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Contraception Dr Arlene Smalls, MD August 5, 2011 Lankenau Medical Center Department of OB GYN 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 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 Counseling Efficacy Availability Costs Ease of Use Privacy Reversibility Side Effect and Medical Risks Patient and Partner Desires Informed Decision Making 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 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 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 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 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) Pre-Assessment & Evaluation Physical Exam not necessary prior to initiation of any birth control method Laboratory Testing Vital Signs, Weight Breast Exam*, Pelvic Exam (??) Factor V Leiden, Anti-phospholipid evaluation, Glucose, and Lipids if there is a concerning personal or family history STD screening prior to IUD placement (?) 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) 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 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) OCP Failure Failure rate is 0.1% Usage Failure rate is 8/100 womanyears 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 OCP’s concerns Alterations in the Menstrual Cycle Health Risks Breakthrough bleeding Amenorrhea 0.8% per year Headaches and Elevated Blood pressure Weight Gain Breast Cancer risk Risk of Thrombo-embolic events* 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 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 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 Postpartum 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 Drug Interactions and OCP’s Anti-Malarial Meds: Anticonvulsant Medications: Antiretroviral therapy (ARV): Rifampicin / Rifabutin Lamotrigine* Phenytoin, Carbamazepine, Barbituates, Primidone, Topiramate and Oxcarbazepine Ritonavir-boosted protease inhibitors 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 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 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 Depo-Provera@ or DMPA 150milligrams of Medroxyprogesterone acetate IM dose every 11-13 weeks Inhibits LH/FSH surge Ovulation and endometrial proliferation are inhibited New Guidelines regarding missed doses Deltoid or Gluteus Maximus 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) 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 DMPA Risks Bone Density alteration due to estrogen deficiency Menstrual Changes 70% have increased bleeding days per month 75% experience amenorrhia after one year of usage Weight Gain Limited Risk: Bone changes resolve with cessation of DPMA More in Women who are Obese at initiation of method 5lbs by year One; 16 lbs by year Five Mood Disorders and Psychiatric Issues 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 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 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 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 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 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 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) 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 Male Methods Sterilization - 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: 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 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 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 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 Postpartum 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 Adolescents Confidentiality Issues Recommend Informed Adult regarding medication Return office appt for contraception re-enforcement and assessment 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