert Y = yes, N = no) Step 3: Contra-indications (tick if present) Contra-indication to anti-embolism stockings (Insert Y = yes, N =

no)

Step 4: Thromboprophylaxis Appropriate (y = yes, N = no)

High / Low Risk Name (Print) & Job title (Dr or MW) Signature Date Assessment 1



Day of prophylaxis (start date = day

1)

→

VTE prophylaxis

Date→ Time ↓

Aim to give OD LMWH doses at 1800 Drug

Route Dose Start date

Pharmacy

Anti-embolism Stockings (Y = yes, N = no)

Dr. Name/ signature

If prophylaxis inappropriate, contra-indicated or stopped, give reason

Assessment 1 to be completed on admission See Maternity Guideline MCPOD OBS 3.8 Assessment 2 to be completed following delivery or if clinical situation changes Assessment 3 to be completed if clinical situation changes Notes: Booking (or pre-pregnancy) weight to be used for thromboprophylactic LMWH dose determination

LMWH doses should not be given for at least 4 hours post-removal of spinal or epidural catheter. Epidural catheters s should not be removed within 12 hours post LMWH dose.


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THROMBOPROPHYLAXIS IN PREGNANT WOMEN Condition Risk factor Antenatally Postnatally Comments

Past history of spontaneous DVT/PE

Prophylactic dose of LMWH (Low Molecular Weight Heparin) as soon

as pregnancy confirmed

If no bleeding start prophylactic dose of LMWH 12-24 hours after delivery

Options then include continuing daily

LMWH as above for 6-8 weeks. Alternatively, start warfarin the day after LMWH was introduced, initially 9mg on days 1 & 2, then FBC/INR on day 3. Dose of warfarin would then depend on INR result. Once

INR >2 then LMWH can stop. Warfarin would continue for 6-8

weeks, aiming for target INR of 2.5 (range 2-3).

Increase intake of calcium via drinking milk or taking calcium

tablets in view of the small risk of heparin induced osteoporosis. Risk is much lower with LMWH

like Clexane than unfractionated heparins like calcparin

Postnatally: If the patient

refuses LMWH or warfarin an alternative, though not

affording the same thromboprophylactic protection would be ASPIRIN 75mg od for

6-8 weeks Women on long term anticoagulation (excluding those with prosthetic cardiac valves)

AS ABOVE AS ABOVE Please refer to haematologist from consultant obstetric

antenatal clinic

Past history of pregnancy or oestrogen related DVT/PE

Prophylactic dose of LMWH starting 4 weeks prior to onset of last VTE

AS ABOVE

Past history of DVT/PE with a precipitating factor – post operative, post long-haul flight etc.

Postnatal rather than antenatal thromboprophylaxis

AS ABOVE If major iliofemoral DVT or PE related to COCP, may have to consider antenatal plus postnatal thromboprophylaxis

Heterozygous factor V Leiden, or Prothrombin gene mutation, protein C or protein S deficiency, type 2 antithrombin deficiency , raised factor VIII or homocysteine

Postnatal rather than antenatal thromboprophylaxis

AS ABOVE


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Condition Risk factor Antenatally Postnatally Comments ASYMPTOMATIC/ NO HISTORY OF

DVT

Asymptomatic patients who have never had a VTE but have been found to have the following thrombophilic defects – homozygous Factor V Leiden or Prothrombin gene mutation, type 1 antithrombin deficiency, compound defects (2 or more)

Antenatally – Prophylactic dose of LMWH as soon as pregnancy confirmed.

AS ABOVE

Asymptomatic patient with confirmed antiphospholipid syndrome (APLS = lupus inhibitor + anticardiolipin antibodies etc) Also applies to patients with APLS and recurrent miscarriages i.e. ≥ 3 pre 12 weeks or > 2 post 12 weeks

AS ABOVE and aspirin 75mg OD as soon as pregnancy is confirmed

No history of a VTE can either be daily LMWH for 6-8 weeks, LMWH initially then Warfarin for 6-8 weeks or alternatively aspirin 75mg for 6-8 weeks; as even in asymptomatic patients, APLS is a significant factor for VTE’s. LMWH or warfarin depends on preference of patient.

Stop aspirin after 37-38 weeks because the anti-platelet effects can last 7 days increasing the likelihood of PPH

Recurrent miscarriages with another thrombophilic defect such as heterozygous Factor V Leiden or Prothrombin gene mutation. Protein C or S deficiency, type 2 antithrombin deficiency, raised Factor VIII or homocysteine

Aspirin 75mg OD. Stop at week 37-38

AS ABOVE


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Condition Risk factor Antenatally Postnatally Comments

Recurrent miscarriages with no identifiable thrombophilic defect and no personal history of VTE

Aspirin 75mg OD Stop at week 36 Nothing required

Women without previous VTE or thrombophilia (Out patient) USE OUTPATIENT RISK ASSESSMENT FORM FOR VTE IN PREGNANCY

3 or more current or persisting risk factors

Should be considered for prophylactic LMWH antenatally and graduated elastic compression stockings (GECS)

Consider prophylactic LMWH for at least 7 days postpartum

Clinical judgment is required with regard to weighting of the risk factors (e.g. age over 35, and BMI over 30 are important independent risk factors for postpartum VTE, even after vaginal delivery). If the woman is discharged home early, her thromboprophylaxis should be continued at home to complete the course of 7 days, although the risk of VTE reduces if the woman is mobile it does not disappear.

