Introducing the 2010 US Introducing the 2010 US Medical Medical Eligibility CriteriaEligibility Criteria:: An Evidenced An Evidenced Based Tool for Determining Safe Based Tool for Determining Safe Use of Contraception with Chronic Use of Contraception with Chronic and Other Medical Conditionsand Other Medical Conditions

Womens Health in Primary CareWomens Health in Primary CareOrlando Florida March 2011Orlando Florida March 2011Norma Jo Waxman MDNorma Jo Waxman MDPrivate Practice, San FranciscoPrivate Practice, San FranciscoAssociate Professor of Family and Community MedicineAssociate Professor of Family and Community MedicineUniversity of California San FranciscoUniversity of California San Francisconjwaxman@fcm.ucsf.edunjwaxman@fcm.ucsf.edu

ObjectivesObjectivesAt the end of the talk participants will be able to:At the end of the talk participants will be able to:

Utilize the CDC Medical Eligibility Criteria to find safe Utilize the CDC Medical Eligibility Criteria to find safe contraceptive options for women with medical contraceptive options for women with medical problems.problems.

Explain the safety of hormonal contraceptionExplain the safety of hormonal contraception

Remember to think about contraception when Remember to think about contraception when prescribing FDA Category D or X medications prescribing FDA Category D or X medications (dangerous in pregnancy) (dangerous in pregnancy)

WHO Medical Eligibility WHO Medical Eligibility CriteriaCriteria

Unique contributionsUnique contributions– Evidence basedEvidence based– Comprehensive, up-to-dateComprehensive, up-to-date– Only “accepted” guideline of its kindOnly “accepted” guideline of its kind

Considerations for use in USConsiderations for use in US– WHO Criteria were written to include “lowest WHO Criteria were written to include “lowest

common denominator” health systemscommon denominator” health systems– Conservative for use in the USConservative for use in the US– Consider as “tools not rules”Consider as “tools not rules”

WHO WHO Medical Eligibility Medical Eligibility CriteriaCriteria for Contraceptive Use for Contraceptive Use – 4– 4rdrd editioedition - 2009n - 2009 – www.who.int/reproductive-health/www.who.int/reproductive-health/

publications/mec/publications/mec/

WHO Medical Eligibility CriteriaWHO Medical Eligibility Criteria More evidence based than package More evidence based than package insertinsert

ClassificationClassification

11 Use method in any circumstancesUse method in any circumstances

22 Generally use the methodGenerally use the method

33 Use of method not usually recommended Use of method not usually recommended unless other more appropriate methods are not unless other more appropriate methods are not availableavailable

44 Method not to be usedMethod not to be used

Medical Eligibility Criteria For Contraceptive Use. Third Edition. WHO, 2004.

WHO Medical Eligibility WHO Medical Eligibility CriteriaCriteria

Combined hormonal contraceptives (CHC)Combined hormonal contraceptives (CHC)– COC: Combined oral contraceptivesCOC: Combined oral contraceptives– CIC: Combined injectable contraceptivesCIC: Combined injectable contraceptives– P/R: Patch and Vaginal RingP/R: Patch and Vaginal Ring

Progestin only contraceptivesProgestin only contraceptives– POP: Progestin only pillsPOP: Progestin only pills– DMPA: Depo-MPA DMPA: Depo-MPA – IMPLT: Implanon contraceptive implantIMPLT: Implanon contraceptive implant

Intrauterine contraceptivesIntrauterine contraceptives– Cu-IUD: Copper T-380 IUDCu-IUD: Copper T-380 IUD– LNG-IUD: Levonorgestrel IUSLNG-IUD: Levonorgestrel IUS

US MEC: ScopeUS MEC: Scope Current WHO MEC > 1800 recommendationsCurrent WHO MEC > 1800 recommendations

No need to change majority of recommendationsNo need to change majority of recommendations– Science the same & widely used around the worldScience the same & widely used around the world

CDC accepted majority of WHO CDC accepted majority of WHO recommendationsrecommendations

Exceptions: existing WHO recommendations that Exceptions: existing WHO recommendations that needed to be adapted for US contextneeded to be adapted for US context

A few additional areas A few additional areas

http://www.reproductiveaccess.org/contraception/downloads/WHO_Chart.pdf

CDC MEC GuidelinesCDC MEC Guidelines

www.reproductiveaccess.orgwww.reproductiveaccess.org

Go to “providers” then under “clinical Go to “providers” then under “clinical resources” you will see MEC resources” you will see MEC guidelines.guidelines.

