an evidence-based approach to contraception in women with medical disease jody steinauer, md, mas...

An Evidence-based An Evidence-based Approach to Approach to

Contraception in Women Contraception in Women with Medical Diseasewith Medical Disease

Jody Steinauer, MD, MASJody Steinauer, MD, MAS

University of CA, San FranciscoUniversity of CA, San Francisco

ObjectivesObjectives

At the end of this talk you will be able At the end of this talk you will be able to:to: Easily access evidence-based

recommendations for contraception in women with medical illness

Understand the underlying evidence for these recommendations

Balance the risks of contraception against the risks of pregnancy in these women

OutlineOutline Review WHO guidelines for Review WHO guidelines for

contraceptioncontraception Review evidence for specific medical Review evidence for specific medical

situations and specific methodssituations and specific methods Migraines Diabetes, HTN, CAD risk factors Postpartum Drug interactions

Review contraindications by methodReview contraindications by method Combined hormonal, progestin, IUC

Janet is a 24 yo woman with migraines Janet is a 24 yo woman with migraines who comes to you for an annual who comes to you for an annual examination. She desires the patch examination. She desires the patch for birth control. Can she use it?for birth control. Can she use it?

Reviewing Evidence for Reviewing Evidence for ContraceptionContraception

Medical Eligibility Criteria for Medical Eligibility Criteria for Contraceptive UseContraceptive Use www.who.int, full text on line or $23!!

Managing Contraception 2004-2005Managing Contraception 2004-2005 Includes the WHO guidelines! Also includes the CDC STI guidelines and

other important information.

WHO Eligibility Criteria for WHO Eligibility Criteria for Use of a Contraceptive MethodUse of a Contraceptive Method 11 No restrictionNo restriction

Use the method 2 Advantages of method outweigh 2 Advantages of method outweigh

the risksthe risks Generally use the method

3 Risks outweigh the advantages3 Risks outweigh the advantages Use only if no other method available

4 Unacceptable health risk if method 4 Unacceptable health risk if method usedused Do not use the method

Medical Eligibility Criteria for Contraceptive Use Medical Eligibility Criteria for Contraceptive Use (www.who.int/reproductive-health)(www.who.int/reproductive-health)

Migraine EpidemiologyMigraine Epidemiology

18% of U.S. women had one or more 18% of U.S. women had one or more migraines per yearmigraines per year11

Three times more common in women Three times more common in women Dutch women (population-based studyDutch women (population-based study22))

33% ever had migraines 25% in the last year 18% of 20-24 year olds ever had migraines

64% Migraine; 18% with Aura; 13% 64% Migraine; 18% with Aura; 13% bothboth

1. Stewart et al. Prevalence of migraine headaches in the US. JAMA 1992;267:64-692. Launer et al. The prevalence and characteristics of migraine in a population-based cohort,The GEM study. Neurology 1999;53:537-42

StrokeStroke The absolute risk of stroke in young The absolute risk of stroke in young

women is low at <1 per 10,000 women-women is low at <1 per 10,000 women-years.years.

Risk factors:Risk factors: Smoking Age > 35, Obesity, FH of stroke <45 HTN, CVD, diabetes, hyperlipidemia Migraine with and without aura

The International Headache Society Task Force on Combined Oral Contraceptives and HRT. Recommendations on the risk of ischemic stroke associated with use of combined oral contraceptivesand HRT in women with migraine. Cephalalgia 2000;20:155-56

Migraine, OCPs, and StrokeMigraine, OCPs, and Stroke

Migraine and stroke:Migraine and stroke: Migraine1 (general): RR 2.2 – RR 3.52

Migraine without aura: RR 1.61 – RR 3.02

Migraine with aura: RR 2.91 – RR 6.22

COC and stroke:COC and stroke: RR 2.13 -3.52

1. Etminan et al. BMJ, 2005; 330(7482): 63. 2. Tzourio et al. BMJ, 1995; 310: 830-33. 3. Gillum et al. JAMA, 2000, 284:72-8.

Migraine, OCPs, and Migraine, OCPs, and StrokeStroke

Synergistic effect Synergistic effect

Migraine and COC:

OR 1.9 (95% CI 1.3-2.7) 1

OR 8.7 (95% CI 5.0-15.0) 2

OR 13.9 (95% CI 5.5-35.1) 3

1. Gillum et al. JAMA, 2000, 284:72-8. 2. Etminan et al. BMJ, January 8, 2005; 330(7482): 63.3. Tzourio C et al. BMJ, 1995, 310:830-3.

