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COCs – Current Concepts and Practices

COCs – Current Concepts and Practices . Dr. Alka Kriplani, Professor, Head – Unit II Dr. Deepa Maheswari, Senior Resident Department of Obst. & Gynae. AIIMS, New Delhi. Need for contraception…. World’s population expected to reach 9 billion by 2050.

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COCs – Current Concepts and Practices

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  1. COCs – Current Concepts and Practices Dr. Alka Kriplani, Professor, Head – Unit II Dr. Deepa Maheswari, Senior Resident Department of Obst. & Gynae. AIIMS, New Delhi

  2. Need for contraception…. • World’s population expected to reach 9 billion by 2050. • India accounts for 17% of world’s population. Wikipedia, The Free Encyclopedia

  3. Need for contraception…. • Annually, 529,000 maternal deaths & 50 million morbidity. • In India, contraceptive prevalence is 48.3% • 21% of all pregnancies resulting live births are unplanned. • If unmet need for contraception was met, we can avoid • 52 million unwanted pregnancies • 25-50% of maternal deaths Hindin MJ, Lancet. 2007;370:1297-8.

  4. Contraceptive measures would… • Slow the pace of population growth • Decrease abortion related complications and deaths • Cut down maternal care costs • Promote better maternal health • Improve the health of children through provision of better nutrition and other care ……..beneficial to the society at large!!! Population reference bureau, Washington, USA, Nov 2004

  5. Certain terminologies…. • Fertility control or family planning: Limitation of pregnancy & family size, hence control of population. • Contraceptive efficacy: • Pearl index – pregnancy rate per 100 woman years = total accidental pregnancies X 1200 Total months of exposure to unintended pregnancies • Life table technique – calculates failure rate for each month of use. Cumulative failure rate can compare methods for specific length of exposure

  6. Contraceptive failure • Method effectiveness • Correct use of method under ideal conditions • Lowest expected failure rates • Use effectiveness – typical failure rates • Due to incorrect use of method • Human errror

  7. Methods of contraception • Natural methods • Hormonal contraception • Oral • Non-oral • IUCD • Barrier methods • Sterilization • Emergency contraception

  8. Hormonal contraception • Oral contraceptives • Combined pills (COC) • Progesterone only pills (POP) • Non oral hormonal contraception • Injectables • Implants • Vaginal rings • Transdermal patch • Hormonal IUCD • Emergency contraception

  9. Combined oral contraceptives • Monophasic pills : High dose pills, >50μg EE Low dose, 30μg EE Ultra low dose, 20μg EE • Multiphasic pills : Biphasic or Triphasic • Sequential pills

  10. EVOLUTION OF THE PILL

  11. Estrogens in newer COCs • Trying to reduce the dose of estrogen to the lowest possible without reducing efficacy • Study- 15μg EE + 60μg gestodene for 24/4 days: effective, safe, well tolerated, good cycle control Barbosa, Contraception. 2006

  12. Progestins in newer COCs • Reducing the dose to the lowest possible without reducing efficacy (10 fold reduction) • Newer progestins • Less androgenic • Negligible impact on carbohydrate and lipid metabolism • Potent inhibitors of ovulation - ↓estrogen dose • Can be used in treatment of acne and hirsutism

  13. A comparison of various progestins

  14. Drospirenone, the ideal progestin?

  15. Monophasic pills

  16. Multiphasic COC • Comparable in efficacy to monophasic pills • It was introduced with an aim of reducing the total dose of hormones per cycle and to ↓ BTB. • But no clinically significant difference in adverse effects & continuation rates were found.

  17. Extended regimen COC • Shorter hormone free interval, Similar efficacy. • ↓Escape ovulation, ↓ovarian activity. • ↓ Mid cycle break through bleeding. • ↓Pelvic pain, breast tenderness, bloating, swelling (hormone withdrawal symptoms). • Useful in perimenopausal women with vasomotor symptoms on pill free days. • NETA 1mg/ EE 20 μg 24d Vs 21d – Effective, well tolerated, better bleeding profile. Nakajima, contraception, 2007

  18. Continuous use of combined pills • ↓Dominant follicle formation/ breakthrough ovulation • Discontinuation - More delay in ovulation Rebecca L, contraception. 2006 • Studies have described continuous use upto 1 year. • Comparing continuous daily 90μg LNG + 20μg EE Vs 21 day cyclic 100μg LNG + 20μg EE • Similar of adverse effects and efficacy. • ↓ Breakthrough bleeding & intermenstrual spotting Alexander T, Contraception. 2006

  19. Seasonale • Available since 2003 • 150µg of LNG + 30µg of EE • Taken continuously for 84 days, break for 7 days • Fewer periods (4 in a year) • Pearl index- 0.78 • Breakthrough bleeding/ spotting – First few cycles

  20. Drospirenone containing COC • Drospirenone: Spironolactone analogue • Eg: Yasmin (30µg of EE and 3mg Drospirenone, 21/ 7 regimen) • Pearl index 0.4 • 24/4 regimen also well tolerated (20µg EE + 3mg DSP) Bachmann G, Contraception. 2004 • Extended 126 day regime – Efficacious, safe, ↓bleeding Foidart, Contraception. 2006 • Contraindications – hepatic & renal dysfunction, adrenal insufficiency, thromboembolic disorders.

