Contraception

1. Contraception Dr Arlene Smalls, MD August 5, 2011 Lankenau Medical Center Department of OB GYN

2. Objectives of Lecture: • Review of Contraceptive Counseling, Risk Assessment and Method Initiation • Discussion of Conceptive methods including Emergency Contraception • Discussion of new Guidelines regarding Contraceptive Usage

3. Contraception Needs in US • ~60 million women between ages of 15-44 • 60% use contraception • 33% don’t have a need for contraception • 7.3% who are at risk are not using any method • 6 million pregnancies yearly in US • 50% of pregnancies are unintended • 1 million pregnancies occurred on OCP’s • 1.4 million abortions performed yearly in US

4. Counseling • Efficacy • Availability • Costs • Ease of Use • Privacy • Reversibility • Side Effect and Medical Risks • Patient and Partner Desires • Informed Decision Making

5. Contraceptive Efficacy • Pearl Index: • Theoretical Definition of Method Failure Rate based on “Perfect Usage”: Number of Failures / 100 Women-years of exposure (x1200 if based on months) (x1300 if based on cycles) • “Typical or Usage Failure Rate” based on actual usage activity from Life Table Method

6. Contraceptive Methods Combined Hormonal Methods (COC) • Oral Contraception • Nuva Ring • Ortho Evra Patch Progestin Only Methods (POP) • The Mini Pill • Depo-Provera • Implanon Non Hormonal Contraception - IUD Barrier Methods • Male / Female Condoms Sterilization Emergency Contraception

7. Pre-Assessment & Evaluation • Discussion of Patient’s Life and Health Plans • Reproductive Life Plan • Childbearing Goals • Birth Spacing • Pre-conceptual Health Assessment and Counseling • Extensive Personal Medical History and Family History

8. Pre-Assessment History • Personal History: • Medical History of Hormonal contra-indications: (HTN, MI, Cardiac Dz, DM, CVA, DVT, PE, other) • Liver Disease • Migraine headache with aura or neurologic complaints; Seizure history • Tobacco Usage • Current Medications • Surgical History

9. Pre-Assessment History • Gyn History: • Menstrual History including LMP • Breast Issues including new or unevaluated masses • Uterine fibroids or other anatomic abnormalities • STD history, prior and current risk (?) • Familial History of Thrombophilia (1st degree relative)

10. Pre-Assessment & Evaluation • Physical Exam not necessary prior to initiation of any birth control method • Vital Signs, Weight • Breast Exam*, Pelvic Exam (??) • Laboratory Testing • Factor V Leiden, Anti-phospholipid evaluation, Glucose, and Lipids if there is a concerning personal or family history • STD screening prior to IUD placement (?)

11. CDC and Contraception Medical Eligibility • WORLD Health Organization (WHO)established an evidence based guideline for contraceptive usage • Global review of the 19 different contraceptive methods for women and men • 4th version was revised 2010 (available since 1996)

12. COC Physiologic Effects • Hormonal Effect • Estrogen (ethinyl estradiol) and Progesterone alter FSH/LH secretion via negative feedback • Follicle development and Ovulation are suppressed • Endometrial thinning • Cervical mucous thickening • Reduced sperm transport • Progestin is the dominant hormone

13. COC or OCP’s • 10.7 million women use OCP (~27% of BC users) • Most popular, reversible BCM in the US • 21 day cycle, 24 day cycle • Extended regimens • Monophasic, Biphasic, Triphasic, Quadiphasic (Quailara@) • 20mcg, 35 mcg, 50 mcg pill regimens (based on Estrogen dosage)

14. OCP Failure • Failure rate is 0.1% • Usage Failure rate is 8/100 woman-years • Adherence with OCP – 50% of women miss 1-3 pills a cycle • Missing Pills within the 1st week of the pack – breakthrough ovulation • Drug Interactions – • Anti-seizure medications (G450 activation) • Antibiotics – Rifampin, Griseofulvin • Anti-viral medications - Norvir

15. OCP’s concerns • Alterations in the Menstrual Cycle • Breakthrough bleeding • Amenorrhea 0.8% per year • Health Risks • Headaches and Elevated Blood pressure • Weight Gain • Breast Cancer risk • Risk of Thrombo-embolic events*

16. Non Contraceptive Benefits • Acne and Hirsuitism therapy • Menstrual Regulation occurs with decreased Menstrual Blood Loss • Dysmenorrhea, endometriosis symptoms are improved • Rates of Ovarian cysts, ectopic pregnancy, and salpingitis are reduced. • Ovarian and Endometrial Cancer rates are reduced with past usage of at least one year

17. Contra-indications to COC usage • Medical History • Personal H/o Thrombo-embolism (DVT, PE, CVA, MI) or Familial History of inherited thrombophilia (DVT, PE, CVA, MI) • Uncontrolled HTN (>160/100) • Hepatic Dysfunction • Diabetes • Breast Cancer • Smokers over the age of 35** (#) • Unexplained vaginal bleeding or Pregnancy

