1. An Evidence-based Approach to Contraception in Women with Medical Disease Jody Steinauer, MD, MAS University of CA, San Francisco

2. Objectives At the end of this talk you will be able to: At the end of this talk you will be able 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

3. Outline Review WHO guidelines for contraception Review WHO guidelines for contraception Review evidence for specific medical situations and specific methods Review evidence for specific medical situations and specific methods Migraines Diabetes, HTN, CAD risk factors Postpartum Drug interactions Review contraindications by method Review contraindications by method Combined hormonal, progestin, IUC

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

5. Reviewing Evidence for Contraception Medical Eligibility Criteria for Contraceptive Use Medical Eligibility Criteria for Contraceptive Use www.who.int, full text on line or $23!! Managing Contraception 2004-2005 Managing Contraception 2004-2005 Includes the WHO guidelines! Also includes the CDC STI guidelines and other important information.

6. WHO Eligibility Criteria for Use of a Contraceptive Method 1 No restriction 1 No restriction Use the method 2 Advantages of method outweigh the risks 2 Advantages of method outweigh the risks Generally use the method 3 Risks outweigh the advantages 3 Risks outweigh the advantages Use only if no other method available 4 Unacceptable health risk if method used 4 Unacceptable health risk if method used Do not use the method Medical Eligibility Criteria for Contraceptive Use (www.who.int/reproductive-health)

7. Migraine Epidemiology 18% of U.S. women had one or more migraines per year 1 18% of U.S. women had one or more migraines per year 1 Three times more common in women Three times more common in women Dutch women (population-based study 2 ) Dutch women (population-based study 2 ) 33% ever had migraines 25% in the last year 18% of 20-24 year olds ever had migraines 64% Migraine; 18% with Aura; 13% both 64% Migraine; 18% with Aura; 13% both 1. Stewart et al. Prevalence of migraine headaches in the US. JAMA 1992;267:64-69 2. Launer et al. The prevalence and characteristics of migraine in a population-based cohort, The GEM study. Neurology 1999;53:537-42

8. Stroke The absolute risk of stroke in young women is low at <1 per 10,000 women-years. The absolute risk of stroke in young women is low at <1 per 10,000 women-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 contraceptives and HRT in women with migraine. Cephalalgia 2000;20:155-56

9. Migraine, OCPs, and Stroke Migraine and stroke: Migraine 1 (general): RR 2.2 – RR 3.5 2 Migraine without aura: RR 1.6 1 – RR 3.0 2 Migraine with aura: RR 2.9 1 – RR 6.2 2 COC and stroke: RR 2.1 3 -3.5 2 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.

10. Migraine, OCPs, and Stroke 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.

11. Attributable 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 per year Attributable risk: 7-12 per 100,000 women per year (Much higher in women who smoke too: OR 34!) (Much higher in women who smoke too: OR 34!)

12. WHO: Headaches and CHC Initiate Continue Initiate Continue Non migranous (mild or severe)1 2 Migraine (i) without focal neurologic symptoms Age < 35 2 3 Age > 35 3 4 Age > 35 3 4 (ii) with focal neurologic symptoms4 4 (at any age) (at any age) Prodrome = photo/phonophobia, N/V Focal symptoms = vision changes, numbness, parasthesias http://www.who.int/reproductive-health/publications/RHR_00_2_medical_eligibility_criteria_3rd/

13. 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

14. Hormonal Contraception for Women with Migraines Considerations for CHCs Considerations 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 Method Any Progestin-Only Method

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

16. Contraception and Medical Conditions Diabetes Diabetes Hypertension Hypertension Cardiovascular Risk Factors Cardiovascular Risk Factors Postpartum Postpartum Other cases Other cases

17. Diabetes CHCDMPA CHCDMPA NIDDM 2 2 IDDM No vascular disease2 2 Vascular disease3/4 3 Vascular disease3/4 3 Duration > 20 years3/4 3 Copper IUD - 1 Levonorgestrel IUS - 2

18. Diabetes Even if uncomplicated diabetes, when combined with other risk factor for CVD, no CHC Even if uncomplicated diabetes, when combined with other risk factor for CVD, no CHC CHC: CHC: Progestin competitive inhibitor of insulin – choose with low progesterone activity Estrogen – decreases insulin release – low estrogen dose

19. Hypertension CHC Progestin Implant DMPA Cu- IUD LNG- IUS BP systolic 140-159 or diastolic 90-99 31211 BP systolic >=160 or diastolic >=100 42312 Controlled hypertension 31211 History of Gestational HTN 21111

