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4/22/2013
1
IUDInsertion and Removal
Patty Cason, MS, FNP‐BCUCLA School of Nursing
Planned Parenthood Los Angeles
Disclosure
Merck:
• Gardasil; Advisory board
• Gardasil, NuvaRing, Implanon, Nexplanon; S k / iSpeaker/trainer
Teva
• ParaGard; Advisory board, speaker/trainer
ObjectivesObjectives
• Demonstrate the hand skills necessary for placement of the copper IUC and the two levonorgestrel IUCs
Li t th j li ti th t i k
3
• List three major complications that are a risk with IUC placement and how to manage them
Take Home the “IUCs”Take Home the “IUCs”
• Keep one in your lab coat
• One in each room
• Give them to your patient to hold, feel and l i h hil di i h h dplay with while discussing the method
• Show her how to feel the threads with it
Terminology
Old name• IUD: Intrauterine DeviceNew names• IUC: Intrauterine Contraception
A li d C T380 (P G d®)
5
–Applied to Cu‐T380 (ParaGard®)–Generic term for all three
• IUS: Intrauterine System–Applied to LNG‐IUC (Mirena®)
“Skyla is now FDA‐approved...
...as a new *”
“LARC”Long Acting Reversible g g
Contraception
4/22/2013
2
The Case for LARC Methods
• More than 1/3 of all U.S. women will have had an induced abortion by age 45
• 20% of women selecting sterilization at age < 30 years later express regret
7
years later express regret
• Need for effective contraceptive methods that are “forgettable”
HenshawHenshaw. . FamFam PlannPlann PerspectPerspect 19981998HillisHillis et al. et al. ObstetObstet GynecolGynecol 19991999Stanwood, NL. Stanwood, NL. ObstetObstet GynecolGynecol 20022002
U.S. Pregnancies: Unintended vs. Intended
Unintended Unintended
Intended Intended
8
Finer LB et al. Contraception 2011;84:478Finer LB et al. Contraception 2011;84:478--485485HenshawHenshaw: : FamFam PlannPlann PerspectPerspect 1998;30:241998;30:24--2929..
Unintended birthsUnintended births
Elective AbortionsElective Abortions
Contraceptive Use During Month of Unintended Pregnancy
43% 43% used contraceptionused contraception
9
5% consistent 5% consistent method use: method use:
method failuremethod failure
52% did not use 52% did not use contraceptioncontraception
Guttmacher Institute In Brief Series 1 2008.
Contraception by Age (2008)
49
40
50
60
IUD
Steriliz
10
0.9
18.820.7 20.9
12.5
2.2 1.9 0.53.82.1
4.4
0
10
20
30
15-24 25-34 35-44
Steriliz
OCP
Ring
Mosher WD. National Survey of Family Growth. Series 23, Number 29 August 2010
What are LARC Methods?
• Long Acting Reversible Contraception– IUCs: LNG‐IUC’s ,Cu‐T380A – Implants: Etonogestrel Implant• Long term continuous protection 24/7/365 protection for 3 10 years
11
protection… for 3‐10 years• Do not require episodic patient initiative for use
• Not daily• Not weekly• Not monthly• Not even every 12 weeks
Why LARC Methods?
• The most effective methods & among the safest
• They are “forgettable”
• Require just one motivational act
• Superior continuation and highest patient f h d
12
satisfaction rates among methods
• An alternative to surgical sterilization
• The most cost saving methods of contraception
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3
Savings per dollar expenditure by contraceptive method, Family PACT 2003
13Foster, D. G. et al. Am J Public Health 2009;99:446-451
What’s in a Name?
“LARC”
• Top tier
• Highly effective, and reversible
• The best methods we have
• What health care providers use
• Safest and most effective…
Tiered Effectiveness
Tiered Effectiveness
• We don’t need to exhaustively run through each of the methods with each client.
• The goal of contraceptive counseling:
Effectiveness and Continuation Rates
Perfect Use
Typical Use
Continuation rate
Implant (Implanon) 0.050.05 0.050.05 84%84%
Male sterilization 0.100.10 0.150.15 100%100%
IUC
18Hatcher, RA et al; Contraceptive Technology 20th Edition,: 2011 *Skyla Bayer data
•LNG‐IUC (Mirena)•Cu‐T 380 (ParaGard)•Skyla*
0.20.20.60.60.40.4
0.20.20.80.8
80%80%78%78%
Female sterilization 0.50.5 0.50.5 100%100%
DMPA 0.20.2 6.06.0 56%56%
OCs, Patch, Ring 0.30.3 9.09.0 67%67%
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4
IUCS
Intrauterine Contraception in the U.S.
