Update on Contraception 2014 Catherine Waits, MSN, APRN KCNPNM Conference April 2014 OBJECTIVES: 1. Recognize that unintended pregnancy is a primary health concern 2. List varieties of contraceptive methods. 3. Identify risks, benefits and side effects of the various contraceptive methods. 4. Identify contraceptive methods that are safe to use with certain medical conditions. 5. Review principals of emergency contraception Why do we care? “No woman is completely free unless she is wholly capable of controlling her fertility and… no baby receives its full birthright unless it is born gleefully wanted by its parents.” – Alan F. Guttmacher 1898-1974 Percentage of Women Experiencing Unintended Pregnancy in First Year of Using Contraceptive * Standard Days Method: 5%, Two Day Method: 4% Hatcher RA. Contraceptive Tech. 19th ed. 2007. • • • • FP-1 Increase the proportion of pregnancies that are intended Intended pregnancy (females 15–44 years) 2002 Baseline: 51.0% 2020 Target: 56.0% http://healthypeople.gov/2020/topicsobjectives2020/objectivelist.aspx?topicid=13 Graph: Center on Children and Families at Brookings Report, Policy for Preventing Unplanned Pregnancy March 2012 Counseling Considerations • Future pregnancy plans ▫ “When do you plan to get pregnant?” • Patient’s health history ▫ ▫ Consider special needs U.S. Medical Eligibility Criteria for Contraceptive Use 2010 (US MEC) http://www.cdc.gov • Efficacy of contraceptive ▫ Review the typical failure rate of the methods • Patient Preference ▫ ▫ Reduce barriers to contraception U.S. Selected Practice Recommendations for Contraceptive Use (US SPR) http://www.cdc.gov Menstrual Cycle The Menstrual Cycle Chart copied from http.//gettingpregnant.com/menstrual-cycle Hatcher RA & Namnoum AB (2004) Contraceptive Hormonal Effects ESTROGEN PROGESTIN • ↓ follicle-stimulating hormone release • ↓ luteinizing hormone secretion • Suppresses LH surge • Blocks ovulation • Blocks ovulation • Thickens cervical mucus • Endometrial effects • Slows tubal motility • ↑ HDL cholesterol • Induces endometrial atrophy • ↓ LDL cholesterol • ↑ LDL • Triglycerides levels are slightly ↑ • ↑ liver production of serum globulins involved in coagulation • ↓ HDL & Triglycerides • No effect on coagulation factors Contraceptive Mechanism of Action Suppress ovulation Reduce sperm transport in upper genital tract (fallopian tubes) Change endometrium making implantation less likely Thicken cervical mucus (preventing sperm penetration) Hatcher & Namnoum (2004 Contraceptive Options: Hormonal Contraceptives Barrier Methods Natural CONTRACEPTIVE OPTIONS: HORMONAL NON-HORMONAL • ORAL CONTRACEPTIVES • • • • • • • • VAGINAL RING • TRANSDERMAL • IMPLANT • INTRAUTERINE • INJECTION • • • • CONDOMS (male and female) DIAPHRAM CERVICAL CAP SPONGE FOAM NATURAL FAMILY PLANNING CERVICAL MUCUS OVULATION DETECTION METHOD LACTATIONAL AMENORRHEA METHOD WITHDRAWAL INTRAUTERINE COPPER IUD STERILIZATION Combined Hormonal Contraceptive Methods “CHC” 4 mm 54 mm • Ethinyl Estradiol + one of 7 different Progestins • Efficacy Rate: • Perfect Use=0.1 pregnancies / 100 women • Typical Use=3 pregnancies / 100 women • “Low Dose” is 35 mcg or less • Monophasic or Multiphasic Pills • Extended Dose 24 day/ 91 day • Vaginal Ring (NuvaRing) • Transdermal Patch (Ortho-Evra) • Convenient, easy to use, user control • Does not interfere with intercourse Dickey RP (2010) Zieman M (2010-2012 Combined Hormonal Contraceptives Benefits Improvement of cycle-related conditions: • Acne • Irregular menstrual cycles • Dysmenorrhea • Menorrhagia • Anemia • Functional ovarian cysts Reduction in cancer of certain organs: • Ovary • Endometrium • Colon and rectum Side Effects Early side effects • Nausea • Breast tenderness • Headache • Oily skin (acne may worsen or improve) Mood changes Weight gain Breakthrough bleeding Other side effects • Thromboembolic effects (rare) CONTRAINDICATIONS: COMBINED HORMONAL CONTRACEPTIVES THROMBOEMBOLIC DISORDERS Deep Vein Thrombosis; Pulmonary Embolism Blood Clotting Disorders i.e. Factor V Leiden Family History of thrombophilias CARDIOVASCULAR DISEASE MIGRAINE WITH AURA UNCONTROLLED HYPERTENSION >140/90 MAJOR SURGERY WITH PROLONGED IMMOBOLIZATION CIGARETTE SMOKING IN WOMEN GREATER THAN 35 YEARS BREAST CANCER: CURRENT OR PAST ) Reproductive Health Access Project (2012 Combined Hormonal Contraceptive Key Points • CHC contain ESTRIDIOL and one of seven available PROGESTINS ▫ Low Dose Estrogen is safe, effective, convenient, rapidly reversible • Extended-cycle regimens decrease menstrual bleeding and symptoms associated with the traditional hormone-free interval • CHC