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Update on Contraception 2014

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Presentation on theme: "Update on Contraception 2014"— Presentation transcript:

1 Update on Contraception 2014
Catherine Waits, MSN, APRN KCNPNM Conference April 2014

2 OBJECTIVES: Recognize that unintended pregnancy is a primary health concern List varieties of contraceptive methods. Identify risks, benefits and side effects of the various contraceptive methods. Identify contraceptive methods that are safe to use with certain medical conditions. Review principals of emergency contraception

3 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

4 * Standard Days Method: 5%, Two Day Method: 4%
Percentage of Women Experiencing Unintended Pregnancy in First Year of Using Contraceptive Talking points Graph shows the percentage of women experiencing an unintended pregnancy within the first year of use In the United States, 76% of all women use either the pill or male condom—which, as this slide shows, are not the most effective methods. [Kost, Lepkowski] “Typical use” is how effective each method is during actual use, including inconsistent and incorrect use. “Perfect use” is how effective the method can be if directions for use are followed at every act of intercourse. According to these data: [Trussell] For typical use, the most effective methods generally don’t require adherence. Methods that require adherence generally show a big difference between perfect-use and typical-use failure rates. Even the least effective methods are much more effective than no method at all. The most effective methods don’t protect against STIs. The most effective methods may be the hardest to access, especially for teens. References Hatcher RA, Trussell J, Stewart F, et al., eds. Contraceptive Technology. 19th edition. New York, NY: Ardent Media, Inc.; 2007. Trussell J. Reducing unintended pregnancy in the United States. Editorial. Contraception. 2008;77:1-5. Kost K, Singh S, Vaughan B, et al. Estimates of contraceptive failure from the 2002 National Survey of Family Growth. Contraception. 2008;77:10-21. Lepkowski JM, Mosher WD, Davis KE, et al. National Survey of Family Growth, Cycle 6: sample design, weighting, imputation, and variance estimation. National Center for Health Statistics. Vital Health Stat. 2006;2(142). - - - Original content for this slide submitted by ARHP’s Clinical Advisory Committee for the Breaking the Contraceptive Barrier program in April Original funding received from Duramed Research, Inc., a subsidiary of Barr Pharmaceuticals, through an educational grant. This slide is available at * Standard Days Method: 5%, Two Day Method: 4% Hatcher RA. Contraceptive Tech. 19th ed

5 FP-1 Increase the proportion of pregnancies that are intended
Intended pregnancy (females 15–44 years) 2002 Baseline: 51.0% 2020 Target: 56.0% Graph: Center on Children and Families at Brookings Report, Policy for Preventing Unplanned Pregnancy March 2012

6 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) 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)

7 Menstrual Cycle

8 The Menstrual Cycle The Menstrual Cycle is defined as the days between the first day of one menstrual bleeding period to the beginning of the next period. The cycle is regulated by 2 hormones secreted from the pituitary gland =the follicle stimulating hormone (FSH) and the luteinizing hormone (LH). These hormones stimulate the ovary to produce estrogen and progesterone. There are 3 phases of the menstrual cycle that affect both the ovaries and the uterus. In the FOLLICULAR PHASE, the follicles are stimulated to develop the ova and at the same time, the endrometium is in the PROLIFERATIVE PHASE (thickening & increasing blood flow to the endometrium). Late in the Follicular phase about 2-3 days before ovulation, the luteinzing hormone (LH) is stimulated and joins in the maturation of the oocyte and “building” the corpus luteum. The LH surge promotes the rupture of the follicle off the ovary into the fallopian tube. After the rupture of the follicle, the corpus luteum secretes progesterone changing the cycle to the LUTEAL PHASE which is dominated by progesterone rather than estrogen. PROGESTERONE SUPPRESSES NEW FOLLICULAR GROWTH. At the same time, the uterus is now in its SECRETORY PHASE (secreting proteins that will enhance and promote a pregnancy). If NO PREGNANCY, corpus luteum degenerates resulting in decline of progesterone and estrogen levels. Withdrawal of the hormones shrinks the endometrial lining causing sloughing and resulting in the MENSTRUAL PHASE. The bleeding is controlled by the formation of thrombin platelet plugs and RISING ESTROGEN LEVELS OF THE NEW CYCLE induces clot formation as well as regrowth of the endometrium . This is important to remember for conceptive side effects. Chart copied from http.// Hatcher RA & Namnoum AB (2004)