Copper TCopper T‐‐380380 LNGLNG‐‐IUCIUC
Mechanism Spermicidal effect Spermicidal effect of copperof copper
Thickening of Thickening of cervical mucuscervical mucus
20
Duration Up to 10 yearsUp to 10 years Up to 5 yearsUp to 5 years
Efficacy 0.8 failures/hwy 0.8 failures/hwy 0.2 failures/hwy0.2 failures/hwy
Benefit No hormonesNo hormones Less bleedingLess bleeding
Non‐contraceptive use
NoneNone MenorrhagiaMenorrhagiaMenstrual painMenstrual pain
Client Choice of IUC Type
• Copper T IUC
• Don’t want or can’t use hormonal
• LNG IUC’s
• Want less menstrual flow
21
contraception
• Like having a regular menses
• Hx dysmenorrhea
• OK with possible amenorrhea
Timing of placement of Intrauterine Contraception
Timing Pros Cons
With mensesWith menses•• Ensures patient Ensures patient not pregnantnot pregnant
•• Scheduling Scheduling
•• Interim Interim pregnancypregnancy
22
Any timeAny time•• ConvenienceConvenience
•• Low expulsion Low expulsion rate rate
••Must exclude Must exclude pregnancypregnancy
Emergency Emergency contraception contraception (Cu T only)(Cu T only)
•• Pregnancy Pregnancy preventionprevention
•• Convenience Convenience
••Not cost effective Not cost effective if used only for ECif used only for EC
Alvarez PJ. Ginecol Obstet Mex. 1994.O’Hanley K, et al. Contraception. 1992..
Copper T IUC: Mechanism of ActionCopper T IUC: Mechanism of Action
• Primary mechanism is prevention of fertilization
–Reduce motility and viability of sperm
23
of sperm
– Inhibit development of ova
• Inhibition of implantation is a secondary mechanism
Alvarez F, Brache V, Fernandez E, et al. Fertil Steril. 1988;49:768Segal SJ, Alvarez-Sanchez F, et al. Fertil Steril. 1985;44:214.ACOG. Statement on Contraceptive Methods, Washington DC:ACOG, July 1998Rivera R, Yacobson I, Grimes D, Am J Obstet Gynecol 1999;181:1263-9Stanford JB, Mikolajczyk RT, Am J Obstet Gynecol 2002; 187:1699-708
LNGLNG‐‐IUC’s: Mechanism of ActionIUC’s: Mechanism of Action
• Cervical mucus thickened
• Sperm motility and function inhibited
24
• Endometrium suppressed
• Ovulation inhibited (in some cycles)
Jonsson et al. Contraception 1991;43:447Videla-Rivero et al. Contraception 1987;36:217Rivera R, Yacobson I, Grimes D, Am J Obstet Gynecol 1999;181:1263-9Stanford JB, Mikolajczyk RT, Am J Obstet Gynecol 2002; 187:1699-708
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LNG‐20 IUC Physical CharacteristicsLNG‐20 IUC Physical Characteristics
m Steroid Steroid ii
32 mm
25
levonorgestrellevonorgestrel20 20 g/dayg/day
32 m reservoirreservoir
LNGLNG‐‐13.5 13.5 IUCIUC
• 3.8 mm insertion tubetube
• Levonorgestrel14 g/day
• Decreases to 5g/d
• Average:• 6 g/d over 3
years
27
• 3‐6 months for full effect on the endometrium
• Possible spotting during this time
LNGLNG‐‐IUC: “Off Label”IUC: “Off Label”NonNon‐‐contraceptive Benefitscontraceptive Benefits
• Decreased
– Dysmenorrhea
– Iron deficiency anemia
– Long term risk of endometrial & ovarian cancer
• Can be left in place during and after transition to menopause for use with ET
ACOG Practice Bulletin. No. 73: Use of hormonal contraception in women with coexisting medical conditions. Obstet Gynecol. 2006;107:1453–1472.
Wan YL, Holland C. The efficacy of levonorgestrel intrauterine systems for endometrial protection: a systematic review. Climacteric. 2011;14(6):622‐32.
LNGLNG‐‐IUC: “Off Label”IUC: “Off Label”Additional Therapeutic UseAdditional Therapeutic Use
• Symptomatic fibroids
• Endometrial hyperplasia
• Symptomatic endometriosis, adenomyosis
Matteson KA, et al. Nonsurgical Management of Heavy Menstrual Bleeding: A Systematic Review. Society of Gynecologic Surgeons Systematic Review Group. Obstet Gynecol. 2013; 121(3):632‐643.
Fraser IS. Added health benefits of the levonorgestrel contraceptive intrauterine system and other hormonal contraceptive delivery systems. Contraception. 2013 Mar;87(3):273‐9
MetaMeta‐‐Analysis: Analysis: MirenaMirena®® vs. Ablation for vs. Ablation for Heavy Menstrual BleedingHeavy Menstrual Bleeding
• Equal rates of treatment failures
• Equal improvements in quality of life
• Less need for analgesia/anesthesia in LNG‐IUC
30
g /group
• Ablation requires additional contraception
Kaunitz, et al. OG. 2009 May;113(5):1104-16b.
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6
Menstrual Effects: LNG‐IUC
• Hypomenorrhea; intermenstrual bleeding
• Management
– Exclude PID, pregnancy; ectopic
– NSAID’s
31
– If persistent bleeding, check for anemia
• Remove IUC if abnormal bleeding is unacceptable to patient
Menstrual Effects: Cu IUC
• Heavier or longer menses or dysmenorrhea
– Exclude PID, pregnancy
– NSAIDs prophylactically WITH FOOD
• Pre‐emptive use for first 3 cycles
• Start before onset of menses anti prostaglandin
32
• Start before onset of menses‐‐ anti‐prostaglandin effect
–Naproxen sodium 220mg x2 BID (max 1100mg/day)
– Ibuprofen 600‐800mg TID (max 2400mg/day)
– If heavy or persistent bleeding, check for anemia
• Remove IUC if bleeding is unacceptable to patient
Warnings and Precautions: Bleeding Pattern Alterations
Warnings and Precautions: Bleeding Pattern Alterations (continued)
Warnings and Precautions: Bleeding Pattern Alterations (continued)
Copper T380A For Emergency ContraceptionFor Emergency Contraception
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Cu T for EC: A prospective, multicentre, cohort clinical trial
• Eighteen family planning clinics in China
• 1963 women requesting EC within 120 hours of unprotected intercourse.unprotected intercourse.