20. Cardiovascular Risk Factors CHC Progestin Implant DMPA Cu- IUD LNG- IUS Multiple risk factors of CAD 3/42312 BP systolic >160 or diastolic >100 42312 Vascular disease 42312 History of DVT/PE 42212 Current DVT/PE 43313 Major surgery- prolonged immobilization 42212

21. Cardiovascular Risk Factors (cont.) CHC Progestin Implant DMPA Cu- IUD LNG- IUS Current/ h/o ischemic heart disease 43 2/3 1 Stroke43 12 Any age smoker 21111 Age >35 and smokes <15 cigs/day 31111 Age >35 and smokes >15 cigs/day 41111

22. Postpartum and Breastfeeding CHC Progestin Implant DMPA Cu- IUD LNG- IUS Breastfeeding < 6 weeks PP < 6 weeks PP433** 6 weeks to 6 months PP 6 weeks to 6 months PP31111 Postpartum < 21 days < 21 days3113 3 3-4 wks 11133 > 4 wks > 4 wks11111 * See below.

23. Drug Interactions with CHCs, POPs and LNG-IUS Induction of liver enzymes, increased metabolism of steroids: lower effectiveness Induction of liver enzymes, increased metabolism of steroids: lower effectiveness Other method or increased dose with shortened hormone- free interval Other method or increased dose with shortened 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

24. Other Medical Conditions Cases Cases

25. Contraindications by Method Combined Hormonal Contraception Combined Hormonal Contraception Progestin Injection Progestin Injection Intrauterine Contraception Intrauterine Contraception

26. Combined Hormonal Contraception 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

27. Combined Hormonal Contraception Breast Cancer Breast Cancer 4: Current breast cancer 3: H/O breast cancer and NED for 5 years Gastrointestinal Conditions Gastrointestinal Conditions 4: Active hepatitis or severe cirrhosis 4: Benign or malignant liver tumors 3: Symptomatic gallbladder disease Neurologic Conditions Neurologic Conditions 3: Migraine without Aura, >35 4: Migraine with Aura

28. Progestin Injection Cardiovascular Disease Cardiovascular 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 Disease Breast Disease 4: Current breast cancer 3: H/o breast cancer and NED

29. Progestin Injection (cont.) Migraines Migraines 3: Continuation if develops migraines with aura on injection Gastrointestinal Conditions Gastrointestinal Conditions 3: Active hepatitis or severe cirrhosis 3: Benign or malignant liver tumors

30. Intrauterine Contraception Discrepancies between product labeling and WHO guidelines Discrepancies between product labeling and WHO guidelines Recent change in Copper T IUD labeling c/w WHO guidelines Recent change in Copper T IUD labeling c/w WHO guidelines

31. LNG-IUS Recommended patient profile From Package Insert In a stable, mutually monogamous relationship In a stable, mutually monogamous relationship No history of pelvic inflammatory disease unless subsequent intrauterine pregnancy - WHO 2 No history of pelvic inflammatory disease unless subsequent intrauterine pregnancy - WHO 2 No history of ectopic pregnancy or condition that would predispose to ectopic pregnancy – WHO 1 No history of ectopic pregnancy or condition that would predispose to ectopic pregnancy – WHO 1 Have had at least one child – WHO 2 Have had at least one child – WHO 2 No IV drug abuse, AIDS, leukemia – WHO 2 No IV drug abuse, AIDS, leukemia – WHO 2 No unresolved, abnormal pap smear – WHO 2 No unresolved, abnormal pap smear – WHO 2 No liver disease – WHO 3 for severe No liver disease – WHO 3 for severe

32. LNG-IUS and Risk of Ectopic Pregnancy Mirena prevents intrauterine pregnancy more effectively than ectopic pregnancy Mirena prevents intrauterine pregnancy more effectively than ectopic pregnancy Pregnancy rate overall = 1-2/1000 Pregnancy rate overall = 1-2/1000 Even if ALL pregnancies were ectopic, rate would still be lower than population rate Even if ALL pregnancies were ectopic, rate would still be lower than population rate WHO category 1 WHO category 1