Attributable Risk from CHCAttributable Risk from CHC Absolute risks of stroke in young women:Absolute risks of stroke in young women:

6 per 100,000 ♀ / year – healthy 12 per 100,000 ♀ / year – migraine 18 per 100,000 ♀ / year – migraine with aura 12 per 100,000 ♀ / year – healthy and COC 19 per 100,000 ♀ / year – migraine and COC 30 per 100,000 ♀ / year – migraine with aura and

COC 34 per 100,000 ♀ / year – stroke in pregnancy

Attributable risk: 7-12 per 100,000 women Attributable risk: 7-12 per 100,000 women per yearper year

(Much higher in women who smoke too: OR (Much higher in women who smoke too: OR 34!)34!)

WHO: Headaches and CHC WHO: Headaches and CHC

Initiate ContinueInitiate ContinueNon migranousNon migranous (mild or severe) (mild or severe) 11

22MigraineMigraine

(i) without focal neurologic symptoms(i) without focal neurologic symptomsAge < 35 Age < 35 22 33

Age > 35 Age > 35 33 4 4(ii) with focal neurologic symptoms(ii) with focal neurologic symptoms 44 44 (at any age)(at any age)

Prodrome = photo/phonophobia, N/V Prodrome = photo/phonophobia, N/V

Focal symptoms = vision changes, numbness, parasthesiasFocal symptoms = vision changes, numbness, parasthesiashttp://www.who.int/reproductive-health/publications/RHR_00_2_medical_eligibility_criteria_3rd/

““AURA”AURA” Focal neurological symptoms that occur just

before or at the onset of the headache Not the same as premonitory or resolution

symptoms: (hypo- or hyperactivity, depression, food cravings,

yawning, fatigue, difficulty concentrating) Reversible symptoms that develop gradually

over 5-20 minutes and last up to 60 minutes Most common - visual

Hormonal Contraception Hormonal Contraception for Women with Migrainesfor Women with Migraines

Considerations for CHCsConsiderations for CHCs Lower & consistent estrogen levels with ring Consider 20 or 25 mcg pills Consider eliminating the placebo week in

women who have migraines triggered by withdrawal of estrogen

Regular follow-up in 1-3 months after initial Rx

Stress need to discontinue method if HAs worsen

Any Progestin-Only MethodAny Progestin-Only Method

Janet is a 24 yo woman with migraines Janet is a 24 yo woman with migraines who comes to you for an annual who comes to you for an annual examination. She desires the patch examination. She desires the patch for birth control. Can she use it?for birth control. Can she use it?

Contraception and Medical Contraception and Medical ConditionsConditions

DiabetesDiabetes HypertensionHypertension Cardiovascular Risk FactorsCardiovascular Risk Factors PostpartumPostpartum Other casesOther cases

DiabetesDiabetes CHCCHC DMPADMPA

NIDDMNIDDM 22 2 2IDDMIDDM

No vascular diseaseNo vascular disease 22 2 2 Vascular diseaseVascular disease 3/43/4 3 3

Duration > 20 yearsDuration > 20 years 3/43/4 3 3

Copper IUD - 1Levonorgestrel IUS - 2

DiabetesDiabetes Even if uncomplicated diabetes, when Even if uncomplicated diabetes, when

combined with other risk factor for CVD, combined with other risk factor for CVD, no CHCno CHC

CHC:CHC: Progestin competitive inhibitor of

insulin – choose with low progesterone activity

Estrogen – decreases insulin release – low estrogen dose

HypertensionHypertension

CHCCHC

ProgesProgestin tin

ImplanImplantt

DMPDMPAA

Cu-Cu-IUDIUD

LNG-LNG-IUSIUS

BP systolic 140-159 BP systolic 140-159 or diastolic 90-99or diastolic 90-99 33 11 22 11 11

BP systolic >=160 BP systolic >=160 or diastolic >=100or diastolic >=100 44 22 33 11 22