• followed at 1, 3 and 12 months after placement of CuT380A.
• No pregnancies occurred prior to or at the first follow‐up visit, making CuT380A 100% effective as emergency contraception in this study.
Wu S, et al. BJOG 2010
• The pregnancy rate over the 12‐month period was 0.23 per 100 women
• 1.5% women experienced a difficult IUD placement
– requiring local anesthesia or prophylactic antibiotics.
Cu T for EC: A prospective, multicentre, cohort clinical trial
requiring local anesthesia or prophylactic antibiotics.
• No uterine perforations occurred.
• The 12‐month postplacement continuation rate was 94.0 per 100 woman‐years.
• CuT380A is a safe and effective method for emergency contraception. The advantages of CuT380A include its ability to provide effective, long‐term contraception.
Wu S, et al. BJOG 2010
A survey of women obtaining EC:are they interested in using the Cu IUD?
• n=941
• 34.0% said they were interested in EC method that was long term, highly effective and reversible.
• Interested women weren’t significantly different• Interested women weren t significantly different from non‐interested women in relation to age, marital status, education, household income, gravidity, previous abortions, previous STIs or relationship status.
• Only 12.3% of these women could also pay $350 or more for the device.
Turok DK, et al. Contraception. 2011
A pilot study of the Cu T380A IUD and Oral Levonorgestrel for EC
• 60% chose oral LNG
• 40% chose the copper IUD.
Turok DK, et al. Contraception. 2010
Underutilization
Why Isn’t the IUC Used More in the US?
• Dearth of trained and willing professionals to place IUCs
• Negative publicity about method in ’70s
42
• Misconceptions by health care providers and the public
Weir. CMAJ 2003Stanwood, NL. Obstet Gynecol 2002Steinauer JE. Family Planning Perspectives 1997
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8
Family PACT Provider Survey
• n=813• Providers who think an IUC should not be inserted in:
– Nullips: 50%– Adolescents: 58%
h h f
43
– Women with a history of ectopic pregnancy: 63%
• Provider’s concern about PID affected willingness to recommend IUC– “A lot” (29%) – “Some” (61%)
Harper C, et. al. OB GYN 2008
IUC Use By Female Ob/Gynsvs. All Women in the U.S.
30
40
50
ulat
ion
ulat
ion
44Population Reference Bureau, 2002.; The Gallup Organization, 2004.
0
10
20
% o
f po
pu%
of
popu
General PopulationGeneral Population
18%18%
0.7%0.7%
Female Ob/Female Ob/GynGyn physiciansphysicians
Correcting Myths
IUCs Do Not Cause PID
• PID incidence for IUC users same as the general population
• Risk is increased only during the first month after placement
46
• Preexisting STI at time of placement, not the IUC itself, increases risk
• No reason to restrict use based on sexual behaviors Svensson L, et al. JAMA. 1984.
Sivin I, et al. Contraception. 1991.Farley T, et al. Lancet. 1992.Grimes DA, Lancet 2000.Hubacher D, et al. Engl J Med 2001
Rate of PID by Duration of IUC Use
6
8
10
Rate per 1000 Rate per 1000
n=n=20,000 women.20,000 women.
47
0
2
4
ppWomanWoman‐‐YearsYears
20 days20 days 21 days 21 days ‐‐ 8 years8 years
Duration of UseDuration of Use
Adapted from Farley T, et al. Lancet. 1992;339:785-788..
Baseline PID risk:Baseline PID risk:11--2 cases /TWY2 cases /TWY
Dalkon Shield
48
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9
Dalkon Shield‐multi‐filament string
49
Fertility Rates in Parous Women After Discontinuation of Contraceptive
ncie
s (%
)nc
ies
(%)
6060
8080
100100
IUCIUC
OCOC
50
Pre
gnan
Pre
gnan
Months After DiscontinuationMonths After Discontinuation
00
2020
4040
00 1212 1818 2424 3030 3636 4242
DiaphragmDiaphragm
Other methodsOther methods
Vessey MP, et al. Br Med J. 1983.Andersson K, et al. Contraception. 1992.Belhadj H, et al. Contraception. 1986.
Ectopic pregnancy risk when contraception fails. A review.
