1. Contraception in medical diseases Dr.Prerna kumari Dr.Vatsla Dadhwal Dr.Murali

2. Contraception Half of pregnancies are unintended Half of unintended pregnancies result from inconsistent or incorrect contraceptive use Risk of method vs. risk of pregnancy What is the most important issue for the clinician prescribing contraception?

3. Objectives – 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

4. WHO Eligibility Criteria for Use of Reversible Contraceptive Method No restriction – Use the method Advantages of method outweigh the risks – Generally use the method Risks outweigh the advantages – Use only if no other method available Unacceptable health risk if method used – Do not use the method Medical Eligibility Criteria for Contraceptive Use 2009 (www.who.int/reproductive- health) 1 2 3 4

5. Sterilization Accept(A)- There is no medical region to deny sterilization to a person with this condition Caution(C)- The procedure is normally conducted in a routine setting, but with extra preparation & precautions Delay(D)- procedure is delayed until the condition is evaluated and/or corrected Special(S)- Procedure should be undertaken in a well equipped setting. Medical Eligibility Criteria for Contraceptive Use (www.who.int/reproductive-health)

6. Which patient,Which method?… Personal characteristics & Reproductive history (Age,Smoking,Obesity,Parity,Postpartum,Postabortion) Cardiovascular disease DVT/PE Neurologic conditions Endocrine conditions Gastrointestinal disease Malignancies Rheumatologic disease Reproductive tract disorders and infections Anemias Drug interactions

7. Personal characteristics & Reproductive history Age- No relation of contraception with age- except in patient ≥40 years-CHC’s- Menarche to 45yrs-DMPA/NET-EN- Menarche to <20yrs(IUD)- 2 2 Bone mineraldensity decreases with long term use of DMPA 2  Risk of expulsion due to nulliparity  Risk of STI’s

8. SMOKING CHC’S <35 and smoke: C2 >35 and smoke <15/day:C3 >35 and smoke > 15/day: C4 ( COC users who smoke are at increased risk for CVD and MI; risk increases with number of cigarettes smoked) POC’S &IUD’S are safe. Medical Eligibility Criteria for Contraceptive Use (www.who.int/reproductive-health)

9. Obesity CHC’S BMI > 30kg/m2 Possible increased risk of VTE, MI, stoke Inconsistent evidence about body wt and efficacy NOT more likely to gain POC’S- C1; C2 <18???NET- EN(Potential effect of NET- EN on bone mineral density) IUD’S- Because of elevated risk for dysfunctional uterine bleeding and endometrial neoplasia, use of levonorgestrel intrauterine system may be a particularly sound choice for obese women 1 2

10. Bariatric Surgery(US-MEC) Restrictive procedures: gastric band or sleeve CHC’S- Malabsorptive procedures COCs: Patch/Rings: 1 3 1

11. Postpartum -Breastfeeding CHC’s- < 6weeks postpartum- ≥6weeks to <6 months postpartum- ≥6 months postpartum-C1 POC’S <6 weeks: IUD’s <48hrs-C3 for LNG-IUD (Concern regarding steroid exposure to neonate) >48 hrs to <4weeks-C3 for LNG-IUD &cu-T both Pueperal sepsis- 4 2 4 3 3 Medical Eligibility Criteria for Contraceptive Use (www.who.int/reproductive-health)

12. Postpartum Nonbreastfeeding CHC’S- < 21 days- >21 days- POC’s - Safe IUD’s ->48 hrs to<4weeks- 3 3 1 Increased risk of thrombosis up to 3 weeks postpartum Increased risk of expulsion Lideggard o et al.Hormonal contraception and risk of venous thromboembolism:national follow up study.British Medical Journal,2009,339

13. Postabortion Immediately post abortion 1 st or 2 nd trimester- hormonal contraception- IUD’S- 2 nd trimester abortion- Immediate Post septic abortion- 1 4 2 Gaffield ME et al.Use of combined oral contraceptivespostabortion.Contraception,2009;80.