Controlled Controlled hypertensionhypertension 33 11 22 11 11

History of History of Gestational HTNGestational HTN 22 11 11 11 11

Cardiovascular Risk FactorsCardiovascular Risk Factors

CHCCHC

ProgesProgestin tin

ImplanImplantt

DMPDMPAA

Cu-Cu-IUDIUD

LNG-LNG-IUSIUS

Multiple risk Multiple risk factors of CADfactors of CAD 3/43/4 22 33 11 22

BP systolic >160 BP systolic >160 or diastolic >100or diastolic >100 44 22 33 11 22

Vascular diseaseVascular disease 44 22 33 11 22

History of DVT/PEHistory of DVT/PE 44 22 22 11 22

Current DVT/PECurrent DVT/PE 44 33 33 11 33

Major surgery- Major surgery- prolonged prolonged immobilizationimmobilization

44 22 22 11 22

Cardiovascular Risk Factors Cardiovascular Risk Factors (cont.)(cont.)

CHCCHC

ProgesProgestin tin

ImplanImplantt

DMPDMPAA

Cu-Cu-IUDIUD

LNG-LNG-IUSIUS

Current/ h/o Current/ h/o ischemic heart ischemic heart diseasedisease

44 33 2/2/33 11 2/2/33

StrokeStroke 44 33 2/2/33 11 22

Any age smokerAny age smoker 22 11 11 11 11

Age >35 and Age >35 and smokes smokes

<15 cigs/day<15 cigs/day33 11 11 11 11

Age >35 and Age >35 and smokes smokes

>15 cigs/day>15 cigs/day44 11 11 11 11

Postpartum and Postpartum and BreastfeedingBreastfeeding

CHCCHC

ProgesProgestin tin

ImplanImplantt

DMPDMPAA

Cu-Cu-IUDIUD

LNG-LNG-IUSIUS

Breastfeeding Breastfeeding

< 6 weeks PP< 6 weeks PP44 33 33 ** **

6 weeks to 6 6 weeks to 6 months months PPPP

33 11 11 11 11

Postpartum Postpartum

< 21 days< 21 days33 11 11 33 33

3-4 wks3-4 wks 11 11 11 33 33

> 4 wks> 4 wks 11 11 11 11 11* See below.

Drug Interactions withDrug Interactions withCHCs, POPs and LNG-IUSCHCs, POPs and LNG-IUS

Induction of liver enzymes, increased Induction of liver enzymes, increased metabolism of steroids: lower effectivenessmetabolism of steroids: lower effectiveness

Other method or increased dose with Other method or increased dose with shortened hormone-free intervalshortened hormone-free interval CHC, Progestin pill, Progestin Implant

3: Rifampicin (Even if only given for 2 days, assume increased metabolism for 4 weeks, back-up method)

3: Anticonvulsants: Phenytoin, barbiturates, carbamazepine, primadone, topiramate, oxcarbazepine

2: Griseofulvin 1: All Other Antibiotics

Other Medical ConditionsOther Medical Conditions

CasesCases

Contraindications by Contraindications by MethodMethod

Combined Hormonal ContraceptionCombined Hormonal Contraception Progestin Injection Progestin Injection Intrauterine ContraceptionIntrauterine Contraception

Combined Hormonal Combined Hormonal ContraceptionContraception

Cardiovascular Disease 3 / 4 Multiple risk factors 3: HTN currently controlled, or systolic 140-159,

diastolic 90-99 4: Systolic > 160, diastolic >100 4: Vascular Disease 4: DVT (History of, or Current) 4: Major surgery with prolonged immobilization

4: Stroke, Ischaemic Heart Disease (History of or Current)

4: Complicated Valvular disease

Combined Hormonal Combined Hormonal ContraceptionContraception

Breast CancerBreast Cancer 4: Current breast cancer 3: H/O breast cancer and NED for 5 years

Gastrointestinal ConditionsGastrointestinal Conditions 4: Active hepatitis or severe cirrhosis 4: Benign or malignant liver tumors 3: Symptomatic gallbladder disease

Neurologic ConditionsNeurologic Conditions 3: Migraine without Aura, >35 4: Migraine with Aura

Progestin Injection Progestin Injection Cardiovascular DiseaseCardiovascular Disease

3: Current DVT or PE 3: Systolic BP 160 or DBP 100 3: Vascular disease 3: Current/ h/o ischemic heart disease 3: Stroke

Breast DiseaseBreast Disease 4: Current breast cancer 3: H/o breast cancer and NED

Progestin Injection Progestin Injection (cont.)(cont.)

