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