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Contraceptive Update. Lydia D. Nightingale, MD, FACOG University of Oklahoma Health Sciences Center Department of Obstetrics and Gynecology October 23, 2013. Objectives. I have no financial relationships to disclosure At the end of this lecture you will be able to discuss
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Contraceptive Update Lydia D. Nightingale, MD, FACOG University of Oklahoma Health Sciences Center Department of Obstetrics and Gynecology October 23, 2013
Objectives • I have no financial relationships to disclosure • At the end of this lecture you will be able to discuss • The epidemiology of unintended pregnancies in the US and the role for contraception • An overview of contraception that is available and its • Mechanism of Action • Efficacy • Contraindications • Management of Side Effects • The mechanism of Emergency Contraception and its benefits
Epidemiology • Nearly 50% of all pregnancies in the United States are unintended or unplanned • Women younger than 19 years • Significant risk for unintended pregnancy • 80+% of teenaged women describe their pregnancy as unintended • Accounts for 1/5th of all unintended pregnancies • Disproportionately high among women with low educational attainment and low incomes • Race and ethnicity are also associated with unintended pregnancy
Contraception • Definition • Intentional prevention of conception or impregnation through the use of various devices, agents, drugs, sexual practices, or surgical procedures • Obstacles to obtaining contraception • Political • Religious • Social
Hormonal Methods of Contraception • Combined Estrogen-Progestin • Combined Oral Contraceptive Pills (COCs) • Transdermal Patch (Ortho-Evra) • Vaginal Ring (Nuva-Ring) • Progestin-only Methods • Oral Contraceptive Pills • Injectables (Depo Provera) • Subdermal Implants (Nexplanon) • Progestin-containing Intrauterine Device (LNG-IUD, Mirena)
Non-Hormonal Methods of Contraception • Permanent Sterilization • Vasectomy • Tubal Ligation • Tubal Occlusion • Copper IUD (Copper T380-A, Paragard) • Barrier Methods • Condoms • Male and Female • Only contraceptive method that also protects against STIs • Vaginal sponges • Diaphragms • Cervical Caps • Natural Family Planning • Coitus Interruptus (withdrawal) • Very Ineffective • Within one year, 27% of women will become pregnant
Efficacy • Varies greatly by type but also by use • “Perfect use” vs. “Typical use” • Tiers of efficacy • Top-tier • Permanent sterilization • LARC methods • Next tier • Combined hormonal methods • Lowest tier • Barrier methods
Hormonal Contraception • Combined Estrogen-Progestin • Combined Oral Contraceptive Pills (COCs) • Transdermal Patch (Ortho-Evra) • Vaginal Ring (Nuva-Ring) • Progestin-only Methods • Oral Contraceptive Pills • Injectables (Depo Provera) • Subdermal Implants (Nexplanon) • Progestin-containing Intrauterine Device (LNG-IUD, Mirena)
Combined Hormonal Contraceptives Mechanism of Action • Progesterone negative feedback to LH inhibits ovulation • Estrogen negative feedback on FSH inhibits emergence of dominant follicle
Secondary Mechanism of Action • Progesterone • Thins endometrial lining • Thickens cervical mucus • Decreases motility of fallopian tubes
Efficacy: Hormonal Methods • Influenced by patient adherence • Remembering to take a pill, etc. • Combined hormonal methods: Typical failure rate averages 8% at 1 year • Progestin-only pills: 10% failure rate • Injectable: 3% failure rate
Benefits of Combined Hormonal Contraceptives • Alleviates dysmenorrhea • Decreases uterine prostaglandin production • Inhibits ovulation • Cycle control • Improves anemia • Makes menstrual cycles more predictable • Decreases risk of uterine hyperplasia or malignancy in women with anovulatory cycles • Treatment of PMS • Treatment of hirsutism and acne • Increased sex hormone-binding globulin • Suppressed ovarian androgen production
Benefits of Combined Hormonal Contraceptives • Decreases cancer risk • Endometrial cancer is decreased by 50% • Ovarian cancer • Risk is decreased by 27% among ever users of COCs • Longer use is associated with risk reduction up to 50% • Decreased risk for colorectal cancer by 18% • No consensus on recommending this medication for cancer prevention • Improves symptoms that are exacerbated by fluctuations in hormone levels • Sickle cell crisis • Menstrual Migraines
Benefits of Combined Hormonal Contraceptives • Increased bone density • Decreased risk of ectopic pregnancy • Improved endometriosis symptoms • Reduction in benign breast diseases • Prevention of atherogenesis • Decreased incidence and severity of acute salpingitis • Decreased activity of rheumatoid arthritis
Risks of Combined Hormonal Contraceptives • Small increased risk for venous thromboembolism (VTE) • Most risk occurs in the first year of use • Baseline risk for VTE in the population is 4-5/10,000 women years • Pregnancy risk 48-60/10,000 • Combined hormonal contraceptive risk is 12-20/10,000 • Slightly higher in older women or obese women • Dose not increase with history of smoking or hypertension • Risk is eliminated within 30 days of discontinuation