9 Contraceptive Hormonal Effects
ESTROGEN ↓ follicle-stimulating hormone release Suppresses LH surge Blocks ovulation Endometrial effects ↑ HDL cholesterol ↓ LDL cholesterol Triglycerides levels are slightly ↑ ↑ liver production of serum globulins involved in coagulation PROGESTIN ↓ luteinizing hormone secretion Blocks ovulation Thickens cervical mucus Slows tubal motility Induces endometrial atrophy ↑ LDL ↓ HDL & Triglycerides No effect on coagulation factors It is the effects of the hormonal contraceptives that concern us in prescribing for patients with medical conditions. All of the low dose oral contraceptives used today contain ethinyl estradiol. The metabolism of ethinyl estradiol variable according to the individual. Side effects individualized. Pharmacologic doses of decrease FSH release from the pituitary which suppressed the LH surge and blocks ovulation. Estrogen also induces localized edema in the endometrial lining reducing the probability of implantation. Estrogen favorably affects cholesterol levels which reduces the risk of coronary artery disease. The slight increase in triglyceride levels is not considered to be very significant except in certain situations. The most concerning of the estrogenic effects is the increased production of clotting factors such as factor 5, Factor 7 Factor 10 and fibrinogen. Thrombosis is the most serious side effect of the pill and this effect related to estrogen is dose related.