Ectopic Pregnancy Risk When Contraception Fails
Furlong , Reprod Med. 2002
US Medical Eligibility Criteria
CategoryCategory DefinitionDefinition RecommendationRecommendation
1 No restriction in contraceptive use
Use the method
2 Advantages generally outweigh theoretical or proven risks
More than usual follow‐up needed
53
theoretical or proven risks follow up needed
3 Theoretical or proven risks outweigh advantages of the method
Clinical judgment that this patient can safely use
4 The condition represents an unacceptable health risk if the method is used
Do not use the method
Menarche to age 20 US MEC ‐2
Age 20 and older US MEC ‐1
Nulliparity US MEC ‐2
P US MEC 1
54
Parous US MEC ‐1
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Lng‐20 IUC in Nullips
• To evaluate the placement procedure and continuation rates of the LNG‐IUS in nullips
• Placements considered “easy” by 72% of i t ( tl id i )inserters (mostly midwives)
• 5% of patients were dissatisfied
• No perforations
• No pregnancies
Marions L, et al. Eur J Contracept Reprod Health Care. 2011
Lng‐20 IUC in nulliparous women
CONCLUSION:
Our results support the current practice in
Sweden of offering LNG‐IUC routinely to nulliparous women
Marions L, et al. Eur J Contracept Reprod Health Care. 2011
SFP on Nullips
Lyus R, Lohr P, Prage S, Board of the Society of Family Planning. Use of the Mirena LNG‐IUS and Paragard CuT380A intrauterine devices in nulliparous women Contraceptionnulliparous women. Contraception 2010;81:367–71
Contraindications
Both IUC Products:US MEC 2010
Category 4 Category 3Category 3
Distorted uterine cavity
Post‐partum endometritis
Post‐abortion endometritis
M li t GTD ↑ hCG
Postpartum (48h‐4 wk)
Benign GTD with ↓ hCG
Increased risk of STIs
I iti t * 2/3 C ti Malignant GTD or ↑ hCG
Cervical/endometrial cancer
Current GC/CT/purulent cervicitis/PID
− Initiate: 4; Continue: 2
Pelvic TB
− Initiate: 4; Continue: 3
−Initiate*: 2/3; Continue: 2
US Medical Eligibility Criteria 2010
Category 4Category 4 Category 3Category 3
LNGLNG‐‐IUS IUS onlyonly
Current Current breast breast cancercancer
Breast cancer (Breast cancer (>> 5 yrs NED) 5 yrs NED)
Liver tumors, severe cirrhosisLiver tumors, severe cirrhosis
Current MI or anginaCurrent MI or angina
Migraines with auraMigraines with auraMigraines with aura Migraines with aura
AIDS (ARV drug interactions)AIDS (ARV drug interactions)
Complicated transplantComplicated transplant
Lupus with antiLupus with anti‐‐PL antibodyPL antibody
Copper Copper IUC onlyIUC only
Lupus with thrombocytopeniaLupus with thrombocytopenia
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11
Postpartum IUC placementUS MEC 2010
••Vaginal delivery or C/SVaginal delivery or C/S
••BreastBreast‐‐feeding or nonfeeding or non‐‐lactatinglactating
LNGLNG‐‐IUSIUS CuCu‐‐IUDIUD
<10 min after delivery of placenta<10 min after delivery of placenta 2 1<10 min after delivery of placenta<10 min after delivery of placenta 2 1
10 min after delivery of placenta 10 min after delivery of placenta to <4 wksto <4 wks
2 2
>>4 wks post partum4 wks post partum 1 1
Puerperal sepsisPuerperal sepsis 4 4
IUC UsePostpartum
With LactationWith LactationPost abortion
How Is Postpartum IUC Placement Performed?
• IUC placement after vaginal delivery
– Insert IUC within 10 minutes of placental delivery
– Use sponge forceps on cervical lip
– 2nd forceps to place IUC at uterine fundus2 forceps to place IUC at uterine fundus
– Cut string flush with external cervical os
– Trim strings at postpartum visit
How Is Postpartum IUC Placement Performed?
• IUC placement at time of caesarean section
– After delivery of placenta
– Manually place IUC at fundus
t k t i th i– tuck strings thru cervix
– Repair uterus
– Trim strings at postpartum visit
IUC Use During Lactation
• Effectiveness not decreased
• No increased risk of – uterine perforation
– Expulsion
65
Expulsion
• Decreased placement pain
• Reduced rate of removal for bleeding and pain
• LNG comparable to Cu T in breastfeeding parameters
Chi I-C, et al. Contraception. 1989Shaamash AH, et al. Contraception. 2005..
Post Abortion IUC placement(WHO MEC, Cochrane Review)
• No difference in complications for immediate versus delayed placement of an IUC after abortion
• There were no differences in safety or expulsions after placement of an LNG‐IUC compared to Cu‐IUC
66
placement of an LNG IUC compared to Cu IUC
• Expulsion slightly greater when inserted after a 2nd
trimester vs. a 1st trimester abortion
• US Medical Eligibility Criteria 2010
– First trimester abortion: USMEC‐1
– Second trimester abortion: USMEC‐2
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Excellent Time for IUC Placement‐Post Abortion
• Most women ovulate by 21 days post abortion
• Range 8‐37 days
• This is true for:
67
– 1st trimester
– 2nd trimester
– Medical abortion
– Spontaneous abortion
Sober S, et al. Contraception 2010Donnet ML, et al. Clin Endocrinol (Oxf) 1990Cameron IT, et al. Acta Endocrinol 1988R.P. Marrs, et al. Am J Obstet Gynecol 1979
IUC Placement Post Abortion
• Half of abortions are repeat procedures
• 40% of women scheduled for IUC placement did not return for the procedure
• Immediate post‐abortal IUC placement can
68
• Immediate post‐abortal IUC placement can reduce repeat unintended pregnancy
P Bednarek, et al N Engl J Med 2011; 364:2208‐2217M Cremer, et al Contraception 2011; 83:522‐527Stanek AM, et al. Contraception 2009
IUC After Medical Abortion
• Verify patient is no longer pregnant; may place IUC once medical abortion is complete
• 4.1% expulsions
i i 3 h 80%• Continuation rate at 3 months‐ 80%.