Available in Word or PDFAvailable in Word or PDF Link to the comprehensive MEC listLink to the comprehensive MEC list

Medical Benefits of Hormonal Medical Benefits of Hormonal ContraceptionContraception

Menstrual related health benefitsMenstrual related health benefits::– Decreased dysmenorrheaDecreased dysmenorrhea– Decreased menstrual blood loss Decreased menstrual blood loss – Reduces menstrual related PMS symptomsReduces menstrual related PMS symptoms

Improves acne and hirsutism Improves acne and hirsutism Reduction of:Reduction of:

– Ectopic pregnanciesEctopic pregnancies– Benign breast conditionsBenign breast conditions– Perimenopausal sxs, DUB, PCOS, EndometriosisPerimenopausal sxs, DUB, PCOS, Endometriosis– PIDPID– Anemia Anemia

Medical Benefits of Hormonal Medical Benefits of Hormonal ContraceptionContraception

OC users reduce risk of ovarian Ca by 40%OC users reduce risk of ovarian Ca by 40%11, , and by 80% after 10 yrs and by 80% after 10 yrs22

OC reduces risk of endometrial CA by up to OC reduces risk of endometrial CA by up to 40%40%33

No increase risk of Breast CA in OC usersNo increase risk of Breast CA in OC users4,54,5

1. Vessey et al Br J Cancer 1995. 2. Rosenberg et al Am J Epidmiol 1994 3. JAMA 1987:257(6)4. 4. Marchbanks et al NEJM 2002;346:2025-2032 5. Hannaford et al BMJ 2007; 335 : 651

Risk Misperception & the Risk Misperception & the PatientPatient

“…“…incorrect perceptions of excess incorrect perceptions of excess risk of contraceptive products may risk of contraceptive products may lead women to use them less than lead women to use them less than effectively or not at all.”effectively or not at all.”

““Throw away the package insert”Throw away the package insert”““2 times a rare event is still a rare 2 times a rare event is still a rare event”event”

Gardner J, Miller L. J Womens Health 2005

David Grimes MD, September 2006

Risk Comparisons Risk Comparisons (slide credit: (slide credit: Association of Reproductive Health Professionals)Association of Reproductive Health Professionals)

SkydivingSkydiving 100 100

Driving Driving 20 20

PregnancyPregnancy 11.5 11.5

Riding a bicycleRiding a bicycle 0.8 0.8

Airplane crashAirplane crash 0.4 0.4

Using OC*Using OC* 0.06 0.06* Nonsmoker, under age 35

Trussell J, Jordan B. Contraception in press. Chang J, et al. MMWR 2003. Harvard Center for Risk Analysis 2006. Bennett P. In: Risk Communication and Public Health 1999.

Annual Risk of Death (per 100,000)Annual Risk of Death (per 100,000)

15

LARC is safe when Estrogen containing LARC is safe when Estrogen containing hormonal methods are contraindicatedhormonal methods are contraindicated

WHO Medical Eligibility Criteria for Contraceptive Use. In Family Planning. 2007.

CDC US Medical Eligibility for Initiating ContraceptionCDC US Medical Eligibility for Initiating Contraception

ConditionCondition Copper Copper IUDIUD LNG-IUSLNG-IUS ImplantImplant

Breastfeeding Breastfeeding (>6 weeks postpartum)(>6 weeks postpartum) 11 11 11

SmokingSmoking 11 11 11

HypertensionHypertension <159 / <99<159 / <99 11 11 11

>160 / >100 >160 / >100 11 22 22

+ Vascular + Vascular diseasedisease 11 22 22

MigrainesMigraines 11 22 22

DiabetesDiabetes mellitusmellitus 11 22 22

Liver diseaseLiver disease Mild/severeMild/severeCirrhosis Cirrhosis 11 1/31/3 1/31/3

Malig TumorsMalig Tumors 11 33 33

Active hepatitisActive hepatitis 11 11 11

Case Study: Case Study: BreastfeedingBreastfeeding

A 30 y.o. female is post partum day #2, ready A 30 y.o. female is post partum day #2, ready to be discharged from hospital, and desires to be discharged from hospital, and desires contraception. She plans to breastfeed. contraception. She plans to breastfeed.

