1. NABEEL BONDAGJI, MD, FRCSC CONSULTANT PERINATOLOGIST KFSH&RC - JEDDAH “CONTRACEPTION IN WOMEN WITH MEDICAL DISORDERS”

2. INTRODUCTION Pregnancy spacing or control. Do no harm. Select appropriate method to the appropriate patient. Evidence based medicine with and against evidence. Recommendation - strength of the recommendation.

3. Evaluation of the Evidence Based On: t Evidence obtained from at least one properly designed randomized controlled trial. t Evidence obtained from well-designed controlled trials without randomization. t Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group..

4. (Cont’d - Evaluation of the Studies Based On: t Evidence obtained from multiple time series with or without the intervention. t Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees..

5. Evaluation of the recommendation Based On: t Based on the highest level of evidence found in the data, recommendations are provided and graded according to the following categories: Level A - Recommendations are based on good and consistent scientific evidence. Level B - Recommendations are based on limited or inconsistent scientific evidence. Level C - Recommendations are based primarily on consensus and expert opinion.

6. MEDICAL DISORDERS D.M. D.M. Hypertension Hypertension Venous thrombosis Venous thrombosis Migraine headache Migraine headache Fibrocystic breast changes Fibrocystic breast changes Fibro adenoma Fibro adenoma Family history of breast Ca Family history of breast Ca

7. ( Cont’d) - MEDICAL DISORDERS Hyperlipidemia Hyperlipidemia Sickle cell disease Sickle cell disease SLE SLE Patients who underwent Patients who underwent valvular cardiac replacement valvular cardiac replacement

8. Patients on Medications Anticoagulant therapy Anticoagulant therapy Drugs Drugs Antibiotics Antibiotics

9. D.M. Concerns:CBCP t Theoretically impairment of carbohydrate progesterone component. progesterone component. t Increased insulin and increased glucose t Increase in the peripheral resistance to insulin Progesterone only pills (minipills) Implants Implants DMPA DMPA Same Concern

10. I.U.C.D. I.U.C.D. t Immunity compromised t Increased risk of infection Mechanical barriers methods Mechanical barriers methods Permanent Methods Permanent Methods No major concerns

11. Evidence in D. M. The use of low does BCP did not alter the blood sugar content nor accelerate the complications. Evidence Level II No increased risk in CBCP user to develop DM. Evidence Level II Evidence Level II Progesterone only pills- No conclusive evidence. I.U.C.D. in well-controlled D.M. – No major difference in the risk of infection. Evidence Level II Evidence Level II

12. Recommendations Mechanical barriers Permanent sterilization Low dose CPCP in: t Non-smoker t 35 years old or younger t No hypertension, retinopathy, or vascular disease t Level B I.U.C.D.

13. Hypertension Concerns: CBCP CBCP t Increase in blood pressure 8/6 mmHg t Increased risk of vascular events, increased three (3) fold in hypertensive on CBCP t Increased risk of IHD

14. Minipills t Same concerns I.U.C.D. t No major concerns Mechanical barriers t No major concerns (Cont’d) - Hypertension

15. Recommendations BCP t Women who have: Well-controlled BP 35 years old or younger Non-smoker No end organ damage t Are allowed to have a trial of CBCP for a few months if BP remains controlled to continue. Level B

16. (Cont’d) - Recommendations I.U.C.D. t No contraindication but no compelling evidence of its safety (no major studies) t Mechanical Barriers t Permanent Sterilization

17. Women with Fibrocystic Breast Changes, Fibroderoma, Family History of Breast Ca Concerns: CBCP CBCP t Increased risk of breast Ca, small but not significant t Estrogen component Progesterone pill, implants DMPA Progesterone pill, implants DMPA t No major concerns I.U.C.D. I.U.C.D. t No major concerns

18. Recommendations CBCP CBCP t Women with fibroadenoma or benign breast disease or family history of breast Ca can use CBCP safely. t Level A Progesterone only pill Progesterone only pill t Safe I.U.C.D. I.U.C.D. t Safe Barriers and permanent sterilization Barriers and permanent sterilization t Safe

19. Migraine Headache Concerns:CBCP In women with focal neurological signs four(4) fold increase in ischemic stroke. In women with focal neurological signs four(4) fold increase in ischemic stroke. Risks increase in smokers thirty-four (34) fold. (Level II) Risks increase in smokers thirty-four (34) fold. (Level II) Women with no focal neurological signs, no major increase in risk. (Level II) Progesterone containing BC method – same concern. I.U.C.D. – no major concern. I.U.C.D. – no major concern. Mechanical barriers or permanent sterilization – no major concerns. Mechanical barriers or permanent sterilization – no major concerns.