Betstadt SJ, et al.Contraception. 2011
Screening Testsand Patient Instructions
Pre‐IUC placement Screening• No routine screening tests
– CT/GC:
• if age <26 and due for annual screening
• if screening is recommended based on risk
71
– Pap test if due
• Any indicated screening test can be done on the day of IUC placement
Sufrin C, et al. Obstetrics and Gynecology 2012Sufrin C, et al. Contraception 2010Intrauterine Contraceptives (IUCs), Family PACT Clinical Practice Alert. 2011
Pre‐placement Guidelines
• Prophylactic antibiotics
–No value for routine administration
–May reduce PID in high prevalence GC/CT sites
• Premedication
72
–NSAID 30‐60 minutes before placement is common, but no effect on pain or discontinuation
–Consider paracervical block if history of cervical os or canal stenosis
Walsh T et al. Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices. IUD Study Group. Lancet. 1998 Apr 4;351(9108):1005‐8.
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Post‐IUC Placement Counseling
• The client should return if
– String cannot be located (use barrier method)
– Symptoms of pregnancy
– Symptoms of infection
73
Symptoms of infection
• Pain, deep dysparunia, fever, foul discharge– Sudden unexplained pelvic pain occurs
– Excessively heavy bleeding
Complications
Uterine Perforation
• More likely to occur in relation to
– Posterior uterine position
– Extreme flexion
– Skill/experience of provider
– placement 2 days‐4 weeks after childbirth
• Typical location is midline at uterine fundus…if so, perforation often is asymptomatic, benign
• Suspect if sounding is much deeper than expected
75
Grimes, et al. Cochrane Library, 2001, Issue 2.Markovitch O, et al. Contraception 2002Caliskan E, et al. The European Journal of Contraception and Reproductive Health Care 2003Harrison-Woolrych M, et al. Contraception 2003;
• If before placement of IUC, stop procedure
• If during placement of IUC, remove IUC
• Monitor for 30 min for excessive bleeding pain
Management of Management of UUterine Perforation terine Perforation
• Monitor for 30 min for excessive bleeding, pain
• Provide alternative method of contraception
• Can insert another device after next menses
76
Prevention of Uterine Perforation
• Why sound the uterus at all?
– Determine the “pathway” to the fundus
– Preliminary dilation of the internal os
– Establish depth to fundus to set flange
– Ensure depth within 6‐10 cm limits
• Bend sound to mimic uterine flexion
• Brace fingertips on speculum to achieve control of force while advancing the sound
• EMB device can be used instead of metal sound
• Open IUC package after sounding completed77
VasovagalVasovagal
• Mechanism– Due to bradycardia + peripheral vasodilation– AKA: non‐cardiogenic syncope, cervical shock
• Association with IUC placement– Syncope in 2% of placements– Convulsions in 1 per 2,000 placements– More likely with
• Pain with cervical manipulation• Nulliparity• Previous episodes of vaso‐vagal fainting• Dehydration or NPO
Grubb BP N Engl J Med 2005
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Presyncopal Signs
• Facial pallor (distinct green hue)
• Yawning
• Pupillary dilatation
• Nervousness
Grubb BP N Engl J Med 2005
Symptoms‐ Presyncopal
• Weakness
• Light‐headedness
• Diaphoresis
• Visual blurring
• Headache
• Nausea
• Feeling warm or cold
Grubb BP N Engl J Med 2005
Vasovagal Prevention
• Good hydration (electrolyte/ sports drink)
• Eat before placement
Grubb BP N Engl J Med 2005
How to Abort a Vasovagal
• Isometric contractions of the extremities
• Intense gripping of the arm, hand, leg and foot muscles
d b i h l h h• No need to bring the legs together or change position– just tense the muscles
• These contractions activate the skeletal‐muscle pump to augment venous return and abort the reflex
Lightheadedness and Syncope:Other Causes
• Hyperventilation– Due to low CO2 levels (respiratory alkalosis)– Heart rate normal or tachycardia– Treat with shallow breaths or re‐breathing bagg g
• Local anesthetic toxicity (if cervical block)– CNS: lightheadedness, restlessness, anxiety, tinnitus, tremor, twitch, perioral numbness, visual changes, seizure, respiratory arrest
– CV: bradycardia, arrythmia, hypotension
83
Bleeding from Tenaculum Site
• Remove tenaculum slowly
• Apply pressure for at least 60 seconds
• Chemical cautery
− Silver nitrate
84
− Silver nitrate
− Monsel’s solution
• Suturing very rarely is necessary
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15
IUCs: Management of Cramping
• Mild: recommend NSAIDs
• Severe or prolonged
– Examine for partial expulsion, perforation, or PID
– Remove IUD if severe cramping is unrelated to menses or unacceptableto patient
Genital Tract InfectionsGenital Tract Infections
• If cervical or vaginal infection diagnosed– IUC removal not necessary– Treat infection– Counsel re: prevention of STI transmission
• If PID diagnosed
86
If PID diagnosed– IUC removal usually not necessary– Treat infection– Recommendations to remove IUC are not evidence‐based
– Consider removal if no improvement 48‐72 hours after starting treatment
Penney G. J Fam Plann Reprod Health Care. 2004WHO. Selected Practice Recommendations for Contraceptive Use. 2004
Actinomyces‐Like Organisms (ALO)