benefits: ▫ ▫ ▫ ▫ ▫ Cycle control: less bleeding, less cramping, suppression of endometriosis Fewer ovarian cysts Decreased fibrocystic breast changes Favorable impact on lipids: increased HDL and reduces LDL Decreased risk of ovarian and endometrial cancers OCP FORMULATIONS Progestins in Combination Contraceptives 1st Generation • Norethindrone (Junel 1/20) • Medroxyprogesterone acetate (Depo Provera) 2nd Generation • Levonorgestrel (Lo Seasonique) • Norgestrel (Cryselle) 3rd Generation • Desogestrel (Apri, Desogen) • Etonogesterol (Nuva ring, Nexplanon) 4th Generation • Drospirenone (Yaz) • Dienogest (Natazia) • Nomegestrol Acetate (Patch) Davtyan (2012) Oral Contraceptive Products Name Ethinyl Estradiol Progestin Characteristics LoSeasonique Loestrin 1/20 20 mcg 20 mcg Levonorgestrel 0.1 mg Norethindrone acetate 1 mg Regular or light menses 2-4 d Mircette Ortho Tricyclen Lo 20 mcg 25 mcg Desogestrel 0.15 mg Norgestimate Regular or mod. menses 4-6 d Mild or no cramps Moderate cramps 0.180/ 0.215/0.250 Ovral (Norinyl 1/35) 50 mcg 35 mcg Norgestrel 0.5 mg Norethindrone 1.0 mg Regular Heavy menses 6+ d Alesse Yaz 20 mg 20 mg Levonorgestrel 0.1 mg Drospirenone 3.0 mg Irregular menses. Acne, oily skin, hirsutism LoSeasonique Ortho-Micronor 20 mcg ----0--- Levonorgestrel 0.1 mg Norethindrone 0.35 mg H/O excessive nausea & edema during pregnancy Alesse Ortho Tricyclen Lo 20 mcg 25 mcg Levonorgestrel 0.1 mg Norgestimate H/O excessive pregnancy 0.180/ 0.215/0.250 Severe cramps H/O fibroids; fibrocystic breasts weight gain & varicose veins Depression; Premenstrual edema Ortho Tricyclen Lo Ortho Novum 777 25 mcg 35 mcg Norgestimate Norethindrone Weight less than 110 pounds Ovral (Ortho Novum 777) 50 mcg 35 mg Norgestrel 0.5 mg Weight more than 160 # Dickey RP (2010) pg125-144 Transdermal Contraceptive Patch Transdermal Contraceptive Patch: Application Size: 4.5 cm square patch Ethinol Estridiol 20 mcg plus Norelgestromin 150 mcg Efficacy may be diminished with women over 198# Apply weekly for 3 weeks then 1 week off for withdrawal bleeding Apply to buttocks upper outer arm lower abdomen upper torso (excluding the breast) Transdermal Contraceptive Patch Advantages Weekly application encourages compliance Easy verification of presence reassures user of continued protection Does not require vaginal insertion Contraceptive effects are rapidly reversible Excellent cycle control after 3 months Disadvantages Application site reactions Not as effective in women weighing >198 pounds Side effects are similar to oral contraceptives except for: Higher rates of breast pain during first 2 months Higher rates of dysmenorrhea May be difficult to conceal No protection against HIV or other sexually transmitted infections Vaginal Contraceptive Ring Vaginal Contraceptive Ring: • Provides continuous delivery of: Ethinyl estradiol 15 mcg — lower dose of estrogen than used in OCP’s Etonogestrel 120 mcg—the active metabolite of desogestrel • • • • The vaginal ring is flexible, easy to insert and remove. The ring is worn for three weeks then discarded. A new ring is inserted one week later for a 28- day cycle. Initiate with “quick start” if reasonably certain pt is not pregnant Vaginal Contraceptive Ring: Insertion There is no wrong way to insert the ring. If it lies comfortably in the vagina, it has been placed correctly. Vaginal Ring Advantages Disadvantages Self-administered Shorter, lighter periods Patient does not have to take daily Some breast tenderness Low dose estrogen Weight neutral Less side estrogenic side effects generally no nausea, or breast tenderness Increase in vaginal discharge Headache Does not affect lipoproteins Vaginitis Effective for all body types Must digitally self insert Steady-state hormone levels Drug Interactions • Interactions between CHC and other medications may occur. • Interactions resulting in reduced contraceptive efficacy are of most concern. • Spotting or breakthrough bleeding may occur. • Advise to use back-up method if using antibiotic Side Effect Management • Break Through Bleeding ▫ Any woman beginning a new form of hormonal contraception For adolescents, breakthrough bleeding may discourage continued use • Women who inconsistently use oral contraceptives or miss doses • Skipping even one pill can result in BTB • CHC users who have chlamydial cervicitis and/or endometritis • Consider infection if BTB occurs after several cycle uses ▫ Smokers have a 30% increase in BTB due to anti-estrogenic effects Burkman RT (2007) Lohr PA & Creinin MD (2007) Barr NG (2010) Side Effect Management • Nausea ▫ Take pill at bedtime, or at a meal ▫ Use low estrogenic