Which hormonal methods are safe for her to Which hormonal methods are safe for her to use?use?

Post-partum Post-partum Contraception:Contraception: General Considerations General Considerations

Goals of postpartum (pp) contraception Goals of postpartum (pp) contraception – Efficacy: limit family size, plan birth spacingEfficacy: limit family size, plan birth spacing– Support successful breastfeeding Support successful breastfeeding – In GDMs, avoid conversion to frank diabetes In GDMs, avoid conversion to frank diabetes

Most women begin intercourse within 1-2 Most women begin intercourse within 1-2 monthsmonths– 60-70% are sexually active by 6 weeks pp60-70% are sexually active by 6 weeks pp– 4% abstinent by the end of the 124% abstinent by the end of the 12thth pp week pp week

Post-partum Ovulation Post-partum Ovulation PatternsPatterns

Resumption of ovulation in Resumption of ovulation in non-lactatingnon-lactating womenwomen– Ovulate in 6-7 wks (median= 45 days)Ovulate in 6-7 wks (median= 45 days)– None before 25 days from the deliveryNone before 25 days from the delivery

Resumption of ovulation in Resumption of ovulation in lactatinglactating women women – Intensity, frequency, duration of sucklingIntensity, frequency, duration of suckling– Time elapsed since deliveryTime elapsed since delivery– Maternal nutritional stateMaternal nutritional state– Rate of weaning: rapid > gradual weaningRate of weaning: rapid > gradual weaning– Introduction of supplementary feeding Introduction of supplementary feeding

(ovulation usually begins 6 weeks later)(ovulation usually begins 6 weeks later)

Contraception and Contraception and BreastfeedingBreastfeeding

Two considerationsTwo considerations– Potential effect on breastfeeding performance Potential effect on breastfeeding performance

(initiation, maintenance, duration of lactation (initiation, maintenance, duration of lactation and need for supplementation)and need for supplementation)

– Potential effect on infant health and Potential effect on infant health and development (infant weight, infant length, development (infant weight, infant length, physical findings, health problems, and physical findings, health problems, and psychomotor development)psychomotor development)

Breastfeeding- Breastfeeding- EvidenceEvidence

Combined hormonal methodsCombined hormonal methods– 8 studies of combined hormonal methods8 studies of combined hormonal methods– 4 studies reported decreased duration and 4 studies reported decreased duration and

higher rates of supplemental feedinghigher rates of supplemental feeding– 1 study no difference in breastfeeding 1 study no difference in breastfeeding

performanceperformance– No adverse effect on infant growth, health, or No adverse effect on infant growth, health, or

development through 8 years of agedevelopment through 8 years of age

Breastfeeding- EvidenceBreastfeeding- Evidence

Progestin-only methodsProgestin-only methods– 43 Studies43 Studies– POPS, DMPA, implants, and LNG-IUDPOPS, DMPA, implants, and LNG-IUD– No adverse effect on breastfeeding No adverse effect on breastfeeding

performance performance – No adverse effect on infant growth, health, No adverse effect on infant growth, health,

or development through 6 years of ageor development through 6 years of age

Post-partum OC's: Maternal Post-partum OC's: Maternal RiskRisk

Changes in maternal clotting factors persist Changes in maternal clotting factors persist for 4 weeks after term deliveryfor 4 weeks after term delivery– Increased VTE risk up to 4 week post-partumIncreased VTE risk up to 4 week post-partum

Coagulation effects of pregnancy Coagulation effects of pregnancy and and OC's OC's may increase risk of VTEmay increase risk of VTE– However, VTE rates have not been studied in However, VTE rates have not been studied in

postpartum low-dose OC users vs. controlspostpartum low-dose OC users vs. controls

Greater VTE risks not expected with POPs, Greater VTE risks not expected with POPs, since no change in clotting factorssince no change in clotting factors