• Actinomyces israelii has characteristics of both bacteria and fungus; part of GI flora
• May asymptomatically colonize the frame of the IUC, which in itself is not dangerous
• Very small percentage of women with IUC +
87
y p gactinomyces will develop pelvic actinomycosis– Presentation is similar to severe PID
• Women with ALO on Pap smear– Should be examined to exclude PID– If none, don’t treat actinomyces or remove IUC
IUC Expulsion
• Occurs in 1‐10% IUC placements within first year• Risk of expulsion related to
– Provider’s skill at fundal placement – Age, parity, BMI,uterine configurationTime since placement (↑ within first 6 mos)
88
– Time since placement (↑ within first 6 mos)– Timing of placement (menses, postpartum, post‐abortion)
• Asymptomatic expulsion may present with pregnancy• Partial expulsion may present with
– Pelvic pain, cramps, intermenstrual bleeding– Pregnancy
P Bednarek, et al N Engl J Med 2011; 364:2208‐2217M Cremer, et al Contraception 2011; 83:522‐527
Missing IUC String: Diagnosis • Possibilities…
– Expulsion, pregnancy, embedment, translocation
• Initial management
– Probe for strings in cervical canal
89
Probe for strings in cervical canal
Cytology brush to tease from canal
Endocervical speculum or forceps
– Rule out pregnancy
– Prescribe back‐up contraceptive method until intrauterine location is confirmed
Prabhakaran S. et, al. Contraception.2011
Missing IUC String•No IUC string in canal•Pregnancy test negative
Ultrasound
Desires removal
Desires retention
Ultrasound Flat plate of abdomenOR
90
In Situ
Extract ± ultrasound guidance
In Situ Absent
Flat plate of abdomen
Refer for hysteroscopy
Present
Perforated
Absent
Expelled
AbsentAbsent Present
Ultrasound
Absent
Perforated
In Situ
Absent
Extracted
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Missing IUC String: Treatment
•• In situ (intrauterine) placement: desires continuationIn situ (intrauterine) placement: desires continuation
–– Leave in place for remainder of IUC lifespanLeave in place for remainder of IUC lifespan
•• In situ placement: desires removalIn situ placement: desires removal
–– Use straight or “alligator” Use straight or “alligator” forcepforcep, , ++ simultaneous simultaneous real time pelvic ultrasoundreal time pelvic ultrasound
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real time pelvic ultrasound real time pelvic ultrasound
–– Crochet hook best for circular IUCs; less helpful with Crochet hook best for circular IUCs; less helpful with TT‐‐shaped IUCsshaped IUCs
–– If unsuccessful, extract via operative hysteroscopyIf unsuccessful, extract via operative hysteroscopy
•• Translocation (IUC in peritoneal cavity)Translocation (IUC in peritoneal cavity)
–– Extract via operative laparoscopyExtract via operative laparoscopy
Pregnancy With IUC In Situ
•• Determine site of pregnancy (IUP or ectopic)Determine site of pregnancy (IUP or ectopic)•• If intrauterine pregnancy confirmedIf intrauterine pregnancy confirmed
–– Termination planned: await procedureTermination planned: await procedure–– Continue pregnancy: remove IUC if strings visible Continue pregnancy: remove IUC if strings visible
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p g y gp g y g–– Removal decreases risk of spontaneous abortion, Removal decreases risk of spontaneous abortion, premature deliverypremature delivery
•• Retention of IUC (if strings not visible)Retention of IUC (if strings not visible)–– Increase surveillance for SAB, preIncrease surveillance for SAB, pre‐‐term birthterm birth–– No greater risk of birth defects (extraNo greater risk of birth defects (extra‐‐amniotic) amniotic)
LNG‐IUC Isn’t at the Fundus?
• There can be migration within the uterine cavity• A LNG‐IUC in lower uterine segment is still effective• Removal of the device is necessary only if
– A portion of it protrudes from the cervix, or
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p p ,– There is excessive cramping with a low‐lying IUC
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What Should I Do if the Cu 380A Isn’t at the Fundus?
• Fundal placement is necessary for optimal efficacy• A copper IUC in the lower uterine segment is less effective
• Removal of the device and re‐insertion of a new
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• Removal of the device and re‐insertion of a new device at the fundus is best to insure efficacy
• Do not “push” a partially expelled or low lying device up to the fundus
Perimenopause&
Menopause
IUC Perimenopause
• Leave in place until through transition• LNG IUC can prevent perimenopausal bleeding• Consider leaving LNG IUC in for HT• OK not to replace if slightly overdue
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OK not to replace if slightly overdue
Wan YL, Holland C. The efficacy of levonorgestrel intrauterine systems for endometrial protection: a systematic review. Climacteric. 2011;14(6):622‐32.
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IUC Post Menopause?
• Strings seen: remove• Consider placing LNG IUC for HT
– Less systemic absorption of progestin
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Wan YL, Holland C. The efficacy of levonorgestrel intrauterine systems for endometrial protection: a systematic review. Climacteric. 2011;14(6):622‐32.