MigrainesMigraines 3: Continuation if develops migraines with

aura on injection Gastrointestinal ConditionsGastrointestinal Conditions

3: Active hepatitis or severe cirrhosis 3: Benign or malignant liver tumors

Intrauterine ContraceptionIntrauterine Contraception

Discrepancies between product Discrepancies between product labeling and WHO guidelineslabeling and WHO guidelines

Recent change in Copper T IUD Recent change in Copper T IUD labeling c/w WHO guidelineslabeling c/w WHO guidelines

LNG-IUS “Recommended LNG-IUS “Recommended patient profile” From Package patient profile” From Package

InsertInsert In a stable, mutually monogamous relationshipIn a stable, mutually monogamous relationship No history of pelvic inflammatory disease No history of pelvic inflammatory disease

unless subsequent intrauterine pregnancy - unless subsequent intrauterine pregnancy - WHO 2WHO 2

No history of ectopic pregnancy or No history of ectopic pregnancy or condition that would predispose to condition that would predispose to ectopic pregnancy – WHO 1ectopic pregnancy – WHO 1

Have had at least one child – WHO 2Have had at least one child – WHO 2 No IV drug abuse, AIDS, leukemia – WHO 2No IV drug abuse, AIDS, leukemia – WHO 2 No unresolved, abnormal pap smear – WHO 2No unresolved, abnormal pap smear – WHO 2 No liver disease – WHO 3 for severeNo liver disease – WHO 3 for severe

LNG-IUS and Risk of LNG-IUS and Risk of Ectopic PregnancyEctopic Pregnancy

Mirena prevents intrauterine pregnancy Mirena prevents intrauterine pregnancy more effectively than ectopic pregnancymore effectively than ectopic pregnancy

Pregnancy rate overall = 1-2/1000Pregnancy rate overall = 1-2/1000 Even if ALL pregnancies were ectopic, Even if ALL pregnancies were ectopic,

rate would still be lower than population rate would still be lower than population raterate

WHO category 1WHO category 1

Copper T “Contraindications” Copper T “Contraindications” New LabelNew Label

Pregnancy or suspicion of Pregnancy or suspicion of pregnancypregnancy

Distorted uterine cavityDistorted uterine cavity Acute PID or Acute PID or history of PIDhistory of PID Post-partum endometritis or Post-partum endometritis or

infected abortioninfected abortion in past 3 months in past 3 months Uterine or cervical cancer Uterine or cervical cancer or or

unresolved abnormal Pap smearunresolved abnormal Pap smear Genital bleeding of unknown Genital bleeding of unknown

sourcesource Untreated acuteUntreated acute cervicitis cervicitis or or

vaginitisvaginitis Wilson’s diseaseWilson’s disease Allergy to copperAllergy to copper Patient or partner with multiple Patient or partner with multiple

partnerspartners Increased susceptibility to Increased susceptibility to

infection (AIDS, leukemia, etc)infection (AIDS, leukemia, etc) Genital actinomycosisGenital actinomycosis Current IUD in placeCurrent IUD in place

Pregnancy or suspicion of Pregnancy or suspicion of pregnancypregnancy

Distorted uterine cavityDistorted uterine cavity Acute PID or current Acute PID or current

behavior behavior suggesting a high suggesting a high risk for PIDrisk for PID

Postpartum or postabortal Postpartum or postabortal endometritis in the past 3 endometritis in the past 3 monthsmonths

Known or suspected Known or suspected uterine or cervical uterine or cervical malignancymalignancy

Genital bleeding of Genital bleeding of unknown sourceunknown source

Mucopurulent cervicitisMucopurulent cervicitis Wilson’s diseaseWilson’s disease Allergy to copperAllergy to copper Previously placed Previously placed

intrauterine contraceptive intrauterine contraceptive that has not been removedthat has not been removed

Previous labelPrevious label New FDA-approved labelNew FDA-approved label

Other IUC CasesOther IUC Cases IUC for women with HIVIUC for women with HIV

Often desire effective contraception WHO category 2 for HIV or AIDS but clinically

well on therapy Women with an abnormal papWomen with an abnormal pap

88% of women with an “abnormal” pap don’t need a LEEP or intervention

IUC strings can be tucked up for LEEP, then retrieved

WHO category 2

LNG-IUSLNG-IUS Personal Characteristics and Personal Characteristics and

Reproductive HistoryReproductive History 4: Pregnancy 4: Immediate post-septic abortion 4: Distorted uterine cavity