Breastfeeding- GapsBreastfeeding- Gaps

Most observational studies- need RCTMost observational studies- need RCT Timing of initiation of contraceptive Timing of initiation of contraceptive

methodsmethods No consistent definitions of breastfeedingNo consistent definitions of breastfeeding No consensus on outcome measures for No consensus on outcome measures for

breastfeeding or infant healthbreastfeeding or infant health No inclusion of ill or premature infantsNo inclusion of ill or premature infants Need longer follow upNeed longer follow up

2009 2009 WHOWHO Medical Eligibility Medical Eligibility CriteriaCriteriaPost-Partum BreastfeedingPost-Partum Breastfeeding

CONDITIONCONDITION OC/P/ROC/P/R POPPOP DMPADMPA ImplanImplantt

< 6 weeks< 6 weeks 44 33 33 336 weeks-6 weeks-6 months6 months

33 11 11 11

> 6 months> 6 months 22 11 11 11

2010 2010 USUS Medical Medical Eligibility Eligibility CriteriaCriteria Post-partum BreastfeedingPost-partum Breastfeeding

CONDITIONCONDITION OC/P/ROC/P/R POPPOP DMPADMPA ImplantImplant

<1 month<1 monthpostpartumpostpartum

33 22 22 22

1 month to 61 month to 6monthsmonths

22 11 11 11

> 6 months> 6 monthspostpartumpostpartum

11 11 11 11

Post-partum CHC: Clinical Post-partum CHC: Clinical GuidelinesGuidelines

Non-nursing womenNon-nursing women– CHC starting 4 weeks postpartumCHC starting 4 weeks postpartum

Nursing womenNursing women– Conservative approachConservative approach

First 3 months: avoid CHCFirst 3 months: avoid CHC >> 3 mo or weaned: switch to CHC 3 mo or weaned: switch to CHC

– Liberal approachLiberal approach CHC once lactation established ( CHC once lactation established ( >> 4 wks) 4 wks)

If COCs used, use 20 mcg estrogen doseIf COCs used, use 20 mcg estrogen dose

Post-partum Long-acting Post-partum Long-acting ProgestinsProgestins

DMPADMPA– Mildly lactogenic; no change in milk contentMildly lactogenic; no change in milk content

ImplantImplant (Implanon, Norplant studies) (Implanon, Norplant studies)– No effect on milk volume, content, or growthNo effect on milk volume, content, or growth

Administration before hospital dischargeAdministration before hospital discharge– AdvantageAdvantage

Protected if post-partum visit is missedProtected if post-partum visit is missed

– DisadvantagesDisadvantages Unnecessary for first 4 weeksUnnecessary for first 4 weeks Anatomic bleeding vs. drug side effectAnatomic bleeding vs. drug side effect

2009 2009 WHOWHO MEC MEC: : Postpartum IUC InsertionPostpartum IUC Insertion

LNG-IUSLNG-IUS Cu-IUDCu-IUD CommentComment< 48 hours < 48 hours 33 22 Evidence: There was Evidence: There was

some increase in some increase in expulsion rates with expulsion rates with immediate insertion immediate insertion compared to delayed compared to delayed postpartum insertion postpartum insertion and interval insertion.and interval insertion.

48 hours to 48 hours to 4 weeks4 weeks

33 33

> 4 weeks > 4 weeks 11 11

EndometritisEndometritis 44 44

Guidelines are identical in lactating and non-lactating womenGuidelines are identical in lactating and non-lactating women Insert IUC within 15 minutes of placental deliveryInsert IUC within 15 minutes of placental delivery Use sponge forceps on cervical lip; 2Use sponge forceps on cervical lip; 2ndnd sponge forceps to insert sponge forceps to insert Cut string flush with external cervical osCut string flush with external cervical os

2010 2010 US US MECMEC: : Postpartum IUC InsertionPostpartum IUC Insertion

Postpartum (BF or non-BF Postpartum (BF or non-BF women) including C/Swomen) including C/S

LNG-IUSLNG-IUS Cu-IUDCu-IUD

<10 min after delivery of <10 min after delivery of placentaplacenta

22 11

10 min after delivery of 10 min after delivery of placenta to <4 wksplacenta to <4 wks

22 22

>>4 wks post partum4 wks post partum 11 11Puerperal sepsisPuerperal sepsis 44 44

Case Study: Case Study: BreastfeedingBreastfeeding

30 y.o. Post partum desires 30 y.o. Post partum desires contraception. Plans to breastfeed contraception. Plans to breastfeed

Which hormonal methods can she Which hormonal methods can she use?use?