Placement Practicum
IUC Placement Practicum
Placement of Cu‐T IUC
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Steps for IUC Placement
• Perform bimanual pelvic exam to determine anterior or retro‐ flexion
• Inspect cervix for mucopus• Cleanse cervix with antiseptic• Use of sterile gloves vs. “no‐touch” technique
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• Apply tenaculum– Routine vs. selective local anesthetic injection– Hold hand in palm‐up position– “Squeeze” closed; don’t “snap” ratchet– Horizontal or vertical application (purchase)
• Routine vs. selective use of cervical block
Steps for IUC Placement
• Sound the uterus
– Purposes
Determine the “pathway” to the fundus
Preliminary dilation of the internal os
Establish depth to fundus to set flange
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Establish depth to fundus to set flangeEnsure depth within 6‐10 cm limits
– Bend sound to mimic uterine flexion
– Brace fingertips on speculum to achieve control of force while advancing the sound
– EMS* device can be used instead of metal sound
EMS*: endometrial samplingEMS*: endometrial sampling
ParaGard Placement*
• Load arms into inserter
102* Excerpted from package insert* Excerpted from package insert
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ParaGard Placement
• Load arms into inserter
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ParaGardPlacement
• Advance insertion tube to fundus
• Fundal resistance
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should be coincident with the marker reaching the exocervix
ParaGardPlacement
• Pull back on inserter tube while holding white rod steady to
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steady to deposit IUC in cavity
ParaGardPlacement
• Push inserter tube until resistance to seat the arms of
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seat the arms of the IUC in the fundus
ParaGardPlacement
• Withdraw the white rod while holding
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holding inserter tube steady
ParaGardPlacement
•• Slowly withdraw Slowly withdraw the inserter from the inserter from the cervical canalthe cervical canal
•• Use inserter tubeUse inserter tube
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•• Use inserter tube Use inserter tube as a guide for as a guide for cutting the cutting the stringsstrings
•• Trim threads to 3Trim threads to 3‐‐4 cm.4 cm.
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IUC Placement Practicum
• Placement of LNG‐IUC 20 Mirena
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Mirena: The InserterMirena: The Inserter
110“Never let go of the Slider!!”“Never let go of the Slider!!”
1. Open sterile package2. Release the threads3. Make sure the slider is
Steps for Steps for MirenaMirenaPlacement*Placement*
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….in the furthest position ….away from you4. Check that the arms of
the IUC are horizontal
* Excerpted from package insert* Excerpted from package insert
5.5. Pull on both threads Pull on both threads to draw IUC system to draw IUC system into insertion tubeinto insertion tube
Steps for Steps for MirenaMirenaPlacement*Placement*
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6.6. Both knobs at ends of Both knobs at ends of IUC arms are now IUC arms are now within the inserterwithin the inserter
Steps for Steps for MirenaMirena Placement*Placement*
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7. Fix threads tightly into the cleft at near end 7. Fix threads tightly into the cleft at near end of inserter shaftof inserter shaft
8. Set upper edge of 8. Set upper edge of movable green flange movable green flange to the depth of uterine to the depth of uterine
dd
Steps for Steps for MirenaMirena Placement*Placement*
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soundsound
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9. Hold slider with forefinger, or thumb, firmly in furthermost position
Steps for Steps for MirenaMirena Placement*Placement*
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10. Move inserter thru cervical canal until flange is about 1.5- 2.0 cm from cervix- allows sufficient spacefor IUC arms to open
11. While holding 11. While holding inserter steady, inserter steady, release arms of IUC release arms of IUC by pulling slider by pulling slider back until it reaches back until it reaches the raised mark on the raised mark on
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inserterinserter
12. Push inserter 12. Push inserter gently until flange gently until flange touches cervix.touches cervix.Th IUC h ld bTh IUC h ld b
Steps for Steps for MirenaMirena Placement*Placement*
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The IUC should be The IUC should be in in fundalfundal positionposition
13. Pull down on 13. Pull down on slider all the way; slider all the way; threads will threads will uncleatuncleatautomatically and automatically and release IUC system release IUC system
Steps for Steps for MirenaMirena Placement*Placement*
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yy
Double check that Double check that the strings are the strings are uncleateduncleated before before withdrawing the withdrawing the inserter inserter
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• Reduce expulsion rate by waiting for strings to be released from cleft before withdrawal
OBG Management | Vol. 21 No. 2 | February 2009
14. Remove inserter and 14. Remove inserter and cut threads about cut threads about 44--5 cm 5 cm from from cervixcervix
Steps for Steps for MirenaMirenaPlacement*Placement*
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Use inserter tube as a Use inserter tube as a guide for cutting the guide for cutting the stringsstrings
15. Measure and record in 15. Measure and record in patient’s patient’s chartchart
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IUC Placement Practicum
• Placement of LNG‐IUC 13.5 Skyla
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Skyla™ Inserter (continued)
How to Reload the Reloadable Demonstration Inserter Insertion Procedure
Insertion Procedure Insertion Procedure
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Insertion Procedure Insertion Procedure
Insertion Procedure Insertion Procedure
Insertion Procedure