10 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

11 Contraceptive Options:
Barrier Methods Natural Hormonal Contraceptives


13 Combined Hormonal Contraceptive Methods “CHC”
[Insert Lecture Name Here] Combined Hormonal Contraceptive Methods “CHC” 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 Combined oral contraceptives (COCs) are a combination of estrogen and progestin. Three new OC formulations were introduced in the United States between 2000 and 2002: two containing reduced doses of estrogen (25 g) and the widely used progestins desogestrel and norgestimate (Apri or Desogen, Ortho Tri-Cyclen Lo), and one containing 30 g of estrogen and the novel progestin drospirenone (Yasmin). The novel progestin drospirenone is not derived from testosterone; rather, it is a spironolactone derivative. Like spironolactone, drospirenone has some antiandrogenic effects. In addition, it has anti-mineralocorticoid activity, which may reduce estrogen-induced sodium and water retention. Most COC formulations now contain 20 to 35 mcg of ethinyl estradiol plus one of seven available progestins. The reduction in estrogen and progestin dosages over the past 30 years has led to a significant reduction in COC-related health risk. These new formulations were developed with the goal of minimizing estrogen-related nonmenstrual side effects, such as breast tenderness, bloating, and nausea, and enhancing rather than diminishing cycle control (i.e., minimal breakthrough bleeding/spotting and amenorrhea). With ultra-low-dose OCs containing 20 g of estrogen, improved tolerability often was obtained at the expense of good cycle control. The new formulations have tried to achieve the optimum balance between the ultra-low dose OCs containing 20 g of estrogen and those containing higher estrogen doses of 30–35 g. A spearmint-flavored, chewable OC (Ovcon 35) was approved in 2003 and is expected to be launched in late spring Like other OCs, Ovcon 35 chewable comes in a blister package containing 21 active tablets and 7 inactive tablets. If chewed, it is recommended that the OC be followed by 8 ounces of liquid. It should be taken at the same time each day to ensure efficacy. More than 20 generic OCs are now available, such as Aviane (same as Alesse), Lessina (same as Levlite), Kariva (same as Mircette), Enpresse and Trivora (same as Triphasil-28), and Portia and Levora (same as Levlen). Mechanism of Action: Consider the “quick start” method when initiating oral contraceptives. A high number of unintended pregnancies are due to misuse or discontinuation of OCs. By the third month of use, the typical user misses three or more pills each cycle. These data are not presented to focus blame on OCs but to suggest that many women using daily methods are at risk for unintended pregnancy. The estrogen also works synergistically with the progestin to affect the uterine lining and cervical mucus production. The progestin in COCS is the main actor in preventing pregnancy. It suppresses the secretion of gonadotropin (mainly luteinizing hormone) by the pituitary gland. The estrogen primarily inhibits follicle-stimulating hormone secretion. Candidates: Women who want to regulate menses Women with dysmenorrheal and menorrhagia Advantages: Women who will use a daily method consistently COCs reduce the risk of ovarian cancer by 40-80% after ~ one year of use and decrease the risk from 10-12% annually thereafter. (Burkman) Even after discontinuing COC use, protection continues for years. COCs also reduce the risk of endometrial cancer by 40-50%, and like ovarian cancer, protection increases with duration of use. Most users of COCs have reduced menstrual flow and dysmenorrheal. Studies demonstrate 90 percent protection from ectopic pregnancy with current OC use. OCs can relieve vasomotor symptoms in most women. Three multicenter, randomized, placebo-controlled trial have demonstrated COC’s effectiveness in reducing acne. A reduced incidence of benign breast disease--including fibrocystic changes and fibro adenomas has been consistently shown. Contraindications: Possible Advantages: 1) May preserve bone density, and 2) May protect against iron deficiency anemia, ovarian cysts with higher doses, and pelvic inflammatory disease. Current or history of current ischemic heart disease Known thrombogenic mutations Multiple risk factors for arterial cardiovascular disease, such as smoking, diabetes, hypertension Vascular disease History of or current deep venous thrombosis or pulmonary embolism History of stroke Smoking (>10 cigarettes/day and age 35 or older) Hypertension (systolic ≥160 or diastolic ≥ 100) Complicated valvular heart disease Major surgery with prolonged immobilization Migraine headache with aura Severe cirrhosis Active viral hepatitis Current breast cancer Disadvantages: Breastfeeding <6 weeks postpartum Benign or malignant liver tumors Counseling: Obesity may impair the effectiveness of COCs. Breakthrough and /or irregular bleeding is the primary cause of discontinuation among new users. Other side effects include breast tenderness, nausea, and bloating. There is less likely to be side effects, such as nausea and breast tenderness, with low-dose pills. In fact, the incidence of these side effects is approximately 50 percent lower in users of 20 ug pills compared with a 35 ug pill. But the lower the dose the more likely breakthrough bleeding will occur. After breakthrough bleeding, breast tenderness and nausea are the leading causes of discontinuation. Many of these side effects usually disappear after the first few cycles of pill use. Fear of side effects, such as weight gain and nausea, is often the reason women discontinue COC. Emphasize that side effects abate with time. Even though weight gain is a primary concern of women using OCs, research shows that use of OCs does not substantially affect body weight for most women. Women also fear risks, such as breast cancer and venous thromboembolism. Review their risks. Breast cancer: There is confusion regarding the risk of breast cancer and OC use. Many women think that the findings of the Women’s Health Initiative regarding combination (estrogen/progestin) hormone replacement therapy apply to all hormones. Recent high-quality observational data from the Women’s Contraceptive and Reproductive Experiences (CARE) Study provide reassuring evidence that OC use does not increase breast cancer risk. The relative risk was 1.0 (95% CI = 0.8–1.0) for current OC users and 0.9 (95% CI = 0.8–1.0) for former users. These findings were not changed by duration and dosage of OC use, timing of use, age at use, or risk status based on family history. Likewise, a pooled analysis of data from WHO and New Zealand trials of DMPA found no overall increase in breast cancer risk. Weight gain: Pooled data from two, 6-cycle, multi-center, double-blind, placebo-controlled trials showed that 2.2% of 228 OC users and 2.1% of 234 placebo users reported weight gain. Likewise, a Cochrane Review of all English-language randomized controlled trials of at least 3 treatment cycles’ duration noted that 3 placebo-controlled trials found no evidence to support a causal association between combination OCs or a combination skin patch and weight gain. [Note: Redmond data were not included.] Their overall conclusion was that there was insufficient evidence to determine the effect of combination OCs on weight, but that no large effect was evident. In actual practice, however, clinicians appreciate that the effects of hormonal contraception on weight will vary from patient to patient, depending on a variety of physiological and lifestyle issues. Obesity and use of COCs are independent risk factors for venous thromboembolism. Venous thromboembolism: Use of combination OCs increases the risk of thromboembolism. However, the annual risk is low (1.0–3.0 per 10,000 women) and approximately half that associated with pregnancy (5.9 per 10,000). Another common concern is that OCs cause heart attack and stroke. This risk is related to the presence of other risk factors, especially smoking. In fact, OC use does not increase the risk of myocardial infarction or hemorrhagic stroke among healthy nonsmokers under age 35 who do not have other risk factors for these events, and is associated with only a slight increase in the risk of ischemic stroke. References Burkman RT, Fisher AC, LaGuardia KD. Effects of low-dose oral contraceptives on body weight: results of a randomized study of up to 13 cycles of use. J Reprod Med Nov;52(11): Burkman R, Schlesselman JJ, Zieman M. Safety concerns and health benefits associated with oral contraception. Am J Obstet Gynecol. 2004;190(Suppl):S5-S22. ACOG Committee on Practice Bulletins. No. 73. Use of Hormonal Contraception in Women with Coexisting Medical conditions. Obstet Gynecol. 2006;107: Davis A. Wysocki S. Clinician/patient interaction: communicating the benefits and risks of oral contraceptives. Contraception. 1999;59(1 Suppl):39S-42S. Burkman RT. Management of the Fibroid Uterus. Adv Obstet Gynecol. 1996;3: Farmer RDT, Preston TD. The risk of venous thromboembolism associated with low oestrogen oral contraceptives. J Obstet Gynecol. 1995;15: Goldzieher JW. The hypothalamo-pituitary-ovarian system. Pharmacology of the Contraceptive Steroids. (New York: Raven Press, 1994) Moghissi KS. Effects of microdose progestogens on endogenous gonadotrophic and steroid hormones, cervical mucus properties, vaginal cytology and endometrium. Fertil Steril. 1971;22(7): Gallo MF, Grimes DA, Schulz KF, Helmerhorst FM. Combination contraceptives: effects on weight (Cochrane Review). In: The Cochrane Library, Issue 4, Chichester, UK: John Wiley & Sons, Ltd. Kaunitz AM. Use of combination hormone replacement therapy in light of recent data from the Women’s Health Initiative. Medscape Women’s Health eJournal. 2002;7. Available at: Retrieved July 12, 2002. Hardman JG, Limbird LE (eds.) Goodman & Gillman’s The Pharmaceutical Basics of Therapeutics. Ninth edition. Section XIII: Hormones and hormone synthesis. New York: The McGraw-Hill Companies, Inc., 1996. Moghissi KS. Effects of microdose progestogens on endogenous gonadotrophic and steroid hormones, cervical mucus properties, vaginal cytology and endometrium. Fertil Steril. 1971;22(7): Martin SL, Curtis KM, Glasier AF. Combined hormonal contraception and bone health: a systematic review. Contraception. 2006;73(5): Marchbanks PA, McDonald JA, Wilson HG, et al. Oral contraceptives and the risk of breast cancer. N Engl J Med. 2002;346: Peterson HB, Lee NC. The health effects of oral contraceptives: misperceptions, controversies, and continuing good news. Clin Obstet Gynecol. 1989;32: National Association of Nurse Practitioners in Women’s Health (NPWH). National survey on weight gain and oral contraceptives. Washington, DC:NPWH, 1999. Mosher WD, Martinez GM, Chandra A, et al. Use of contraception and use of family planning services in the United States: Advance Data 2004 Dec 10;(350):17-52. Redmond GP, Olson WH, Lippman JS, Kafrissen ME, Jones TM, Jorizzo JL. Norgestimate and ethinyl estradiol in the treatment of acne vulgaris: a randomized, placebo-controlled trial. Obstet Gynecol. 1997;89: Redmond G, Godwin AJ, Olson W, Lippman JS. Use of placebo controls in an oral contraceptive trial: methodological issues and adverse event incidence. Contraception. 1999;60:81-85. Potter L, Oakley D, deLeon-Wong E, Canamar R. Measuring compliance among oral contraceptive users. Fam Plann Perspect. 1996:28: Rosenberg MJ, Waugh MS. Oral contraceptive discontinuation: a prospective evaluation of frequency and reasons. Am J Obstet Gynecol. 1998;179: Rosenberg MJ, Waugh MS, Long S. Unintended pregnancies and use, misuse and discontinuation of oral contraceptives. J Reprod Med. 1995;40: Rosenberg MJ, Meyers A, Roy V. Efficacy, cycle control, and side effects of low- and lower-dose oral contraceptives: a randomized trial of 20 ug and 35 ug estrogen preparations. Contraception. 2000;60: Spector TD, Hochberg MC. The protective effect of the oral contraceptive pill on rheumatoid arthritis: an overview of the analytic epidemiological studies using meta-analysis. J Clin Epidemiol. 1990;43(11): Skegg DC, Noonan EA, Paul C, et al. Depot medroxyprogesterone acetate and breast cancer. A pooled analysis of the World Health Organization and New Zealand studies. JAMA. 1995;273: Trussel J. Contraceptive efficacy. In: Hatcher RA, Trussel J, Nelson AL, et al. Contraceptive Technology: Nineteen Revised Edition. New York, NY: Ardent Media, 2007. WHO Medical Eligibility Criteria for Contraceptive Use, 3rd edition 2004. Original content for this slide submitted by Association of Reproductive Health Professionals in June Original funding received from the Association of Reproductive Health Professionals general operating funds. This slide is available at --- 54 mm 4 mm Dickey RP (2010) Zieman M (