activity pill • Fluid Retention ▫ Change to low estrogenic activity pill • Increased Appetite/Weight Gain ▫ Change to Low Estrogen Activity and Low Androgenic Activity Pill ▫ Low Estrogenic Pills: Any 20 mcg EE pill ▫ Low Progestin Pills: Alesse, TriNorinyl, OrthoTriCyclen Lo • Menstrual Migraine Headaches ▫ Change to OCP with Low Estrogenic Activity ▫ Progesterone Only OCP ▫ Continuous cycle • Major Depression ▫ Use OCP with Low Progestin Activity ▫ Low Adrogenic Pills: Orthotricyclen Lo Ortho Cyclen Mircette, Natazia, Yaz Dickey 2010 (14th Ed) Oral Contraceptives and the Risk of Cardiovascular Event: Stroke, MI, VTE • Helping Your Patients Decide: Making Informed Health Choices About Hormonal Contraception (June 2006) Association of Reproductive Health Professionals –ARHP@arhp.org Side Effect Management • Hypertension ▫ If previous HTN during pregnancy, use with caution and monitor ▫ B/P relatively well-controlled==use CHC with caution ▫ Consider Progestin-Only or Non-Hormonal Method Reproductive Health Access Project (2013) Oral Contraceptives and the Risk of Breast Cancer • “Our analyses suggest that associations between ever use of OCs and ovarian and breast cancer among women who are BRCA1 or BRCA2 mutation carriers are similar to those reported for the general population” Moorman PG, et al. (2013) • “No significant increase in breast cancer risk associated with COC use has been found in case-control studies in BRCA1 (OR: 1:08; p=0.250), in BRCA2 (OR: 0.80; p=0.147).” Cibula D, Sikan M, Dusek L, Majek O. (2011). • “In a majority of studies there is no increase in the risk of breast cancer reported in OC users.” Cibula D, et al. (2010) • “In our study oral contraception was not associated with a significantly increased risk of any cancer.” Hannaford, PC et al (2007) Progestin-Only Contraceptives Progestin Effects of Contraceptive Hormones • Decreases luteinizing hormone secretion • Blocks ovulation • Thickens cervical mucus • Slows tubal motility • Induces endometrial atrophy • Increases LDL • Decreases HDL & Triglycerides • No effect on coagulation factors Candidates for Progestin-Only Contraceptives • Women with contraindications for combination hormonal contraceptives, including a history of: ▫ ▫ ▫ ▫ Venous thrombosis Vascular disease Hypertension Heavy smoking (>35 years) • Lactating women Progestin-Only Oral Contraceptives • “Mini-Pill” or “POP” • Two formulations: Norethindrone & Norgestrel • Efficacy Rate: ▫ ▫ • Perfect Use= 0.5 pregnancies / 100 women Typical Use= 3 pregnancies / 100 women Consistently timed ingestion is required ▫ Plasma levels fall to baseline after 24 hours ▫ If ingestion occurs more than 3 hours after a required dose, back-up contraception should be used for 48 hours Dickey RP (2010) Zieman M, et al. (2010-2012) Progestin Only Methods Advantages Estrogen-free Safe in breast-feeding Can be used in sickle-cell disease, HTN, Lupus, stroke, migraine, smokers >35 years Self-administered for POP Long Acting Reversible Contraception (Injection, Implant and Intrauterine) NO change in ovulation and menses after stopping Implant or IUS Disadvantages Oral must be taken every day at the same time Every pill is an active pill, Irregular bleeding (70% in first year) Increased risk of developing ovarian cysts Increased risk of developing DM with past history of Gestational DM Delay in ovulation and menses after stopping injections Decreases HDL cholesterol Weight gain Depression Drug interactions: Dilantin, Tegretol Carbatrol, Rifampicin, St. John’s Wort Progestin-Only Injection Depo Provera Medroxyprogesterone 150 mg IM every 11-13 weeks Efficacy Rate: Perfect Use=0.3 pregnancies / 100 women Typical Use=<1 pregnancies / 100 women Mechanism: Thickens cervical mucus Blocks the LH/FSH surge Slows tubal motility Thins endometrial lining Initiate method: First week of menses or Quick Start if reasonably certain not pregnant Dickey RP (2010) Zieman M et.al. (2010-20120 Contraceptive Injection Advantages Disadvantages Decreased menstrual bleeding/ cramping • Irregular bleeding Improvement with endometriosis • Amenorrhea Reduces risk of endometrial cancer • Hypoestrogenism Reduces risk of ovarian cancer ▫ Vaginal dryness Safe to use with blood clotting disorders ▫ Acne Good with seizure disorder ▫ Hirsutism Effective for physically challenged • Return to fertility may be delayed Decreases ectopic pregnancies • No protection from STI Breast feeding is not compromised • Weight gain ▫ Private • Average of 5.4# in first year Bone mineral density effect ▫ ▫ ▫ Calcium either diet or supplement Weight bearing exercise Avoid Cigarette use Zieman M, et