14. CVD: Hypertension Adequately controlled/History of hypertension where blood pressure can’t be evaluated: Elevated BP levels: SBP140-159 OR DBP 90-99- SBP > 160 OR DBP > 100- Vascular disease- C4 Hypertension during pregnancy- C2 CHC’S 3 4 3 2 Medical Eligibility Criteria for Contraceptive Use (www.who.int/reproductive-health)

15. Hypertension Contd……. POC’S Adequately controlled/Elevated BP levels SBP 140- 159/DBP 90-99 POP, I: C1, DMPA: C2 Implants:C1 SBP > 160/DBP > 100 POP/I: C2, DMPA: C3 Implants:C2 High BP during pregnancy: C1 IUD’s-cu-C1 LNG-C2 Concern with DMPA: hypoestrogenic states and reduced HDL levels, especially as they persist for a while after discontinuation; not a problem with POPs DVT/PE:no direct evidence exists: POPs and DVT/PE; findings on risk inconsistent Medical Eligibility Criteria for Contraceptive Use (www.who.int/reproductive-health)

16. ACOG recommends -non-smoking women with blood pressure well controlled by antihypertensive agents, under age 35 and otherwise healthy may try combination hormonal contraceptive methods with careful monitoring; if blood pressure remains controlled, use can be continued. Use of combination hormonal methods in women with severe (ie, uncontrolled) hypertension is contraindicated. Progestin-only methods, barrier methods and IUDs are appropriate options for women with either controlled or uncontrolled hypertension.

17. DVT/PE Incidence ConditionsIncidence VTE* No contraception5-10 High dose OCP24-50 Low dose OCP12-20 Third gen OCP9-21 Pregnancy60-70 *Incidence per 100,000 women per year Sulman LP et al.The truth about oral contraceptive and VTE.Journal of reproductive Medicine.2003;48:930-938

18. CVD: DVT & PE CHC- Hx of DVT/PE NOT on anticoagulant Higher risk of recurrence Estrogen associated Pregnancy associated Idiopathic Thrombophilia Cancer Hx recurrence Lower risk for recurrenc- 4 3 Medical Eligibility Criteria for Contraceptive Use (www.who.int/reproductive-health)

19. CVD: DVT & PE Acute DVT/PE- DVT/PE on anticoagulant for at least 3 months Higher risk of recurrence- Thrombophilia Cancer Recurrence Lower risk of recurrence- No risk factors 4 4 3 Medical Eligibility Criteria for Contraceptive Use (www.who.int/reproductive-health)

20. DVT/PE POC’S- History or acute- On or off anticoagulant/Major surgeries/immobilized/Thrombotic mutations- Family History/ Superficial thrombosis- IUD’s Cu: LNG: C2 Acute DVT/PE: C2 both Known thrombogenic mutation- 2 2 2 1 Medical Eligibility Criteria for Contraceptive Use (www.who.int/reproductive-health)

21. Heart disease WHO Classification of risk from contraceptive use and pregnancy in cardiovascular disease WHO ClassRisk for contraceptive method by cardiac condition Pregnancy risk by cardiac condition WHO 1 Always useableRisk no higher than general population WHO 2 Broadly useableSmall increased risk; advantages of method generally outweigh the risk Small increased risk of maternal mortality and morbidity WHO3 Caution in useRisk usually outweigh advantages of method.other methods preferable.* Significant increased risk of maternal mortality& morbidity WHO4 Do not useMethod contraindicated;accepts unacceptable health risk Pregnancy contraindicated.#

22. Think? Safety and efficacy both are important. 1 st -whether COC is safe 2 nd -Which POC’s may be recommended 3 rd -whether there is risk of endocarditis/hemodynamic collapse/hematoma formation Level of contraception desired Women’s lifestyle Efficacy of method should also be considered.

23. Counselling Must present all the suitable options to the patients. Benefits and risks of contraception Risk of pregnancy versus risk of use of contraception.