Women admitted to hospital during pregnancy or up to 6 weeks postpartum. USE VTE RISK ASSESSMENT FORM FOR PREGNANT WOMEN – for inpatients

Women undergoing surgery, including caesarean section

Consider LMWH + mechanical methods (GECS plus or minus Flotron boots)

LMWH is used for 7 days for all emergency caesarean sections

The decisions to offer VTE prophylaxis and duration of treatment should involve senior obstetricians (and haematologists in complex cases) and take into account the benefits to the patient versus the risk of bleeding (see risk assessment form)


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Appendix 5

Link to Parenteral Anticoagulation Prescription for Use in Pregnant and Post-natal Patients Only Please click here.


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Monitoring Factor Anti-Xa in Patients on Low Molecular Weight Heparin Routine monitoring of anticoagulant effect is not required except in special circumstances -

Patients having treatment doses for more than 10 days and who have a creatinine clearance between

20 and 30ml/min Obesity (BMI > 30kg/m2) Pregnancy Those at increased risk of bleeding Surgical bridging patients

Samples for anti-Factor Xa activity are taken 3 to 4 hours after injection to check peak levels. For once daily dosing we aim for a 3-4 hour post-Rx anti-Xa of 1 – 2.0 iu/ml and for twice daily dosing 0.5 – 1 iu/ml generally speaking. Contact haematology medics for all pregnant and surgical bridging patients and if anti-Xa levels are <1 or >2units/mL for ONCE DAILY dosing, <0.5 or >1units/mL for TWICE DAILY dosing. In the majority of patients only PEAK levels will be measured, however a pre dose trough level will be needed if Anti-Xa level >2 units/ml for OD dosing or > 1.6 units/ml in BD dosing (taken prior to next dose). This is guidance from Dr Jason Mainwaring as it is useful to know what should be recommended but ideally a haematologist should be consulted: IN ONCE DAILY DOSING

Peak anti-Xa level 3 to 4 hours post-treatment (units/mL)

Hold next dose Dosage change Next anti-Xa Level

<0.5 No Discuss with haematology

medics 4hrs after next dose

0.5 < 0.7 No Increase by approximately 20% 4hrs after next dose

0.7 < 1 No Increase by approximately 10% 4hrs after next dose

1 - 2 No No change Within 5 to 7 days

> 2 Until pre-treatment

Anti-Xa is < 0.5

Discuss with haematology

medics Before and 4hrs after next dose

IN TWICE DAILY DOSING Peak anti-Xa level 3 to 4 hours post-treatment (units/mL)

Hold next dose Dosage change Next anti-Xa Level

<0.3 No Increase by 25% 4hrs after next dose

0.3-0.49 No Increase by 10% 4hrs after next dose

0.5-1 No None Within 5 to 7 days

1.1-1.5 No Decrease by 20% 4 hours after next dose

1.6-2 Until pre-treatment

Anti-Xa is < 0.5 Decrease by 30% Before and 4hrs after next dose

>2 Until pre-treatment

Anti-Xa is < 0.5 Decrease by 40%

Before and 4 hours after next

dose


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As per advice above, patients with levels outside of standard range should be discussed with haematology at earliest opportunity. A supply of graduated syringes will be kept in pharmacy – multi dose vials are not suitable for use in pregnancy due to the benzoyl alcohol content. Version 1.3 Linda Porter (Pharmacy) August 2012


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EQUALITY IMPACT ASSESSMENT – SCREENING FORM

1. Title of document/service for assessment Reducing the risk and management of VTE in pregnancy

2. Date of assessment August 2012

3. Date for review August 2014

4. Directorate/Service Trust-wide

5. Approval Committee D&TC

Yes/No Rationale

6. Does the document/service affect one group less or more favourably than another on the basis of:

Race No

Gender (including transgender) No

Religion or belief No

Sexual orientation, to include heterosexual, lesbian, gay and bisexual people

No

Age No

Disability – learning disabilities, physical disabilities, sensory impairment and mental health issues

No

Marriage and Civil Partnership No

Pregnancy and Maternity No

7. Does this document affect an individual’s human rights?

No

8. If you have identified potential discrimination, are the exceptions valid, legal and/or justified?

N/A

9. If the answers to any of the above questions is ‘yes’ then:

Tick Rationale

Demonstrate that such a disadvantage or advantage can be justified or is valid

Adjust the policy to remove disadvantage identified or better promote equality

If neither of the above possible, submit to Diversity Committee for review.

10. Screener(s) Print name: Jacqui Bowden 11. Date Policy approved by Committee

July 2012

12. Upon completion of the screening and approval by Committee, this document should be uploaded to papertrail.

Documents

NHS Foundation Trust Reducing the risk and management of