Answer Answer POPs, DMPA, implants, LNG-IUD POPs, DMPA, implants, LNG-IUD

(Category 2) (Category 2) She should generally not use CHCs She should generally not use CHCs

(Category 3)(Category 3)

Case Study: Diabetes Case Study: Diabetes MellitusMellitus

32 y.o. woman G3P232 y.o. woman G3P2 Gestational DM with Gestational DM with

both pregnanciesboth pregnancies DM type 2 since last DM type 2 since last

birth 2 years agobirth 2 years ago Well controlled on Well controlled on

metforminmetformin What type of What type of

contraception can she contraception can she use?use?

Diabetes and ContraceptionDiabetes and ContraceptionOC/P/ROC/P/R POPPOP DMPADMPA IMPLIMPL LNG-LNG-

IUDIUDCu-Cu-IUDIUD

DMDM GestationGestational DM in al DM in past past

11 11 11 11 11 11

DM w/o DM w/o vascular vascular disease disease

22 22 22 22 22 11

DM w/ DM w/ end-organ end-organ damage damage or > 20 or > 20 yrs yrs duration duration

33 22 33 22 22 11

Diabetes and Diabetes and ContraceptionContraception

Birth defects occur in 5-8% of Birth defects occur in 5-8% of children born to US women with children born to US women with diabetesdiabetes– Double the general pop rateDouble the general pop rate

2/3 of women with diabetes have 2/3 of women with diabetes have unintended pregnanciesunintended pregnancies

Diabetic women are ½ as likely to Diabetic women are ½ as likely to receive contraceptive Rx or receive contraceptive Rx or counselingcounseling

Category D or X medicationsCategory D or X medications

Use of Class D and X Rx common Use of Class D and X Rx common Anxiolytics, anticonvulsants, statins, Anxiolytics, anticonvulsants, statins, doxycycline, warfarin, DHE and ergotaminedoxycycline, warfarin, DHE and ergotamine

– 1 of every 25 Rx1 of every 25 Rx– 1 of every 13 visits1 of every 13 visits– 1 of every 6 women!1 of every 6 women!

Contraceptive counseling < 20%Contraceptive counseling < 20%11 to 50 % to 50 %22 of visits of visits documenting potential teratogen use or RXdocumenting potential teratogen use or RX

1. Schwarz EB et al. Prescription of teratogenic medications in US ambulatory practices. Am J Med. 2005 Nov;118 (11): 1240-1249 2. Schwarz EB et al. Documentation of Contraception and Pregnancy When Prescribing Potentially Teratogenic Medications for Reproductive-Age Women. Ann Intern Med. 2007; 147(6): 370–376.

Case Study: h/o Deep Vein Case Study: h/o Deep Vein ThrombosisThrombosis

24 year old G24 year old G11PP00 woman requests Pill woman requests Pill or Patchor Patch

h/o DVT right calf at 18 years oldh/o DVT right calf at 18 years old Hospitalized 1 week: “shots” for 5 Hospitalized 1 week: “shots” for 5

days; then “pills” for 3 monthsdays; then “pills” for 3 months Mother “had blood clot go to her Mother “had blood clot go to her

lungs” during pregnancylungs” during pregnancy Healthy non-smoker; stable Healthy non-smoker; stable

relationship; intercourse once or relationship; intercourse once or twice a weektwice a week

Risk Factors for DVT and Risk Factors for DVT and VTEVTE Age (especially >40 years old)Age (especially >40 years old) Pregnancy, post-partum period (< 3-4 Pregnancy, post-partum period (< 3-4

weeks)weeks) ObesityObesity Immobilization with venous stasisImmobilization with venous stasis Personal history of DVT or VTEPersonal history of DVT or VTE Family history (inherited clotting disorder) Family history (inherited clotting disorder)