24. Heart disease and contraception

25. Contraception MethodValvular heart disease: uncomplicated Valvular heart disease: complicated Ischemic heart disease* CHC’S244 Progesterone only11I-2/C-3, DMPA/NE-3 # IUCD121 LNG(I-2/C-3) Barrier11/2†1 SterilizationCSCurrent - D H/O CAD - C Emergency contraception 2 WHO Risk Category 2009

26. Heart disease &Contraception Heart disease &Contraception Intrauterine devices are not indicated in patients at risk for endocarditis, valvular prostheses, or receiving chronic anticoagulation. Hormonal contraception :thrombosis -15% in cyanotic patients Interaction between OCP and anticoagulants (warfarin). Interaction between Bosentan and POPs. ?Parenteral contraception(Mirena) - low profile of complications.

27. Heart 2006

29. IUD’s& pulmonary vascular disease Cardiovascular risk is confined to the time of insertion,in particular to instrumentation of the cervix.vasovagal reaction (5%) may cause potentially fatal cardiovascular collapse in patients with pulmonary vascular disease. To reduce the risk,use of paracervical block / combined spinal & epidural recommended for women with pulmonary vascular disease Implanon is to be preferred Heart 2006;92:Sara Thorne et.al,Risks of contraception and pregnancy in heart disease

30. Congenital heart disease and conraception

31. DYSLIPIDEMIA No need to measure lipid levels prior to prescribing CHC’s unless a woman has known dyslipidemia, other CVD risks (eg, smoking, diabetes, obesity, hypertension), or history of pancreatitis Oestrogen usually increase HDL and decreases LDL.In contrast progestins decreases HDL and increases LDL & total cholesterol. Pills containing desogesterol norgestimate & gestodene improve HDL/LDL ratio. Bushnell CD.Oestrogen and stroke :assessment of risk.Lancet neurol.2005;4:743-751

32. SLE & CONTRACEPTION Positive or unknown antiphospholipid antibodies -CHC- C4,POC-C3,IUD-CU-C1,LNG-C3. Severe thrombocytopenia-CHC-C2,POP-C2,PIC’S-C3,CU-IUD- C3 Immunosuppression- All are C1/2. ACOG recommends that estrogen-containing contraceptives not be used by women with SLE and a history of vascular disease, nephritis, or presence of antiphospholipid antibodies. Progestin-only methods, barrier methods and IUD are appropriate methods for these women. Culwell KR,Curtis KM et al.Safety of contraceptive method use among women with SLE; Obstetrics and Gynecology,2009,114.

33. Neurologic disease CHC’S Headache Not migraines: Initiate: C1 Continue: C2 Migraines: No aura <35 years old Initiate: C2 Continue: C3 > 35 years old Initiate: C3 Continue: C4 Migraines: with aura, Initiate or continue: C4 Any new headache or marked change in Headaches should be evaluated

34. ACOG guidelines state that CHC’s may be used by women with migraine headaches who do not have focal neurologic symptoms, do not smoke, are otherwise healthy, and are younger than age 35. POC’s are appropriate options for women with migraine with aura who have no other risk factors for stroke (eg, smoking, hypertension). IUDs may be used by women with migraine with or without aura. Barrier methods are preferred in migraine patients with aura

35. Headache Aura Migraine CHC’s HeadacheYes No I-C1 C-C2 Age<35Age≥35

36. Epilepsy CHC’S,POP, IUD-C1 Watch drug interactions For patient on- phenytoin,carbamazepine,barbiturates,primidone,topiramate, oxcarbamazepine CHC’S & POP’s -C3 DMPA-C1 NE & Implant -C2 IUD’S-C1 Lamotrigine-levels decrease significantly during COC (C3)use and increase significantly during pill free interval but no drug interactions have been reported with POP(C1) use. valproic acid, gabapentin, tiagabine, levetiracetam, vigabatrin and zonisamide does not appear to decrease serum levels of contraceptive steroids in women using combination oral contraceptives Reimers A, Helde G, Brodtkorb E. Ethinyl estradiol, not progestogens, reduces lamotrigine serum concentrations. Epilepsia, 2005, 46:1414-1417 1

37. No evidence that combination hormonal methods increase the frequency of epileptic seizures use of DMPA has been found to reduce seizure frequency in women with seizure disorders. Vessey M et.al.Oral contraception and epilepsy: findings in a large cohort study. Contraception 2002;66:77-79