al (2010) Depo-Provera (medroxyprogesterone acetate injectable suspension • Audience: Reproductive and other healthcare professionals • FDA and Pfizer notified healthcare professionals of the addition of a • BOXED WARNING along with revisions to the WARNINGS, INDICATIONS AND USAGE, PRECAUTIONS and POSTMARKETING EXPERIENCE sections of the prescribing information to include information on the loss of significant bone mineral density. • Depo-Provera Contraceptive Injection is indicated only for the prevention of pregnancy in women of child-bearing potential. Bone loss is greater with increasing duration of use and may not be completely reversible. Depo-Provera Contraceptive should be used as a long-term birth control method (eg, longer than 2 years) only if other birth control methods are inadequate. [November 18, 2004 - Dear Healthcare Professional Letter1 - Pfizer] [November 18, 2004 - Dear Healthcare Organization Leader Letter2 - Pfizer] [November, 2004 - Label3 - Pfizer] ACOG Committee Opinion Number 415, September 2008 Committee on Adolescent Health Care Committee on Gynecologic Practice “Conclusion • Depot medroxyprogesterone acetate is a safe and effective means of long-term contraception, which has likely contributed to a decrease in adolescent pregnancy rates over the past decade. Concerns regarding the effect of DMPA on BMD should neither prevent practitioners from prescribing DMPA nor limit its use to 2 consecutive years. Appropriate counseling with a discussion of current medical evidence should occur before the initiation of this medication and during prolonged use. Practitioners should not perform BMD monitoring solely in response to DMPA use because any observed short-term loss in BMD associated with DMPA use may be recovered and is unlikely to place a woman at risk of fracture during use or in later years. Effective long-term contraceptive methods that have no effect on BMD and have high continuation rates, such as contraceptive implants and intrauterine devices, should also be considered as first-line methods for adolescents.” Key Points: Injection • First of the Long Acting Reversible Contraceptives • Irregular bleeding is common side effect –counsel patients to expect • Safe immediately postpartum • Bone density reverts to normal after discontinuation of use ▫ May safely use for longer than 2 years ▫ Unnecessary to give supplemental estrogen ▫ Bone Density Testing is not recommended • Weight gain is a common side effect ▫ Encourage daily exercise, calcium and vitamin D intake Contraceptive Implant NEXPLANON™ • Single-rod implant (4 cm in length and 2 mm in diameter) made of ethylene vinyl acetate and contains 68 mg of etonogestrel ▫ Initially progestin is released at rate of 60 mcg per day ▫ Decreases to 25-30 mcg/ day by end of first year Efficacy Rate: ▫ Perfect Use=0.3 pregnancies/ 100 women ▫ Typical Use=0.3 pregnancies / 100 women • Mechanism of Action: ▫ Thickens cervical mucus ▫ Inhibits ovulation ▫ Atrophy of endometrium Initiation of method: Withinn 7 days of last menstrual period; no back up method needed May insert anytime in the cycle, use backup for 7 days MUST BE A CERTIFIED PROVIDER TO INTALL DEVISE “Clinical Training Program for NEXPLANON” ideveloped by Merck Dickey RP (2010) Zieman M et.al. (2010-20120 Contraceptive Implant Advantages Active for three years Estrogen-free Safe in breast-feeding Can be used in sickle-cell disease and seizure disorder Patient does not have to take daily Can be removed at any time Rapid return of fertility Inconspicuous Serum levels of etonogestrel are detectable within hours of insertion Disadvantages Irregular bleeding No periods at all Requires clinician visit for insertion and removal Does not protect against sexually transmitted infections Key Points: Implant • Easy and quick to insert and remove • Efficacy equivalent to sterilization • Safe and rapidly reversible • Irregular bleeding patterns may be a problem for some patients • Majority of reproductive-age women are candidates, including adolescents • Appropriate option for those preferring a long-term progestin-only method and do not want injections or an intrauterine device Summary • Progestin-only-contraceptives are safe and effective methods of contraception ▫ Long –Acting-Reversible Contraception (LARC) ▫ Orals require consistently timed ingestion of dose for maximum efficacy ▫ Most common side effects are bleeding irregularities and weight gain ▫ Very few contraindications for use—almost always a MEC 1 or 2 • Progestin-only emergency contraception (Plan B One Step) is approved for over-the-counter sales to women over 15 years of