Risks of Progestins • Fourth generation (Drospirenone) has attracted attention for an associated increased risk for VTE when compared to the second-generation progestins • Research suggests that the rate of VTE in drospirenone users remains low (53/100 000) compared with 30.6/100 000 for norgestrel or 27/100 000 for levonorgestrel • SIGNIFICANTLY lower than the risk for VTE among pregnant women
Risk for VTE and Stroke • World Health Organization (WHO) study • Smokers, women older than age 40, and obese women do have a slightly increased risk for an arterial blood clot • Women with uncontrolled HTN have a 10-fold higher than baseline risk for hemorrhagic stroke • Smokers older than age 35 had a 15-20X higher risk for ischemic stroke • Women who have migraines with aura have a slightly higher risk for stroke • Increase is not seen in women younger than 35 years, regardless of smoking or HTN status
Risk for Breast Cancer • Repeated studies • Women using the low-dose COCs (≤ 35 mcg) with no personal history of breast cancer have no increased risk for breast cancer • No additional risk among women with BRCA1 or BRCA2 mutations or a strong family history of breast cancer
Combined Hormonal Contraceptives ABSOLUTE Contraindications • Thrombophlebitis • Thromboembolic disease • Cerebral vascular disease • Coronary Occlusion • Smokers >35 years old • Impaired liver function • Hepatic neoplasm • Congenital hyperlipidemia • Known or suspected breast cancer • Undiagnosed abnormal vaginal bleeding • Known or suspected pregnancy • Migraine with aura
Combined Hormonal Contraceptives Relative Contraindications • Severe vascular headache (classic migraine, cluster) • Severe hypertension • Diabetes mellitus • Gallbladder disease • Obstructive jaundice in pregnancy • Epilepsy • Morbid obesity
Combined Oral Contraceptive Pills (COCs) • Perfect use (0.3%) • Typical use (8%)
Decreased Effectiveness of COCs • Drugs • Barbiturates • Benzodiazepines • Phenytoin • Carbamazepine • Rifampin • Sulfonamides
Side Effects and Management • Breakthrough bleeding (BBT) and spotting • Due to low-dose COCs • Bleeding begins after day 14 of active pills • Early withdrawal bleeding • Increase progesterone component • Bleeding begins during the first 14 days of active pills • Thin / atrophic endometrial lining • Increase estrogen component
Side Effects and Management: BBT continued • Need for increased estrogen • Menses continues into the active pill cycle • Absence of withdrawal bleeding • Causes of increased endometrial activity • More adrenergic progestins • Multiphasic COCs • Different ratios of estrogen to progesterone • Switch to a 28 day cycle instead of an extended cycle
Side Effects and Management • Amenorrhea • Rule out pregnancy • Ensure pills are being taken correctly • Consider increasing the estrogen dose or adding supplemental estrogen • Consider decreasing the progestin dose • Does not have to be addressed if the patient is satisfied • Dysmenorrhea or menorrhagia • Switch to higher progestational and androgenic concentrations • Decrease estrogen component
Side Effects and Management • Breast fullness or tenderness • Occurs in 11% • Perform breast examination • Usually resolves by fourth month of use • Consider possible mammography or ultrasonography if persists • Consider lowering estrogen dose
Side Effects and Management • Nausea • Take with food or at bedtime • Should resolve by the 3rd month • If persists, switch to a preparation with decreased estrogen component and decrease carbohydrates • Symptoms of hypoglycemia then decrease progesterone component
Side Effects and Management • Depression • Consider other alternatives for contraception • Vascular headache or severe migraine • Continuous hormone administration with only occasional withdrawal bleeding • Avoid phasic formulations • May need to consider other method of contraception • Discontinue use if migraines are newly diagnosed after patient begins combined oral contraceptives
Transdermal Contraceptive Patch • Ortho-Evra • Perfect Use 0.3% • Typical Use 8%
Transdermal Contraceptive Patch • Decreased efficacy over 198 lbs (90kgs) • If detached or off for <24 hours then reapply and no backup needed • If detached for >24 hrs then new 4 week cycle should be started immediately and use additional contraception for 7 days • No withdrawal bleed • Pregnancy test • Ultrasound to determine endometrial thickness • >10 mm- endometrial biopsy • Do not add OCPs or progesterone
Risks of Transdermal Patch • Black Box warning • Early 2000s • Increased risk of VTE • Examination of the data suggests that the risk may not be as high as originally believed • Several studies comparing patch to other combined methods did not find a significant difference • May develop irritation at the patch site
Vaginal Ring • NuvaRing • Perfect use 0.3% • Typical use 8%
Vaginal Ring • Lowest steady state hormonal levels of estrogen • Compared to patch and OCPs • Decreased incidence of breakthrough bleeding • Can be removed for up to 3 hours • May decrease vaginal yeast and bacterial infections due to local estrogen effect • May increase leukorrhea • Patients may describe vaginal irritation or discharge