– Factor V Leiden mutation (Protein C resistance)Factor V Leiden mutation (Protein C resistance)– Protein S, Protein C deficiencyProtein S, Protein C deficiency

Venous Thrombosis and Venous Thrombosis and CHCCHC

▲▲DVT rates with increasing dose of estrogenDVT rates with increasing dose of estrogen OC and OrthoEvra have similar DVT risk (Jick, 2006)OC and OrthoEvra have similar DVT risk (Jick, 2006)

– NGM OCs: NGM OCs: 4.2/10,000 women/year4.2/10,000 women/year– Patch: Patch: 5.3/10,000 women/year5.3/10,000 women/year– Age-adj RR: Age-adj RR: 1.1 (95% CI: 0.7-1.8)1.1 (95% CI: 0.7-1.8)

DVT risk declines with increasing duration of useDVT risk declines with increasing duration of use Progestin type, dose have no (or minimal) impact Progestin type, dose have no (or minimal) impact No attributable risk of fatal PTE in OC usersNo attributable risk of fatal PTE in OC users HTN, hypercholesterolemia, and diabetes not risk HTN, hypercholesterolemia, and diabetes not risk

factors for venous diseasefactors for venous disease

Comparative Risks of VTEComparative Risks of VTEIn

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Shulman, LP. J Reprod Med. 2003. Chang, J. In: Surveillance Summaries. 2003.

551515

20-3020-30

6060

Prior Venous Thrombosis and Prior Venous Thrombosis and CHCCHC

Conventional wisdomConventional wisdom If a woman has h/o idiopathic or post-If a woman has h/o idiopathic or post-

partum DVT or VTE, may be predisposed partum DVT or VTE, may be predisposed to recurrence if given exogenous estrogento recurrence if given exogenous estrogen– HenceHence, avoid E- containing contraceptives, avoid E- containing contraceptives

If DVT related to another condition (e.g., If DVT related to another condition (e.g., immobilization, trauma), without a history immobilization, trauma), without a history of recurrence, E-containing contraceptives of recurrence, E-containing contraceptives may be consideredmay be considered

Venous Thrombosis and CHCVenous Thrombosis and CHCFactor V Leiden mutation (FVLM)Factor V Leiden mutation (FVLM), DVT risk, and OCs, DVT risk, and OCs Individuals with the FVLM have activated Protein C Individuals with the FVLM have activated Protein C

resistance and hypercoagulabilityresistance and hypercoagulability

Present in 70-90% of inherited thrombophiliasPresent in 70-90% of inherited thrombophilias– 20-40% of patients having a first DVT20-40% of patients having a first DVT– 50% of those with > 1 episode of DVT50% of those with > 1 episode of DVT

1-5% US pop; 5% Europeans; 15% of Scandinavians1-5% US pop; 5% Europeans; 15% of Scandinavians

OC users with FVLM have 15 fold increased risk of DVTOC users with FVLM have 15 fold increased risk of DVT Eur J Contracept Reprod Health Care. 2000 Jun;5(2):105-12. Factor V Leiden mutation and the risks for thromboembolic disease: a clinical perspective Ann Intern Med. 1997 Nov 15;127(10):895-903.

Venous Thrombosis Venous Thrombosis and CHCand CHC

Superficial varicose veins Superficial varicose veins do notdo not increase increase the risk of DVT or VTE, regardless methodthe risk of DVT or VTE, regardless method

Women who are about to undergo Women who are about to undergo major major surgery should discontinue OC’s 30 days surgery should discontinue OC’s 30 days before the procedure is scheduledbefore the procedure is scheduled

Not necessary to interrupt OC’s before Not necessary to interrupt OC’s before short operative procedures with early short operative procedures with early physical activityphysical activity

a) History of DVT/PE, a) History of DVT/PE, not on anticoagulant not on anticoagulant therapytherapy

OC/P/ROC/P/R POPPOP DMPADMPA ImpImpll

LNGLNG-IUD-IUD

Cu-Cu-IUDIUD

i.) Higher risk for i.) Higher risk for recurrent DVT/PE recurrent DVT/PE

44 22 22 22 22 11

ii.) Lower risk for ii.) Lower risk for recurrent DVT/PE recurrent DVT/PE (no risk factors)(no risk factors)