  21. Drospirenone containing COC: Advantages • Does not result in wt gain or increase in BP • Does not cause acne or seborrhea • Decreases symptoms of PMS • Decreases hirsutism • Improves lipid profile • Does not adversely affect glucose metabolism • Does not adversely affect BMD • No significantly higher risk of VTE Vs other OCs

  22. Minor side effects of COCs Due to estrogen • Nausea, vomiting, loss of appetite • Breast changes • Vaginal discharge • Headache and migraine • Chloasma Due to progesterone • Psychosexual problems • Acne and oily skin • Oligomenorrhea & amenorrhea Others • Break through bleeding (Due to low estrogen) • Weight gain (due to E +P)

  23. Major side effects of COCs Due to estrogen • Venous thromboembolism • Ischemic stroke and MI • Cholestasis, GB disease • Hepatic adenoma Due to progesterone • Modest increase in BP • Altered lipid metabolism: ↑LDL cholesterol, ↓HDL cholesterol • Derangement in carbohydrate metabolism

  24. CHECKLIST FOR PRESCRIBING COCs • Last menstrual period, rule out pregnancy • Less than 6 months postpartum & lactating? • Age, Cigarette smoking, h/o migraine • Known case of diabetes or hypertension • History of stroke, MI or thrombosis • h/o jaundice/ liver disease • h/o breast/ genital tract malignancies • h/o drug intake: Antiubercular, antiepileptic

  25. Myths about hormonal contraception

  26. ??? aa

  27. Scared !!!

  28. Clear the confusion !!! Cancers and COCs • Carcinoma endometrium – protective !!! • Use of COC for 12 months: 50% risk reduction • Protection persists 20 yrs after discontinuation Weiderpass E, cancer causes control.1999. • Epithelial ovarian cancers – protective !!! • Even 3-6 months use: 40% risk reduction (3 yr use- notable impact, 10 yr use- 80% risk reduction) • protection continues 20 yrs after stopping. Royar J, Int J Cancer. 2001. • Carcinoma liver – no association !!! WHO Colloborative study, Int J Cancer. 1989

  29. Clear the confusion !!! Cancers and COCs • Carcinoma cervix – no definite association !!! • Detection bias due to increased screening with pap smear • No significant increased risk of invasive carcinoma cervix Irwin KL, JAMA, 1988 • Carcinoma breast – controversial, caution !!! • Current use: ↑early premenopausal ca breast, detection bias. • Past use: ↓ incidence metastatic postmenopausal ca breast • Known case of ca breast: COCs are C/I • BRCA1 & BRCA2carriers –50% risk reduction for ca ovary (baseline risk 45% & 25% in BRCA1 & BRCA2 respectively) ACOG Practice bulletin no 18, Obst & Gynecol. 2006

  30. COC & VTE…

  31. COC & VTE, Contd… • Before major surgery with immobilization • Stop COCP before 4 wks • If continuing COCP – Heparin prophylaxis • No need to stop POP • Before minor surgery - Continue COCP/ POP • Varicose veins – WHO 1 (Unrestricted use) • Superficial thrombophlebitis – WHO 2 • Thrombophilia screen before starting COCP • Not recommended as routine • Done if H/o VTE in first degree relative < 45 yrs RCOG, Greentop guidelines 2004

  32. COC & Diabetes… • COC in type I DM – Studies find no change in HbA1c, no change in development or progression of nephropathy or retinopathy • Nonsmoking, <35yrs, otherwise healthy diabetics, no end-organ disease – COC safe • Mirena – Safe in diabetics • Past h/o GDM – COC do not accelerate or precipitate development of type II DM ACOG Practice bulletin no:18, Obst & Gynecol. 2006

  33. COC & Hypertension • COC in HT ↑risk of MI (OR:10.7) & stroke (OR:68.1) • Hypertensive <35yrs, nonsmokers, no end-organ vascular disease, no other cardiovascular risk factors with well controlled HT – COC can be started under careful BP monitoring • Progesterone only methods are safe ACOG Practice bulletin no 18, Obst & Gynecol. 2006

  34. COC & Hyperlipidemias • Estrogen - ↑ HDL & TG, ↓ LDL • Progesterone - ↓ HDL & TG, ↑ LDL • Controlled dyslipidemia – COCP, <35 µG EE, lipid levels monthly after initiation till stabilization • Uncontrolled dyslipidemias (LDL cholesterol >160mg/dl, HDL <35mg/dl, TG> 250mg/dl) or other cardiovascular risk factors – do not use COCP ACOG Practice bulletin no 18, Obst & Gynecol. 2006