20. Recommendations CBCP t Contraindicated in patients with migraine headache with neurological signs and can be used in patients without neurological signs, non-smoker, and younger than 35 years old. t To be discontinued if they develop increase in headaches. Level B

21. (Cont’d) - Recommendations I.U.C.D. t Safe Mechanical barriers or permanent sterilization t Safe

22. Patients who have Undergone Cardiac Valvular Replacement Concerns:CBCP t Micro-emboli Estrogen effect I.U.C.D. I.U.C.D. t Risk of SBE Barriers and permanent sterilization Barriers and permanent sterilization t No major concerns

23. RecommendationsCBCP t Contraindicated Level A Progesterone only pill t May be used Level B Level BI.U.C.D. t No evidence to state that increased rate of SBE, therefore, may be used t Level C

24. Patients on Anti-Coagulants Recommendations CBCP CBCP t May be used Level B Level B Progesterone only pill t May be used Level A Level A

25. (Cont’d) - Patients on Anti- Coagulants Recommendations I.U.C.D. t No major data t Can be used Level C

26. Women with Hyperlipidemia Concerns:CBCP t Progesterone component t Increased LDL, decreased HDL t Estrogen component t Decreased LDL, increased HDL Progesterone only pill t Increased risk I.U.C.D. t No effect Mechanical barriers t No effect

27. Recommendations Women with controlled lipid profile may used CBCP. Women with controlled lipid profile may used CBCP. Women with uncontrolled lipid profile should not use CBCP. Women with uncontrolled lipid profile should not use CBCP. Level C Level C Progesterone containing agent, contraindicated Progesterone containing agent, contraindicated Level B Level B I.U.C.D., safe I.U.C.D., safe Level A Level A

28. Women with SLE Concerns:CBCP t Increased flare up attacks t Increased incidence of DVT Level IV Level IV Progesterone only pill Progesterone only pill t No increased risk Level II Level II

29. Recommendations CBCP t To be avoided Level B Level B Progesterone only pill, DMPA, and implants are the methods of choice for SLE patients. Level B Level B I.U.C.D., barrier method, permanent sterilization. t Safe

30. Sickle Cell Disease CBCP t Increased risk of vaso-occlusive crisis crisis Level III Level III t No major evidence DMPA t Decreased incidence of vaso-occlusive crisis crisis Level II Level II

31. (Cont.’d) - Sickle Cell Disease I.U.C.D. t No major concerns t No data Mechanical and permanent t Safe Level II

32. Recommendations CBCP t To be avoided Level C Level CDMPA t To be used Level B Level B

33. Patients with History of Venous Thrombosis Venous Thrombosis Concerns: CBCP t Increased risk of venous thrombosis four (4) fold than non-users. t Mainly the estrogen component. Progesterone only pills t No major concerns

34. (Cont’d) - Patients with History of Venous Thrombosis Venous Thrombosis Concerns: Mechanical barriers or permanent sterilization. t No major concerns MPA and implants (hematoma) I.U.C.D. menorrhagia in patient on anti- coagulant therapy

35. Recommendations CBCP t Contraindicated except during anti- coagulation therapy Level A Progesterone only pills t Recommended in patients with VTE Level A DMPA implants should be avoided Level A

36. (Cont’d) - Recommendations I.U.C.D. t Can be used in patients who are off anti- coagulation therapy t May be used during anti-coagulation therapy provided that patient does not develop significant menorrhagia Mechanical barrier and permanent sterilization methods allowed.

37. Thank You..