33 22 22 22 22 11

USMEC: USMEC: Deep Venous ThrombosisDeep Venous Thrombosis

USMEC: History of DVT/PEUSMEC: History of DVT/PENNot on Anticoagulant ot on Anticoagulant Therapy Therapy Higher risk for recurrent DVT/PE Higher risk for recurrent DVT/PE

– History of estrogen-associated DVT/PE History of estrogen-associated DVT/PE – Pregnancy-associated DVT/PE Pregnancy-associated DVT/PE – Idiopathic DVT/PE Idiopathic DVT/PE – Thrombophilia; antiphospholipid syndrome Thrombophilia; antiphospholipid syndrome – Active cancer (metastatic, on therapy, or < Active cancer (metastatic, on therapy, or <

6 months after clinical remission)6 months after clinical remission)– History of recurrent DVT/PEHistory of recurrent DVT/PE

OC/OC/P/RP/R

POPPOP DMPDMPAA

ImImplpl

LNGLNG-IUD-IUD

Cu-Cu-IUDIUD

b) Acute DVT/PEb) Acute DVT/PE 44 22 22 22 22 22c) DVT/PE, c) DVT/PE, established on established on anticoagulants anticoagulants >>3 3 momoi) Higher risk for i) Higher risk for recurrent DVT/PE recurrent DVT/PE

44 22 22 22 22 22

ii) Lower risk for ii) Lower risk for recurrent DVT/PE recurrent DVT/PE

33 22 22 22 22 22

USMEC: Deep Venous ThrombosisUSMEC: Deep Venous Thrombosis

OC/P/ROC/P/R POPPOP DMPADMPA ImplImpl LNG-LNG-IUDIUD

Cu-Cu-IUDIUD

d) Family history d) Family history (first-deg relatives)(first-deg relatives)

22 11 11 11 11 11

e) Major surgerye) Major surgery

(i) with prolonged (i) with prolonged immobilizationimmobilization

44 22 22 22 22 11

(ii) without (ii) without prolonged prolonged immobilizationimmobilization

22 11 11 11 11 11

f) Minor surgery f) Minor surgery without without immobilizationimmobilization

11 11 11 11 11 11

USMEC: Deep Venous Thrombosis

Case Study: Prior DVT Case Study: Prior DVT Recommend coagulation studies, since may Recommend coagulation studies, since may

affect contraceptive choice and pregnancy affect contraceptive choice and pregnancy managementmanagement

Preferred methodsPreferred methods– Cu-IUDCu-IUD

Acceptable methodsAcceptable methods– POP, DMPA, IMPLT, LNG-IUDPOP, DMPA, IMPLT, LNG-IUD

Unacceptable riskUnacceptable risk– COC, patch, ringCOC, patch, ring

Case StudyCase Study

A 25 y.o. female with Crohn’s disease desires A 25 y.o. female with Crohn’s disease desires long-term reversible contraception and is long-term reversible contraception and is thinking about the levonorgestrel-releasing thinking about the levonorgestrel-releasing IUD. Is this method safe for her?IUD. Is this method safe for her?

A. Yes

B. No

Inflammatory Bowel Inflammatory Bowel Disease (IBD)Disease (IBD) New condition added to US MECNew condition added to US MEC Two chronic relapsing and remitting Two chronic relapsing and remitting

disorders of GI tractdisorders of GI tract– Ulcerative colitisUlcerative colitis– Crohn's diseaseCrohn's disease

Common symptoms: diarrhea, abd Common symptoms: diarrhea, abd cramps, rectal bleeding, frequent bowel cramps, rectal bleeding, frequent bowel mov't, weight loss, anemiamov't, weight loss, anemia

Inflammatory Bowel Inflammatory Bowel DiseaseDisease

More common among womenMore common among women– UC: UC: 160/100:000 women160/100:000 women– Crohn's: Crohn's: 103/100,000 women103/100,000 women

RisksRisks– ThrombosisThrombosis

Some studies show increased risk, others notSome studies show increased risk, others not Risk greater during active-disease phaseRisk greater during active-disease phase

– MalabsorptionMalabsorption Osteoporosis and osteopeniaOsteoporosis and osteopenia