  35. More about COCs • No ↑ risk of MI / stroke in healthy non smoking women > 35 yrs on COCP, <50μg EE • Age > 35yrs & smoking, COCP ↑ risk of MI- 2 fold • 2 fold ↑ risk of ischemic stroke in migraine • OCP use & weight gain - No association • Role of COCP on lactation – Data insufficient • Depressive disorders – Not worsened ACOG Practice bulletin no 18, Obst & Gynecol. 2006

  36. Non contraceptive benefits -OCP • Cycle-related: • Irregular cycles, dysmenorrhea, menorrhagia &anemia • Functional ovarian cysts • Prevention of: • Bone loss • Fibrocystic/benign breast disease • Pelvic inflammatory disease (PID), Ectopic pregnancy • Treatment of: • Acne, Hirsuitism • Perimenopausal symptoms Grimes DA,1997, The Contraception Report. Emron.

  37. Use of COCs for emergency contraception Emergency contraception: “Therapy used to prevent pregnancy after an unprotected or inadequately protected act of sexual intercourse.” ACOG practice bulletin no 69, obstet gynecol.2005;106: 1443-51 • Types : Hormonal Oral contraceptive formulations Progesterone preparations Mifepristone Others – estrogens, danazol Mechanical - IUD

  38. Yuzpe regimen • 0.1mg EE + 1mg dl-NG taken within 72 hours • High dose COCP – 2 stat and 2 after 12 hrs • Low dose COCP – 4 stat and 4 after 12 hrs • Side effects: Nausea(50%), vomiting(20%), heavy menstruation, breast tenderness • Prophylactic use of antiemetic 1 hr before first dose • Menstruation within 3 wks of therapy in 98% of pt • No teratogenicity reported • Efficacy: Reduction of 75% in the no. of pregnancies estimated to occur without treatment Trussel J, contraception, 1999

  39. Yuzpe regimen • Levonorgestrel and mifepristone are preferred nowadays due to better side effect profile (less nausea and vomiting) and better efficacy. • Mifepristone is effective upto 120 hours after coitus.

  40. Contraception in special situations • Obesity (BMI > 30) • Transdermal patch, COCP - ↑ Risk of failure • COCP + Obesity - ↑ VTE • DMPA – Failure rates not increased • IUCD appropriate • ↑ Risk of DUB, endometrial hyperplasia - ↓ by mirena • Fibroid uterus • COCP- ↓ MBL & pain, do not ↑ growth of fibroid • DMPA – Amenorrhea, ↓ MBL • Mirena – Beneficial - ↑ Expulsion rate(12%) Mercorio et al, contraception 2003; 67: 277-80

  41. Contraception in special situations • Epilepsy • Enzyme inducers- Studies observe ↓ serum levels of COCP, ↑ BTB, but no ovulation or accidental pregnancy • No published data to support role of COCP with 50μg EE • Non enzyme inducers – Ethosuximide, gabapentin, lamotrigine, levetiracetam, tiagabine, valproic acid, zonisamide • Efficacy of mirena remains high • Use IUCD or COCP + condoms • Inflammatory bowel disease • Disease exacerbation – Immobilisation – Stop COCP • No special recommendations in stable disease

  42. Contraception in special situations • SLE • H/o vascular disease, nephritis or presence of antiphospholipid antibody – Avoid COCP • Stable disease, no antiphospholipid antibodies – Use COCP • Progesterone only methods – Safe • IUCD – Safe, effective • Women on anticoagulant Rx • ↑ Menorrhagia, corpus luteum hematoma, hemoperitoneum • COCP, DMPA, Mirena - Appropriate • COCP – Do not ↑ risk of thrombosis if well anticoagulated • DMPA – Not much injection site problems

  43. Contraception in special situations • Sickle cell disease- DMPA- ↓ Sickling, painful crisis Legardy et al, contraception. 2006; 73: 195-204 • Contraception for HIV positive women • Ideal- Dual method- Mirena + Condom • Condom alone- High failure rate • Cu IUD- ↑ MBL (Infectious morbidity is not increased) • Mirena- Unaltered genital shedding, transmission not prevented • OCP - ↑ Genital shedding Lehtovirta, contraception. 2007

  44. Thanks to all contributors. Dr Adarsh Bhargava. Dr Ashwini Bhalerao. Dr Alka Kriplani. Dr. Kalpana Apte. Dr Mala Arora. Dr.Meenakshi Bharath. Dr. Mandakini Parihar. Dr.Nozer Sheriar. Dr.Parikshit Tank. Dr. Roza Olyai. Dr.Sasikala Kola. Dr.Sujata Mishra.

  45. Thank you

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