38. STROKE CHC’s-C4 POC’s-POP&Implants-I-C2,C-C3: DMPA/NE-C3 IUD’s-CU-C1,LNG-C2 Sterilization-Caution Concern with LNG IUD and PIC’s lies with theoretical concerns over lipid changes Inconsistent findings on POC and thrombosis

39. Multiple sclerosis no progression and possible amelioration of MS during combination hormonal contraceptive use.Progestin-only contraceptive methods, barrier methods and IUDs are also appropriate options for women with MS Holmqvist P, Wallberg M, Hammar M et al. Symptoms of multiple sclerosis in women in relation to sex steroid exposure. Maturitas 2006;54:149-153

40. Psychiatric disorders Depressive disorders Category 1 No data on bipolar or postpartum disorders no clinical evidence that concomitant use of combination oral contraceptives and fluoxetine affects the safety or efficacy to either agent Koke SC, Brown EB, Miner CM. Safety and efficacy of fluoxetine in patients who receive oral contraceptive therapy. Am J Obstet Gynecol 2002;187:551-555

41. VAGINAL BLEEDING

42. Endocrine disorders CHC’s H/O GDM-C1 Nonvascular disease- non-insulin dependent-C2 insulin dependent-C2 Nephropathy/retinopathy/neuropathy-C3/4 Other vascular disease or diabetes of >20 years duration-C3/4

43. Tye1/2 Diabetes – Nonvascular disease C2 vascular disease- type1/2 Diabetes Diabetes of >20 years duration C3/4 CHC’s

44. Combination oral contraceptives Data is limited to short-term studies Low-dose estrogen and less androgenic progestins may have less effect on the diabetic control and lipids No evidence of a negative effect on diabetic sequellae in women with type 1 diabetes No studies in women with type 2 diabetes Cagnacci A, et alContraception. 2009 Jul;80(1):34-9

45. POC’s H/O GDM-C1 Nonvascular disease-C2 Nephropathy/retinopathy/neu ropathy- POP& implants - C2,DMPA/NE-C3 Other vascular disease/diabetes of >20 years duration- POP& implants -C2,DMPA/NE-C3 IUD’s H/O GDM-C1 Nonvascular disease- non-insulin dependent/ insulin dependent- CU- C1,LNG-C2 Nephropathy/retinopathy/neu ropathy,Other vascular disease or diabetes of >20 years duration- CU-C1,LNG- C2 Nelson AL et al.Intermediate –term glucose tolerance in women with history of gestational diabetes :natural history and potential associations with breast feeding and contraception:American journal of Obstetrics &Gynecology,2008;198.

46. Diabetes Mellutus progestin-only contraceptives Injectable DMPA is associated with unfavorable changes in insulin resistance and glucose control Oral progestin (norethindrone) can be used based on available data IUD Levonorgesterel IUD has been avoided due to limited data, however, recent studies demonstrated its safety in diabetic women Copper IUD is metabolically neutral Rogovskaya S, et al.Obstet Gynecol. 2005 Apr;105(4):811-5. Xiang AH, et al.Diabetes Care. 2006 Mar;29(3):613-7.

47. Diabetes ACOG recommends- use of CHC’s in women with diabetes should be limited to non- smoking, otherwise healthy women who are younger than 35 and have no evidence of hypertension, nephropathy, or retinopathy. For women with diabetes, with or without vascular disease or hypertension use of intrauterine contraceptive devices (IUDs) or progestin-only contraceptive methods or barrier methods is not contraindicated.

48. Gastrointestinal conditions Cirrhosis CHC’S-Mild: C1,Severe: C4 POC’S-Severe-C3 IUD’S- Mild, C1 Severe: LNG: C3 Cu: C1 Viral Hepatitis CHC’S/POC’S Acute: C3/4 (with severity) Chronic/carrier: C1 IUD-C1 Hormonal contraceptive use has no /minimal effect on chronic hepatitis or its sequelae. Nathelie et al.Effect of hormonal contraceptive use among women with viral hepatitis or cirrhosis of liver;a systematic review. Contraception2009;80:381-386