age Intrauterine Contraceptives Mirena® • Levonorgestrel 20 mcg releases every 24 hrs System (LNG-IUS) Levonorgestrel-Releasing Intrauterine • Efficacy Rate: ▫ Perfect Use=0.3 pregnancies/ 100 women ▫ Typical Use=0.3 pregnancies/ 100 women • Mechanism of Action: ▫ Thickens cervical mucus • Indicated for dysmenorrhea and heavy bleeding ▫ Tubal fluid changes impair sperm & ovum migration • Endometrial protection during hormone or tamoxifen therapy ▫ Suppresses endometrium ▫ Inhibits ovulation • Long-Acting Reversible Contraception • Initiate method: ▫ ▫ Insert within 7 days of LMP; no backup needed Insert anytime in cycle and use backup method for 7 days • Duration of use: 5 years ParaGard® T380A Copper-Releasing Intrauterine Contraceptive • Polyethylene device with 380 mm3 of exposed copper • Efficacy Rate: • • Perfect Use=0.8 pregnancies per 100 women • Typical Use=3 pregnancies per 100 women Mechanism of Action: ▫ Spermicide Copper ions inhibit motility and viability of sperm Inflammatory reaction of endometrium ▫ Inhibition of implantation is a secondary mechanism • Initiate Method: ▫ Anytime in cycle; NO backup needed ▫ May remove & insert in same visit ▫ STI screening on day or insertion is acceptable • Duration of use: 10 years • Indicated for emergency contraception Intrauterine Contraception Counseling Topics • • • • • Effectiveness of intrauterine contraception Mechanism of action No protection against HIV or other sexually transmitted infections Noncontraceptive benefits Side effects ▫ At insertion—variable pain, cramping, vasovagal reaction ▫ First few days—light bleeding, mild cramping ▫ First few months—intermenstrual bleeding, cramping Copper IUD: Heavier or prolonged menses LNG-IUS: Gradual decrease in menstrual flow • Instructions on how to check the IUD string • Return for follow-up appointment 4-6 weeks after placement Intrauterine Contraception Advantages • Highly effective birth control • Long lasting • No daily, weekly, monthly responsibility • With Mirena, bleeding changes • Weight neutral • Cost effective • May be used with nulliparous Disadvantages • • • • Painful to insert Possibility of perforation Possibility of expulsion Professional assistance to insert and remove • Amenorrhea or Dysmenorrhea • Ovarian cysts • No protection against STI Male and Female Barrier Contraceptives Efficacy of Contraceptives Barrier Contraceptives Efficacy Male Condom 82% effective with typical use Female Condom During first year of use, 21% of women experience an unintended pregnancy Diaphram In 28-week multicenter randomized, parallel group study of unadjusted typical use, probability of pregnancy is 7.9% Spermicide • Six- month probability of an unintended pregnancy is 10-22%, depending on dose and formulation • Use of spermicidal in combination with another barrier method improves efficacy to using either alone Sponge 12- mo. cumulative life table pregnancy rate = 17.4% Parity affects failure rate: •Nulliparous: 9% to 10% •Parous: 19%- 21% Male Condom Latex condom Advantages Highly effective against most STI’s More resistant to breakage than polyurethane condoms Disadvantages Cannot be used if have latex allergy Do not use with oil-based lubricants Degraded by heat, light, and oxidation Polyurethane condom Advantages Safe to use with latex allergy Thinner material than latex Odorless/colorless May sensation of body heat during intercourse Can be used with all lubricants Disadvantages Not as effective in protecting against STI’s as the latex condom Expensive Female Condom Advantages Disadvantages Some protection against STI’s No Rx required Can be inserted up to 8 hrs before intercourse* should be removed shortly after Made of polyurethane o o o o o o May not be as effective against pregnancy as the male condom Must be inserted and removed by woman Available in only one size Single use only May be noisy Outer ring may be visually unappealing and uncomfortable *Division of Reproductive Health, National Center for Chronic Disease and Prevention and Health Promotion, 2013 Sponge Advantages Made of latex-free material (polyurethane) One size fits all Does not require a prescription Preloaded with nonoxynol-9 spermicide Can be inserted up to 24 hours before intercourse Can be left in place for up to 30 hours Disadvantages Vaginal insertion and removal Should remain in place for six hours after last intercourse May increase risk of urinary tract infections and toxic shock syndrome Not recommended for use more than once per day Reduced efficacy among parous women Effective Spermicide Advantages No prescription required Disadvantages Some spermicides must