All may be of concern for contraceptive useAll may be of concern for contraceptive use

IBD- EvidenceIBD- Evidence

10 studies10 studies Relapse rates- no difference in time to Relapse rates- no difference in time to

relapse in women using POPS or COCsrelapse in women using POPS or COCs Exacerbation- case reports of LNG-IUD use Exacerbation- case reports of LNG-IUD use

causing exacerbationcausing exacerbation Absorption- pharmacokinetic studies Absorption- pharmacokinetic studies

showed no difference among UC patients showed no difference among UC patients compared with healthy women in compared with healthy women in absorption of EE or LNGabsorption of EE or LNG

IBD- GapsIBD- Gaps Small number of studies, small sample sizes, Small number of studies, small sample sizes,

methodologic concernsmethodologic concerns

No studies examining risk of thrombosis in women No studies examining risk of thrombosis in women with IBD using hormonal contraceptiveswith IBD using hormonal contraceptives

No studies on IBD, DMPA, bone loss / fracture riskNo studies on IBD, DMPA, bone loss / fracture risk

Pharmokinetic studies only among women with UC Pharmokinetic studies only among women with UC (affects large bowel)(affects large bowel)

Inflammatory Bowel Inflammatory Bowel DiseaseDisease

CONDITIONCONDITION COC/COC/P/RP/R

POPPOP DMPADMPA Imp-Imp-lantslants

LNGLNG-IUD-IUD

Cu-Cu-IUDIUD

IBD IBD (Ulcerative (Ulcerative colitis, colitis, Crohn’s Crohn’s disease)disease)

2/32/3 22 22 11 11 11

Inflammatory Bowel Inflammatory Bowel DiseaseDisease

For women with mild IBD, with no other For women with mild IBD, with no other risk factor for \/TE, the benefits of COC/P/R risk factor for \/TE, the benefits of COC/P/R use generally outweigh the risks use generally outweigh the risks (Category 2)(Category 2)

For women with IBD with increased risk of For women with IBD with increased risk of \/TE (e.g., those with active or extensive \/TE (e.g., those with active or extensive disease, surgery, immobilization, steroid disease, surgery, immobilization, steroid use, vitamin deficiency, fluid depletion), use, vitamin deficiency, fluid depletion), risks > benefit (Category 3)risks > benefit (Category 3)

OC/P/ROC/P/R POPPOP DMDMPAPA

ImImplaplantnt

CuCuIUCIUC

LN-LN-IUCIUC

Restrictive Restrictive procedures: procedures: decrease stomach decrease stomach storage capacitystorage capacity

11 11 11 11 11 11

Malabsorptive Malabsorptive procedures: shorten procedures: shorten functional length of functional length of the SBthe SB

COCs: 3 COCs: 3 P/R: 1P/R: 1

33 11 11 11 11

USMEC: History of USMEC: History of Bariatric SurgeryBariatric Surgery

OC/P/ROC/P/R POPPOP DMPDMPAA

ImpImplanlantt

Cu-Cu-IUCIUC

LN-LN-IUCIUC

Complicated: graft Complicated: graft failure, rejection, failure, rejection, cardiac allograft, cardiac allograft, vasculopathyvasculopathy

44 22 22 22 I = I = 33C C =2=2

I = I = 33C C =2=2

UncomplicatedUncomplicated 22 22 22 22 22 22

USMEC: Solid Organ USMEC: Solid Organ TransplantationTransplantation

Women with Budd-Chiari syndrome should not use COC/P/R because of the increased risk for thrombosis

SummarySummary

The CDC Medical Eligibility Criteria is an evidence The CDC Medical Eligibility Criteria is an evidence based tool to determine safe contraceptive options based tool to determine safe contraceptive options for women with medical problemsfor women with medical problems

Most woman overestimate the risks of Most woman overestimate the risks of contraception and don’t understand the medical contraception and don’t understand the medical benefits and safety of hormonal contraception benefits and safety of hormonal contraception

Remember to think about contraception when Remember to think about contraception when prescribing FDA Category D or X medications prescribing FDA Category D or X medications (potentially dangerous in pregnancy) (potentially dangerous in pregnancy)