18. Contra-indications to COC usage • Postpartum patients* <21 days, • Cardiac Disease including h/o ischemic heart disease, valvular heart dz, peripartum cardiomyopathy and multiple risks factors for heart disease* • H/o Solid Organ Transplant, complicated • H/o Gastric Bypass* CDC – Medical Eligibility Criteria, 2010

19. Pos tpartum Contraception • WHO Revised guideline 7/2011 • PP, 22-84X greater risk of DVT, PE or VTE • Ovulation can occur as early at 25 days in non lactating women • 21 days pp - No COC or CHC • 42 days pp – Non COC or CHC • Obesity, Post Cesarean Delivery, Preeclampsia, PP hemorrhage, Transfusion at Delivery, Immobility, Age > 35, Tobacco Users, BMI > 30, Prior h/o VTE, Thrombophilia) • POP methods are acceptable immediately

20. Drug Interactions and OCP’s • Anti-Malarial Meds: Rifampicin / Rifabutin • Anticonvulsant Medications: Lamotrigine* Phenytoin, Carbamazepine, Barbituates, Primidone, Topiramate and Oxcarbazepine • Antiretroviral therapy (ARV): Ritonavir-boosted protease inhibitors

21. Ortho-Evra • Weekly Transdermal patch of a hormonal matrix • 150 mcg ethinyl estradiol • 20 mcg norelgestromin • Worn 3 weeks out of 4 weeks per cycle • Sites of usage: Back, Upper arm, Abdomen, or Chest • Sunday Start or 1st day Start • Patch Change Date within 48 hours of scheduled date • Failure rate: 1% • Not recommended for hormonally naïve patients, smokers*, or patient with h/o skin sensitivity or weights above 198 lbs

22. NuvaRing • Ethylene vinyl acetate polymer ring • 15 mcg of Ethinyl estradiol • 120 mcg Etonogestrel • Intra-vaginal placement • Worn ¾ weeks per cycle with option of one week • Menstrual Cycles regulated 98.5% of cycles • Failure rate: 0.65-1.18/100 women-years • Vaginal Discharge and placement issues

23. Progesterone only Contraception • Progestin-only pills - POP or “Mini pills” Norethindrone or norgestrel • Continuous usage (no pill free interval) • Hormone must be taken daily at the same time (25% circulating levels of OCP’s / 22hr effect) Ovulation seen in 40-50% of POP users • Mechanism of action: Cervical Mucous thickening, Thinning of endometrium, reduced sperm transport • Failure Rate: 1.1 to 9.6 / 100 women-years • Backup method – Barrier Method / Breast feeding

24. Depo-Provera@ or DMPA • 150milligrams of Medroxyprogesterone acetate • IM dose every 11-13 weeks • Deltoid or Gluteus Maximus • Inhibits LH/FSH surge • Ovulation and endometrial proliferation are inhibited • New Guidelines regarding missed doses • WHO 2009 – Delayed Dosages can be given up to 4 weeks from date originally scheduled • Failure Rate: 0.3 – 3% • Long lasting but reversible • Return to fertility – 50% by 9 months (max – 18 months)

25. DMPA • Contra-indications: • Breast Cancer • Safe if contra-indications to COC’s exist: • Tobacco, HTN, • SLE, CVA, Thromboembolic events (DVT/PE), Liver Disease (????) • Improved Outcomes in Certain Populations: • Sickle Anemia / Trait; Seizure Disorder • Endometriosis, Dymenorrhea and Pelvic Pain • Adolescents, Developmentally Delayed Women

26. DMPA Risks • Bone Density alteration due to estrogen deficiency • Limited Risk: Bone changes resolve with cessation of DPMA • Menstrual Changes • 70% have increased bleeding days per month • 75% experience amenorrhia after one year of usage • Weight Gain • More in Women who are Obese at initiation of method • 5lbs by year One; 16 lbs by year Five • Mood Disorders and Psychiatric Issues

27. Implanon • Subdermal, single rod progestin implant • Etonogestrel release • 3 year duration of use • Ovulation suppression and endometrial thinning • Failure rate: no failures reported in 4103 women / 70,000 cycles • Menstrual pattern alteration – 80% • Irregular or prolonged bleeding (3-5 days per cycle) • Total Overall Blood loss decreased • Treat with NSAIDS, OCP’s or estrogen

28. Intra Uterine Device – Paraguard@ IUD • Long acting, low maintenance, rapidly reversible contraception • Copper T380A - 3.6cm long T shaped device made of polyethylene plastic • Length of usage – 10-12 years • Prevention of pregnancy via Endometrial inflammatory response and anti sperm activity • Failure rate = 0.8% (up to 3% at 10 years) • Risk of PID, Expulsion/perforation at insertion and Dysmenorrhea/Menorrhagia