Neurologic ConditionsNeurologic Conditions 2/3: Migraine with focal neurologic symptoms

Cardiovascular DiseaseCardiovascular Disease 3: Current DVT or PE 2/3: Current/ h/o ischemic heart disease

Gastrointestinal ConditionsGastrointestinal Conditions 3: Viral hepatitis 3: Severe Cirrhosis 3: Liver tumors

LNG-IUSLNG-IUS HIV/AIDSHIV/AIDS

2: HIV-positive 3: AIDS – not clinically well

Reproductive Tract Infections and Reproductive Tract Infections and DisordersDisorders 3 or 4: Cancer (cervical, endometrial, ovarian) 4: Uterine fibroids with distortion of the uterine

cavity 4/2: PID – current or within the last three months 4/2: STIs – current or within the last three months 3: Increased risk of STIs (e.g. multiple partners) 2: Past h/o PID with no pregnancy

Copper IUDCopper IUD Personal Characteristics and Personal Characteristics and

Reproductive HistoryReproductive History 4: Pregnancy 4: Immediate post-septic abortion 4: Distorted uterine cavity

Reproductive Tract Infections and Reproductive Tract Infections and DisordersDisorders 3 or 4: Cancer (cervical, endometrial, ovarian) 4/2: PID – current or within the last three months 4/2: STIs – current or within the last three months 3: Increase risk of STIs (e.g. multiple partners) 2: Past h/o PID with no pregnancy

Copper IUD Copper IUD (cont.)(cont.)

HIV/AIDSHIV/AIDS 3: AIDS – not clinically well

Gastrointestinal ConditionsGastrointestinal Conditions 3: Severe cirrhosis

ConclusionConclusion

WHO publishes excellent, evidence-WHO publishes excellent, evidence-based resource of recommendations based resource of recommendations for contraception in medically for contraception in medically complicated women.complicated women.

Risks must be balanced with risks of Risks must be balanced with risks of pregnancy.pregnancy.

AcknowledgementsAcknowledgements

Tina RaineTina Raine Felisa PreskillFelisa Preskill Phil Darney, and fellows in family Phil Darney, and fellows in family

planning at UCSFplanning at UCSF

ResourcesResources

UCSF Family Planning Consultation ServiceUCSF Family Planning Consultation Service 415 719-6318

Medical Eligibility Criteria for Contraceptive UseMedical Eligibility Criteria for Contraceptive Use www.who.int, full text on line or $23!!

BooksBooks Darney P and Speroff L. A Clinical Guide for

Contraception 2001. Hatcher RA, et al. Contraceptive Technology 2004. Hatcher RA, et al. A Pocket Guide to Managing

Contraception 2004-2005. Guillebaud J. Contraception-Your Questions Answered

2004.

ResourcesResources

UCSF Family Planning Consultation ServiceUCSF Family Planning Consultation Service 415 719-6318

Medical Eligibility Criteria for Contraceptive UseMedical Eligibility Criteria for Contraceptive Use www.who.int, full text on line or $23!!

BooksBooks Darney P and Speroff L. A Clinical Guide for

Contraception 2001. Hatcher RA, et al. Contraceptive Technology 2004. Hatcher RA, et al. A Pocket Guide to Managing

Contraception 2004-2005. Guillebaud J. Contraception-Your Questions Answered

2004.

On-line ResourcesOn-line Resources

Medical Eligibility Criteria for Medical Eligibility Criteria for Contraceptive Use by WHO (Contraceptive Use by WHO (www.who.intwww.who.int), ), $23!!$23!!

ARHP (ARHP (www.arhp.orgwww.arhp.org)) Managing contraception (Managing contraception (

www.managingcontraception.orgwww.managingcontraception.org)) Alan Guttmacher Institute (Alan Guttmacher Institute (

www.agi-usa.orgwww.agi-usa.org)) www.contraceptiononline.orgwww.contraceptiononline.org http://http://www.NOT-2-LATEwww.NOT-2-LATE.com.com