Hormonal Contraception • Combined Estrogen-Progestin • Combined Oral Contraceptive Pills (COCs) • Transdermal Patch (Ortho-Evra) • Vaginal Ring (Nuva-Ring) • Progestin-only Methods • Oral Contraceptive Pills • Injectables (Depo Provera) • Subdermal Implants (Nexplanon) • Progestin-containing Intrauterine Device (LNG-IUD, Mirena)
Side Effects • Progestin-only methods are not associated with increased risks for VTE • Subdermal implant and LNG-IUD are associated with irregular bleeding or intermenstrual spotting • LNG-IUD users will have a range of bleeding patterns from light monthly menses to amenorrhea but irregular spotting will resolve
Depo medroxyprogesterone acetate • Depo-Provera • Perfect Use: 0.3% • Typical Use: 3%
Mechanism of Action: Depo Provera • Prevents pregnancy by inhibiting the secretion of pituitary gonadotropins resulting in anovulation, amenorrhea, and a decreased production of serum estrogen
Side Effects: Depo Provera • Average weight gain of 5.4 pounds • Transient and reversible loss of bone mineral density • No increased risk for fractures • Associated with intermenstrual spotting • Delayed return of fertility • Average return is 10 months
Depo-Provera Indications • Compliance with other methods has been problematic • Breastfeeding • Estrogen-containing preparations are contraindications • Seizure disorders • Sickle cell anemia • Anemia secondary to menorrhagia
Benefits of Depo-Provera • Decreased risk of endometrial carcinoma • Decreased risk of iron-deficiency anemia • Decreased pain • Associated with endometriosis • Associated with endometrial hyperplasia • Associated with dysmenorrhea • Improved compliance • Improved symptoms of menorrhagia • Used for cycle control
Contraindications for Depo-Provera • High risk for osteoporosis • Known or suspected pregnancy • Undiagnosed vaginal bleeding • Known or suspected malignancy of the breast • Active thromboembophlebitis • History of thromboembolic disorders • History of cerebral vascular disease • Liver dysfunction or disease • Known sensitivity to Depo Provera or any of its other ingredients
Bone Health and Depo-Provera • Concern for effect on bone mineral density especially in adolescence • FDA: “use beyond 2 years should be carefully considered and alternative contraceptive methods be evaluated” • Careful use in those women at special risk for osteoporosis • Not considered an indication for dual-energy absorptiometry (DEXA) or other tests that assess bone mineral density
Depo-Provera and Irregular Bleeding: • Education is key • Irregular bleeding • Decreases with each injection • 80% of patients develop amenorrhea • Discontinuation rate of 25% in the first year • Secondary to irregular bleeding • Consider 7 days with conjugated estrogen (1.25mg/day) to assist with irregular bleeding • After discontinuation • 50% resume regular menses within 6 months • 25% do not resume menses for more than 1 year • Should be evaluated to detect other possible causes
Progestin-Only Pills • Mini-pill • Norethindrone .35 • Perfect Use: 0.5% • Typical Use: 8%
Progestin-Only Pills • Thickens cervical mucous and inhibits ovulation • No hormone free interval • Take in a continuous fashion • MUST take at the same time each day • More than 3 hours of delay should be considered a missed pill and back up method should be used • More variable bleeding patterns • Can be used in breastfeeding women without decrease in breast milk • Decreases menorrhagia and associated anemia and cramps • Offers some protection against endometrial cancer • May reduce the risk of PID secondary to cervical mucous thickening
Long Acting Reversible Contraception (LARC) Methods • Levonorgesterel IUD (LNG-IUD) • Inserted in to the uterus • FDA approved for five years • Prevents pregnancy by thinning the endometrial lining of the uterus, thickening cervical mucus and slowing tubal motility, which prevent sperm passage • Subdermal Implants • Placed in the arm between the bicep and triceps muscles • Lasts for 3 years • Suppresses ovulation • Nonhormonal Copper IUD (Copper T380-A) • Inserted into the uterus • Lasts for 10 years • Creates a sterile inflammatory state rendering the uterus inhospitable to sperm or ova
ACOG Committee Opinion: LARC • “High unintended pregnancy rates in the United States may in part be the result of relatively low use of long-acting reversible contraceptive (LARC) methods, specifically the contraceptive implant and intrauterine devices.” • “Because of these advantages and the potential to reduce unintended pregnancy rates, LARC methods should be offered as first-line contraceptive methods and encouraged as options for most women. To increase use of LARC methods, barriers such as lack of health care provider knowledge or skills, low patient awareness, and high upfront costs must be addressed.”
LARC Use • LARC methods have few contraindications • Almost all women are eligible for implants and intrauterine devices • Because of these advantages and the potential to reduce unintended pregnancy rates, LARC methods should be offered as first-line contraceptive methods and encouraged as options for most women • Less than 5% of women in the USA have ever used a LARC device