Difficult IUC PlacementDifficult IUC Placement
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Difficulty SoundingDifficulty Sounding
• Use greater outward traction on the tenaculum to minimize canal‐to‐endometrial cavity angulation
• Place paracervical or intracervical block to relax cervical smooth muscle and reduce pain
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cervical smooth muscle and reduce pain
• Use os finder device, if available
• Dilate internal os with metal dilators to #13F (4.1 mm)
• If unsuccessful, return at a later date with use of misoprostol cervical priming
Os Finder Device Os Finder Device
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Cervical Os Finders (Disposable Box/25) $ 49.00Cervical Os Finders (Disposable Box/25) $ 49.00Cervical Os Finder Set (Reusable Set of 3) $ 69.00Cervical Os Finder Set (Reusable Set of 3) $ 69.00Cervical Os Finders (Disposable Box/25) $ 49.00Cervical Os Finders (Disposable Box/25) $ 49.00Cervical Os Finder Set (Reusable Set of 3) $ 69.00Cervical Os Finder Set (Reusable Set of 3) $ 69.00
Pratt DilatorsPratt Dilators
Paracervical Block
• Target is uterosacral ligaments• Inject at reflection of cervico‐vaginal epithelium• 2 (5, 7 o’cl) or 4 sites (4,5,7,8 o’cl) submucosallyto depth of 5 mm
• Use spinal needle or 25g, 1 ½” needle + extender
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p g• Moore‐Graves speculum allows for more movement
• Tips – Start with ½‐1 cc. at tenaculum site– Disguise pain of needle insertion with cough– WAIT 1‐2 minutes for set up before procedure
Paracervical Block
XX
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XX XX 5 o’clock5 o’clock7 o’clock7 o’clock
Paracervical Block
XX
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XX 5 o’clock5 o’clock7 o’clock7 o’clockXX XXXX
6 o’clock6 o’clock
Intra‐cervical Block
• Targets the paracervical nerve plexus• 1 ½ inch 25g needle with 12 cc “finger lock” syringe
• Inject ½‐ 1 cc. local anesthetic at 12 o’clock, then apply tenaculum
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pp y• Angulate needle at the hub to 45o lateral direction
• At 3 or 9, insert needle into cervix to the hub 1 cm lateral to external os, aspirate
• Inject 4 cc of local, then last 1 cc while withdrawing
• Rotate barrel 180o, then inject opposite side
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Intracervical Block
XX
XX XX
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5 o’clock7 o’clock7 o’clock
XX
6 o’clock
XX9 o’clock9 o’clock 3 o’clock3 o’clock
Prophylactic Misoprostol in Nulliparous Women
• Pain scores no different in the two groups
• Increase in preinsertion side effects
• In one trial:In one trial:– Insertion considered easier– “Misoprostol facilitates IUD placement and reduces the number of difficult and failed attempts of placements in women with a narrow cervical canal”
Saav I et. al., Human Reproduction 2007; 22, (10): 2647Shaefer E et al, Contraception 2010Edelman AB, et al. Contraception. 2011
Tips for IUC Placement in Women with Fibroids
• Determine fibroid location by ultrasound
– Fundal fibroids (intramural, sub‐serous) that do not distort uterine cavity do not preclude IUC use
– Large sub‐mucous fibroids especially in lowerLarge sub mucous fibroids, especially in lower uterine segment, contraindicate IUC use
– Evaluate for other pathology, e.g., polyp
• Ultrasound guidance may facilitate safe placement
• No data on efficacy, but probably not compromised with LNG‐IUS or with Cu‐T if fundal placement
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FPACT Rules, Billing & Coding
Family PACT IUC Policy: Purchase and Records
• IUCs:– FDA‐approved devices, labeled for US use, and obtained from FDA approved distributors
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• Providers:– Record the lot number in the med record
– Keep a log of all IUCs placed for > 3 yrs
– Maintain invoices > 3 years
• Patients:– Provided with the dates of placement and expiration
Billing Instructions for IUCs Primary Diagnosis Codes
• S401: Evaluation prior to initiation of the method, whether or not the IUC is inserted that day – Use S401 when performing the placement of the first IUC for this client
• S402: Maintain adherence and surveillance for a
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S402: Maintain adherence and surveillance for a current user of an IUC, whether or not the client is new to the provider – Use S402 when replacing an IUC with another of the same type or a different type
– Both placement and removal may be billed on the same date of service
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• placement
– CPT 58300: placement of IUC
– 58300‐ZM: placement supplies
– Kit: X1522 (ParaGard) or X1532 (Mirena)
Billing Instructions for IUCsBilling Instructions for IUCsplacement placement or Removal Proceduresor Removal Procedures
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Kit: X1522 (ParaGard) or X1532 (Mirena)
– E&C: contraceptive counseling visit
• Removal
– CPT 58301: Removal of IUC
– 58301‐ZM: Removal supplies
– E&C: contraceptive counseling visit
IUC Complication Coverage
• New Family PACT benefits for IUCs– CPT‐4 code 76857: Ultrasound, pelvic (nonobstetric)
– CPT‐4 code 76830: Ultrasound, transvaginal– Billing requirements for code 74000 are revised
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• 3 codes billed in conjunction with primary diagnosis code S402 and secondary diagnosis code V45.51 (intrauterine contraceptive device). A Treatment Authorization Request is not required.
• S4032 will no longer be a valid Family PACT PDC effective for dates of service on or after June 1, 2011.
IUC Complication Coverage • IUC complications
– S403 Vaso‐vagal episode– S4031 Pelvic infection (secondary to IUC)– S4032 “Missing” IUC‐ no longer a valid code– S4033 Perforated or translocated IUC
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– S4033 Perforated or translocated IUC• Covered complication services include
– Hysteroscopy, dilation and curettage– Laparoscopy/ laparotomy
• All complication services must be approved by TAR• Consult PPBI @ familypact.org
Take Home the “IUCs”Take Home the “IUCs”
• Keep one in your lab coat
• One in each room
• Give them to your patient to hold, feel and l i h hil di i h h dplay with while discussing the method
• Show her how to feel the threads with it