be applied 10 to 15 minutes before initiation of intercourse Must be reapplied every 1 to 2 hours Do not protect against sexually transmitted infections Increases risk for urinary tract infections May cause irritation May be messy or leak Increased lubrication during intercourse VCF Film convenient and discreet • • Available as creams, gels, film, foam, and suppositories containing nonoxynol-9 Used alone or with a barrier method Diaphragm Advantages • Can be inserted hours before intercourse • Does not require removal between acts of intercourse Disadvantages • Some are made of rubber, a potential allergen • Must be prescribed and fitted by a clinician • Requires vaginal insertion and removal • Spermicide must be reapplied before each act of intercourse • Must be worn for at least 6 hours after last intercourse, but not more than 24 hours • May increase risk of urinary tract infections and toxic shock syndrome • Low Cost Used with a spermicide Key Points: Barrier Methods • A number of prescription-only and over-the-counter barrier methods are available • Some methods provide protection against sexually-transmitted infections • Barrier methods are less effective than hormonal methods • Devices must be placed before coitus, reducing spontaneity • May require cooperation of partner • Nonoxynol-9 does not prevent sexually transmitted infections but does kill sperm Natural Contraceptive Methods Efficacy of Contraceptives Natural Contraceptives Efficacy Abstinence Perfect Use: 1-9/ 100; Typical Use= 20 pregnancies/ 100 women Breastfeeding/ LAM Perfect use: 2/100 Typical use: 5/100 women will get pregnant Effectiveness rates only apply to women who are exclusively breastfeeding for the first 6 months postpartum. (Lactational Amenorrhea Method) Fertility Awareness Perfect Use = 1-9/ 100 Typical Use=12-25/100 women Best if combine Basal Body Temperature/ Calendar/ Cervical Mucus Methods Coitus Interruptus “Withdrawal” Perfect Use=4/100; Typical Use=27/pregnancies / 100 women ZiemznM, et al (2010) Samra-Laff OM & Wood E (2009) Stacy,D (2012) Lactational Amenorrhea Method (LAM) Mechanisms of Action Frequent intense suckling disrupts secretion of gonadotrophin releasing hormone (GnRH) Irregular secretion of GnRH interferes with release of follicle stimulating hormone (FSH) and luteinizing hormone (LH) Decreased FSH and LH disrupts follicular development in the ovary to suppress ovulation LAM: Benefits vs. Limitations Benefits Limitations • Effective (1-2 pregnancies per 100 women during first 6 months of use) • • Effective immediately User-dependent (requires following instructions regarding breastfeeding practices) • Does not interfere with sexual intercourse • May be difficult to practice due to social circumstances • No systemic side effects • • No medical supervision necessary Highly effective only until menses return or up to 6 months • No supplies required • • No cost involved Does not protect against STDs (e.g., HBV, HIV/AIDS) Methods of Fertility Awareness/NFP • • • • Calendar/Standard Days Basal Body Temperature (BBT) Cervical Mucus (Billings) Symptothermal (BBT + cervical mucus) Natural Family Planning (NFP) Mechanism of Action Conditions Requiring Precaution For contraception: • Irregular menses • Persistent vaginal discharge • Breastfeeding ▫ Avoid intercourse during the fertile phase of the menstrual cycle when conception is most likely. For conception: ▫ Plan intercourse near mid-cycle (usually days 10-15) when conception is most likely. Natural Family Planning (NFP Benefits Limitations • • Requires daily record keeping • Vaginal infections make cervical mucus difficult to interpret • Basal thermometer needed for some methods • Does not protect against STDs (e.g., HBV, HIV/AIDS) Can be used to prevent or achieve pregnancy • No method-related health risks • No systemic side effects • Inexpensive Withdrawal A traditional method of family planning in which the man completely removes his penis from the woman’s vagina before he ejaculates Sperm do not enter the vagina and fertilization is prevented Benefits • Effective immediately • Does not affect breastfeeding • Can be used as backup to other methods Limitations • Effectiveness depends on willingness of couple to use method with every act of intercourse • Always available • Effectiveness may be further decreased by sperm from a recent (< 24 hours) ejaculation remaining in the penis (urethra) • No cost involved • May diminish sexual pleasure • No method-related health risks • Does not protect against STDs (e.g., HBV, HIV/AIDS) Abstinence • Mechanism ▫ excludes sperm from female reproductive tract • Effectiveness ▫ 0% failure rate • Complications ▫ recent data have shown an increase in teen sexual activity and pregnancy if no education is given on contraception Ideal for adolescents at high risk for pregnancy and STD’s including HIV Sterilization Methods Female Sterilization: Mechanism of Action By blocking the fallopian tubes (tying and cutting, rings, clips or electrocautery), sperm are prevented from reaching ova and causing fertilization. Non-Surgical Tubal Occlusion Brand name: Essure® • Tubal sterilization through hysteroscopic placement of micro-coil in fallopian tubes Sterilization Advantages • Ideal for those desiring no more children • Quick recovery Disadvantages • Permanence ▫ Reversal is expensive, requires major surgery, and is not guaranteed • Lack of significant long-term effects • Regret for the decision • Cost-effective • Expense at time of procedure • No need to remember to use contraception before intercourse • Procedure requires aseptic conditions, surgical equipment, trained clinicians, and anesthesia • No need for partner compliance • High degree of safety; low mortality rates • Does not protect against HIV or other sexually transmitted infections Male Sterilization: Vasectomy • Mechanism of Action: ▫ Blocks vas deferens (ejaculatory duct) ▫ Sperm are not present in the ejaculate • Types ▫ No-scalpel technique (preferred) ▫ Incisional Sterilization: Counseling Guidelines • Discuss other contraceptive options, that in addition to sterilization, provide effective long-term protection from pregnancy ▫ ▫ ▫ ▫ ▫ Side effects, risks Suitability for the patient Failure rates, stressing that no contraceptive method is 100% effective Recovery Permanence and potential for reversibility • Allow sufficient time between patient counseling, decision making, and the sterilization procedure to ensure a thoughtful and informed decision (especially for patients considering a postpartum or postabortion sterilization) 30 days is required by law for patients with Federally subsided insurance. Sterilization: Legal and Ethical Issues • Informed consent • Spousal/partner consent is not required • For federally funded sterilizations, the patient must: ▫ be at least 21 years of age ▫ be mentally competent ▫ wait 30 days after signing an informed consent form before undergoing the sterilization procedure What If…? …the condom broke or slipped off... …you forgot your regular birth control... …you were forced to have sex... Emergency Contraception Levonorgestrel products inhibit ovulation Ulipristal inhibits follicular rupture Paragard used as EC inhibits implantation Best if used within 72 hours of unprotected intercourse Plan B- One Step (Levonorgestrel 1.5 mg) ▫ One time dose ▫ Over-the-Counter Ella (Ulipristal Acetate 30 mg) ▫ One time dose ▫ Prescription only Paragard (Cu T380) ▫ Inserted up to 5 days after unprotected intercourse ▫ Is most effective EC but least used ▫ Trussell J; Raymond EG; Cleland K (2014) Choosing Contraceptives Patient Needs & Concerns: • “How important is it to avoid pregnancy right now?” • “Do you want your use of contraception to be private?” • “Do you have concerns about a particular contraceptive?” • “What side effects are you willing to accept?” • “What methods have you used in the past?” • “Do you have new health issues?” Hormonal Contraceptives: Coexisting Medical Conditions CDC United States Medical Eligibility Criteria for Contraceptive Use (US MEC) • MEC 1: Can use. No restriction. • MEC 2: Can use with closer medical supervision • MEC 3: Should not use. Method of last choice with regular monitoring. • MEC 4: Should not use. Unacceptable health risk. US MEC with Certain Medical Conditions TCu-380A POC CHC Medical Conditions Hypertension (controlled=140/90) 1 3 2 History of DVT or pulmonary embolism 1 4 2 Varicose veins 1 2 1 Stroke 1 4 2 Severe valvular heart disease (complicated) 2 4 2 HIV infection 2 1 1 2 Check drug interactions 2 Headaches-migraine with aura 1 4 2 Postpartum not breast feeding < 21 days 1 3/4 2 Smoker > 35 y/o 1 4 1 AIDS (clinically well on antiretroviral therapy) US Medical Eligibility Criteria for Contraceptive Use. 2010 Cardiovascular Disease: Conditions that increase risk of CVD • Diabetes • HTN • Thrombophilias • Obesity • Migraine headaches • Immbolization • Valvular Disease Diabetes Are combination hormonal contraceptives (CHC) safe for women with diabetes? YES • CHCs do not significantly affect glycemic control • CHCs do not accelerate diabetic vascular disease • CHCs do not precipitate the risk of developing DM DO NOT LIMIT USE OF CHC Non-SMOKERS Otherwise healthy: ø ø ø ø HTN nephropathy neuropathy vascular disease Headache What kind of HEADACHE is it? Migraine w/ Aura • Visual disturbance in both eyes • Unilateral numbness • Flashing or moving scotoma • "Pins & needles" in extremities • Unilateral weakness • Aphasia or other speech difficulties Migraine • Nausea/ Vomiting • Photophobia • Watery Eyes • Taste or smell sensations What to prescribe with Headaches? Condition COC + Patch & Ring Depo-Provera Mirena Implanon Progestin-only pills Non-migraine headaches 1/2 1 1 Migraine w/o aura, age <35 2/3 2 1/2 Migraine w/o aura, age >35 3/4 2 1/2 Migraine with aura, any age 4 2/3 2/3 U.S Medical Eligibility Criteria for Contraception. 