29. Mirena@ IUD • 3.2cm long, T-shaped device with an inner reservoir • Levonorgestrel 20 mcg per day • Cervical Mucous thickening and Endometrial atrophy • Ovulation still occurs in 85% of the cycles • Failure rate: 0.14 per 100 women–years 0.71% (5 year failure rate) • Menstrual irregularity during the first three months • Menorrhagia/Endometrial Cancer treatment

30. IUD Safety • Safe Profile proven with recent studies • Safe for Adolescents and Nulliparous Females • Limited increased risk of PID/Infection within the first 30 days post placement • Screen for STI and BV pre-placement if Risk factors • Treat STI and allow 3 months from therapy prior to IUD placement • Recommend Condom usage • IUD can be left in place if cervicitis or PID diagnosed

31. Barrier Methods • Male Condoms • Latex condoms – STI protection • Failure rate – 3% (Actual – 12%) • Breakage rates: 1% of heterosexual acts • Nonoxynol 9 no longer recommended • Polyurethane or Non latex condoms • Female Condoms • Polyurethane pouch with two rings • Can insert up to 8 hours prior to intercourse • Female controlled and allows Labia protection

32. Barrier Methods, Other • Cervical Cap: • Thimble shaped rubber device that fits over the cervix • Fitted by gynecologist • Can be left in vagina for 48 hours • Vaginal Discharge • Failure rate: 9% in nulliparous; 20% in parous within 1 year • Diaphragm: • Dome shaped rubber cups create a barrier over the cervix • Use with spermicide • May place in vagina up to 6 hours prior to intercourse and remain in place for 8 hours (max 24 hours) • Failure rate: 6% / 12% • UTI risks

33. Permanent Sterilization - Female • Female Sterilization is the most common method used in US for married couples • 10 million women in US • 100 million women worldwide • Overall Failure rates: 1.85% over 10 years but differs slightly by method and provider experience • Drawbacks: Regret, Failures, Ectopic pregnancy (CREST study – NEJM 2001)

34. Permanent Sterilization - Female • Laparoscopic Methods: Bipolar Cautery, Sialastic Bands / Falope Ring, Filshie or Hulka Clips, • Open Procedure / Minilaparotomy: Pomeroy/Modified Pomeroy, Parkland, Irvine, Uchida, Fimbrectomy • Hysteroscopic Methods: Essure, Adiana

35. Male MethodsSterilization - Vasectomy • Conventional Vasectomy • “No Scapel Vasectomy” - In Office Procedure for occlusion of the Vas Deferens • Limited Risks: • No Missed Work, Minimal Pain • Need 2 negative Sperm Analysis • Costs: $350 – $1,000 • Failure Rate: < 1% • Reversibility:

36. Emergency Contraception – “EC” Post coital Contraception - Pregnancy prevention • Yuzpe method, 1970’s • 100mcg estrogen/500mcg Levonegestrel - (2) doses in 12hrs • Drawbacks: nausea, vomitting • More than 20 brands of OCP can now be used as EC* • Reduction in unintended pregnancy rates post EC: 95% if taken with 12 hours; 89% if taken with 5 days • IUD

37. Emergency Contraception – “EC” • Plan B, available since 2000 • 1.5mg Levonorgestrel • Single dose (2 pills) versus 2 One pill dose protocol every 12hrs • Available over the counter (Age >17) since 2009 • Well tolerated • Next Choice- progestin only EC, OTC available since 2010

38. Emergency Contraception – “EC” • Reduction in unintended pregnancy – 95% if taken with 12 hours; 75% if taken within 72 hours May use EC up to 120 hours after intercourse* • If, no menses within 2-4 weeks or persistent irregular bleeding post EC, rule out pregnancy

39. Contraceptive Method Initiation • Quick start, Sunday start, Menses Day 1 start • LMP to r/o pregnancy needed with Quick start • Backup needed for 7 days after initiation – Quick start and Sunday start • Altered Menses may be seen with all methods • Combination methods – Important • Condoms/Barrier methods with hormonal method • Emergency Contraception • Postpartum

40. Pos tpartum Contraception • WHO Revised guideline 7/2011 • PP, 22-84X greater risk of DVT, PE or VTE • Ovulation can occur as early at 25 days in non lactating women • 21 days pp - No COC or CHC • 42 days pp – Non COC or CHC • Obesity, Post Cesarean Delivery, Preeclampsia, PP hemorrhage, Transfusion at Delivery, Immobility, Age > 35, Tobacco Users, BMI > 30, Prior h/o VTE, Thrombophilia) • POP methods are acceptable immediately

41. Adolescents • Confidentiality Issues • Recommend Informed Adult regarding medication • Return office appt for contraception re-enforcement and assessment

42. Resources • U.S. Medical Eligibility Criteria for Contraceptive Use, 2010 www.cdc.gov/mmwr/pdf/rr/rr59e0528.pdf • World Health Organization http://www.who.int/en/ • Guttmacher Institute www.guttmacher.org/pubs/psrh/full/3809006.pdf