33. Copper T Contraindications New Label Pregnancy or suspicion of pregnancy Pregnancy or suspicion of pregnancy Distorted uterine cavity Distorted uterine cavity Acute PID or history of PID Acute PID or history of PID Post-partum endometritis or infected abortion in past 3 months Post-partum endometritis or infected abortion in past 3 months Uterine or cervical cancer or unresolved abnormal Pap smear Uterine or cervical cancer or unresolved abnormal Pap smear Genital bleeding of unknown source Genital bleeding of unknown source Untreated acute cervicitis or vaginitis Untreated acute cervicitis or vaginitis Wilson s disease Wilson s disease Allergy to copper Allergy to copper Patient or partner with multiple partners Patient or partner with multiple partners Increased susceptibility to infection (AIDS, leukemia, etc) Increased susceptibility to infection (AIDS, leukemia, etc) Genital actinomycosis Genital actinomycosis Current IUD in place Current IUD in place Pregnancy or suspicion of pregnancy Distorted uterine cavity Acute PID or current behavior suggesting a high risk for PID Postpartum or postabortal endometritis in the past 3 months Known or suspected uterine or cervical malignancy Genital bleeding of unknown source Mucopurulent cervicitis Wilsons disease Allergy to copper Previously placed intrauterine contraceptive that has not been removed Previous label New FDA-approved label

34. Other IUC Cases IUC for women with HIV IUC for women with HIV Often desire effective contraception WHO category 2 for HIV or AIDS but clinically well on therapy Women with an abnormal pap Women with an abnormal pap 88% of women with an abnormal pap dont need a LEEP or intervention IUC strings can be tucked up for LEEP, then retrieved WHO category 2

35. LNG-IUS Personal Characteristics and Reproductive History Personal Characteristics and Reproductive History 4: Pregnancy 4: Immediate post-septic abortion 4: Distorted uterine cavity Neurologic Conditions Neurologic Conditions 2/3: Migraine with focal neurologic symptoms Cardiovascular Disease Cardiovascular Disease 3: Current DVT or PE 2/3: Current/ h/o ischemic heart disease Gastrointestinal Conditions Gastrointestinal Conditions 3: Viral hepatitis 3: Severe Cirrhosis 3: Liver tumors

36. LNG-IUS HIV/AIDS HIV/AIDS 2: HIV-positive 3: AIDS – not clinically well Reproductive Tract Infections and Disorders Reproductive Tract Infections and Disorders 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

37. Copper IUD Personal Characteristics and Reproductive History Personal Characteristics and Reproductive History 4: Pregnancy 4: Immediate post-septic abortion 4: Distorted uterine cavity Reproductive Tract Infections and Disorders Reproductive Tract Infections and Disorders 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

38. Copper IUD (cont.) HIV/AIDS HIV/AIDS 3: AIDS – not clinically well Gastrointestinal Conditions Gastrointestinal Conditions 3: Severe cirrhosis

39. Conclusion WHO publishes excellent, evidence-based resource of recommendations for contraception in medically complicated women. WHO publishes excellent, evidence-based resource of recommendations for contraception in medically complicated women. Risks must be balanced with risks of pregnancy. Risks must be balanced with risks of pregnancy.

40. Acknowledgements Tina Raine Tina Raine Felisa Preskill Felisa Preskill Phil Darney, and fellows in family planning at UCSF Phil Darney, and fellows in family planning at UCSF

41. Resources UCSF Family Planning Consultation Service UCSF Family Planning Consultation Service 415 719-6318 Medical Eligibility Criteria for Contraceptive Use Medical Eligibility Criteria for Contraceptive Use www.who.int, full text on line or $23!! Books Books 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.

42. Resources UCSF Family Planning Consultation Service UCSF Family Planning Consultation Service 415 719-6318 Medical Eligibility Criteria for Contraceptive Use Medical Eligibility Criteria for Contraceptive Use www.who.int, full text on line or $23!! Books Books 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.

43. On-line Resources Medical Eligibility Criteria for Contraceptive Use by WHO (www.who.int), $23!! Medical Eligibility Criteria for Contraceptive Use by WHO (www.who.int), $23!!www.who.int ARHP (www.arhp.org) ARHP (www.arhp.org)www.arhp.org Managing contraception (www.managingcontraception.org) Managing contraception (www.managingcontraception.org)www.managingcontraception.org Alan Guttmacher Institute (www.agi-usa.org) Alan Guttmacher Institute (www.agi-usa.org)www.agi-usa.org www.contraceptiononline.org www.contraceptiononline.org www.contraceptiononline.org http://www.NOT-2-LATE.com http://www.NOT-2-LATE.com http://www.NOT-2-LATE http://www.NOT-2-LATE