2010 Postpartum and Breastfeeding CHC Progestin Implant DMPA Cu-IUD LNGIUS 4 3 3 * * 3 1 1 1 1 Postpartum < 21 days 3 1 1 3 3 3-4 wks 1 1 1 3 3 1 1 1 1 1 Breastfeeding < 6 weeks PP 6 weeks to 6 months PP > 4 wks * See below. Seizure Disorders Interactions Between Anticonvulsants and Combination Contraceptives •Anticonvulsants that decrease serum steroid levels ▫Barbiturates (including Phenobarbital and primidone [Mysoline] ▫Carbamazepine (Tegretol) and oxcarbazepine (Trileptal) ▫Felbamate (Felbatol) ▫Phenytoin (Dilantin) ▫Topiramate (Topamax Anticonvulsants that do not decrease serum steroid levels •Gabapentin (Neurontin) •Lamotrigine (Lamictal) •Levetiracetam (Keppra) •Tiagabine (Gabitril) •Valproic acid (Depakene) •Zonisamide (Zonegran) Improving Contraceptive Compliance Contraceptive Counseling • Start visit with discussion of future fertility plans ▫ What are your childbearing plans? • Discuss the patient’s preferences ▫ What has worked for you before? ▫ What is your partner’s preference? • Consider patient’s medical history ▫ Choose contraceptive for both safety and efficacy Quick Start Method Patient Follow-up • Schedule a recheck visit • Ask: Are you satisfied with your contraceptive method? Is there anything you would change? Are you having bleeding problems or other side effects? Missed Pills (combined OCs) Action Advised Take Missed dose ASAP Take “make-up” dose Use backup contraception Begin next cycle <12 hrs (late for dose) 12-24 hrs (missed 1 pill) >24 hrs (missed 2 pills) >48 hrs (>2 pills missed) Yes Yes Yes NA1,2 Yes1,2 Yes1 No2 No No1,2 No1 Yes – 7 days2 Yes – 7 days1,2 Yes – 7 days1,2 No change No change No change In wk 3 -begin day 22 Yes 1,2 “A-C-H-E-S” • Abdominal pain (severe) • Chest pain (severe, cough, SOB, sharp pain on inhaling • Headache (severe) or if accompanied by dizziness, weakness, or numbness, especially if one-sided • Eye problems (vision loss or blurring) or speech problems • Severe leg pain (in calf or thigh) Drug Interactions and OC Mechanism Action Recommended Antibiotics (broad spectrum) penicillins, teracyclines. Griseofulvin Alteration of the steroid gut metabolism due to changes in the intestinal flora Use of an alternative or backup method during antibiotic therapy is recommended. Acitretin (soratane) Mechanism unknown. Reduces the efficacy of progestin only pills. Unknown if interaction is seen with COC. Use alternative or additional form of contraception. Agent Drug Interactions and OC (cont) Agent Mechanism Action Recommended Anticonvulsants (phenytion, carbamazepine, phenobarbital, primidone) Cytochrome P450 interaction (CYP3A4 induction) Use higher estrogen formulations or an alternative method or a secondary method Rifamycins (rifabutin, rifampin, rifapentine) Cytochrome P450 interaction (CYP3A4 induction) Non-hormonal contraception during therapy and for one cycle after treatment ends. Using a higher dose estrogen formulation is possible but less desirable. Drug Interactions and OC (cont) Agent Mechanism Action Recommended Antiviral protease inhibitors Cytochrome P450 interaction (CYP3A4 induction) Use higher estrogen formulations or an alternative/secondary method Benzodiazepines Metabolism of agents that undergo oxidation may be decreased resulting in increased benzodiazepam effects. May need to lower doses of benzodiazepines if CNS symptoms occur. Drug Interactions and OC (cont) Agent Mechanism Action Recommended Specific hypoglycemics Decreased contraceptive effect Use an alternative method or as a secondary method. Ascorbic acid Increased concentration of estrogen with possible increase in side effect. Avoid high doses of Vitamin C. Use low doses of estrogen. (Vitamin C doses of 1 gm or more daily) “For most women, including women who want to have children, contraception is not an option; it is a basic health care necessity.” Representative Louise Slaughter, US Congresswoman, New York www.brainyquote.com/quotes/authors/l/louise_slaughter.html#cLSMDXSjFSZPF43Z.99