49. Gallbladder disease CHC Asymptomatic: C2 Symptomatic-surgery: C2 Medical treatment: C3 POP’S-C2 IUD- Cu: C1 LNG: C2 Cholestasis CHC Pregnancy related: C2 COC related: C3 POC’S-COC-related cholestasis C2 Inflammatory bowel disease (USMEC) CHC’s-Category 2/3 POP, DMPA: C2 Implants: C1 IUD- C1 Depends on risk for VTE

50. Malignancies Gestational trophoblastic disease  Decreasing or undetectable beta HCG-IUD’S are C3.  Persistently elevated betaHCG/Malignant disease-IUD’S are C4 CHC’S & POP’s are safe

51. Liver tumors CHC’S Benign  Focal nodular hyperplasia: C2  Hepatocellular adenoma: C4 Malignant : C4 POC’s-C2/3 IUD’S: Cu: C1 FNH: LNG: C2 Adenoma, hepatoma: LNG: C3 Hormonal contrceptive use in patients with FNH does not influence prolression or regression of liver lesion. Nathalie et al.Hormonal contraceptive use in women with liver tumors.Conraception2009;80,387-390

52. Breast diseases CHC’S,POC’S&LNG-IUD- Undiagnosed mass, benign breast disease,Family history of cancer-C1/2 Breast cancer- Current –C4 Past & no evidence of current disease for 5 years-C3 Evaluation should be persued as early as possible Gaffield ME,Culwell KR et al.Oral contraceptives and family history of breast cancer. Contraception,2009;69:372-380 Cu IUD is category 1 in patients with breast cancer

53. Ovarian Cancer Reduced risk of ovarian cancer among users of all formulations of oral contraceptives regardless of content or potency. Barrier and Hormonal contraception are safe. IUD’s-I-C3,C-C2 Joellen et al.Effect of estrgen and progestin potency in oral contraceptive on ovarian cancer risk Journal of national cancer institute2002;94. WHO Risk Category 2009

54. ENDOMETRIAL CANCER IUD’S-C4 for initiation and C2 for continuation CHC’s,POP’s & barrier method are safe. COC use reduces the risk of developing endometrial cancer and have no effect on growth of fibroids. Uterinefibroids with distortion of cavity- LNGIUD-C4 WHO Risk Category 2009

55. Cervical cancer IUD’s- C4 for initiation and C2 for continuation CIN-POP-C1 Implants &DMPA-C2 Barrier method-cap should not be used Among women with persistent HPV infection,long term DMPA use (≥5 years)may increase the risk of carcinoma in situ and invasive carcinoma Smith JS.Cervical cancer and use of hormonal contraception:a systematic review.Lancet,2003, 361:1159-1167

56. Drug interactions Antiretroviral therapy DrugCHCPOCIUD*Barrier NRTI11 CU-I-C2/3 C-2 LNG-I- C2/3,C-C2 Spermicide & Diaphragm C3 NNRTI22 DMPA-1 Ritonavir boosted protease inhibiter 3POP-3 DMPA-1 Implant--2 *AIDS as a condition is classified as category 3 for insertion &category 2 for continuation

57. Drug interactions Antimicrobial therapy

58. Patient with disability Must take into account-  nature of method,  nature of method &  expressed desire of the individual. Barrier method may be difficult for patient with limited manual dexterity,COC’S may not be preferable for patients with impaired circulation. Patient’s with mental health disabilities who have difficulty remembering to take daily medications,contraception other than OCP’S should be preferred.

59. Modifications Additions VTE Valvular heart disease Ovarian cancer Uterine fibroids Postpartum Breastfeeding RA Bariatric surgery Peripartum cardiomyopathy Endometrial hyperplasia IBD Solid organ transplant CDC Changes from WHO MEC CDC, MMWR, May 28, 2010

60. ACNE Estrophasic(Estrostep)- Combines low dose of progestin with gradually increasing dose of estrogen Marked increase in SHBG,Very low androgen.

61. Sickle cell disease DMPA may be a particularly appropriate contraceptive for women with sickle cell disease American College of Obstetricians and Gynecologists. Use of hormonal contraception in women with coexisting medical conditions. ACOG Practice Bulletin number 73. Obstet Gynecol 2006;107:1453