14 Combined Hormonal Contraceptives
Benefits 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) 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


16 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 Summary


18 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)

19 Oral Contraceptive Products
Name Ethinyl Estradiol Progestin Characteristics LoSeasonique Loestrin 1/20 20 mcg Levonorgestrel 0.1 mg Norethindrone acetate 1 mg Regular or light menses 2-4 d Mild or no cramps Mircette Ortho Tricyclen Lo 25 mcg Desogestrel 0.15 mg Norgestimate 0.180/ 0.215/0.250 Regular or mod. menses 4-6 d Moderate cramps Ovral (Norinyl 1/35) 50 mcg 35 mcg Norgestrel 0.5 mg Norethindrone 1.0 mg Regular Heavy menses 6+ d Severe cramps Alesse Yaz 20 mg Drospirenone 3.0 mg Irregular menses. Acne, oily skin, hirsutism Ortho-Micronor Norethindrone 0.35 mg H/O excessive nausea & edema during pregnancy H/O fibroids; fibrocystic breasts H/O excessive pregnancy weight gain & varicose veins Depression; Premenstrual edema Ortho Novum 777 Norethindrone Weight less than 110 pounds (Ortho Novum 777) 35 mg Weight more than 160 # Dickey RP (2010) pg

20 Transdermal Contraceptive Patch

21 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) 21

22 Transdermal Contraceptive Patch
Advantages 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 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 Use a new location for each patch Apply to clean, dry skin Apply where it won’t be rubbed by clothing: on buttocks, abdomen, upper outer arm, upper torso Do not use on irritated or abraded skin Do not use on the breasts Avoid oils, creams, or cosmetics until after patch placement Bathe and swim as usual Anticipate more breast discomfort during the first 2 months Store at room temperature Do not cut, alter or damage the patch as if may alter contraceptive efficacy Do not flush a used patch into the water system; fold the used patch in half and place in the trash 22

23 Vaginal Contraceptive Ring

24 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 24

25 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. 25

26 Vaginal Ring Advantages Disadvantages Self-administered
Patient does not have to take daily Low dose estrogen Less side estrogenic side effects generally no nausea, or breast tenderness Does not affect lipoproteins Effective for all body types Steady-state hormone levels Shorter, lighter periods Some breast tenderness Weight neutral Increase in vaginal discharge Headache Vaginitis Must digitally self insert Nakajima 3rd Edition 2007 Contemporary Guide to Contraception: large multicenter multinational study 2322 women the three common problems during 1-yr study period were ha (5.8%) vaginitis (5.6%) and leukorrhea (4.8%) Devise related including foreign body sensation and coital problems and expulsion were the next most common (4.4%) 26

27 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 OC efficacy is not reduced by antibiotics generally used for acne or common infections but can be reduced by griseofulvin and antibiotics used to treat tuberculosis. Handout has a detailed list of medication interaction with contraceptives. 27

28 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) 28

29 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) 29

30 Oral Contraceptives and the Risk of Cardiovascular Event: Stroke, MI, VTE
Cardiovascular events, including VTE, stroke, and myocardial infarction (MI), although rare in absolute terms, are the most common major adverse events associated with combined hormonal contraceptives.1 However, the relative risk of these events varies substantially, depending on patient characteristics. Figure 10 presents the incidence of these events for women 30 to 34 years old. The risk is substantially higher for women who smoke and use OCs than for other women.1 Nonsmokers who use OCs have higher rates of nonfatal VTE than smokers who do not use OCs, but the latter population has higher rates of stroke and heart attack. Figure 10 also presents data on cardiovascular mortality, which varies similarly depending on patient characteristics. Again, the risk is substantially higher for OC users who smoke than for other women. Helping Your Patients Decide: Making Informed Health Choices About Hormonal Contraception (June 2006) Association of Reproductive Health Professionals

31 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) 31


33 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= ), 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) N of 53,297 women with breast cancer, 100,239 women without, from 54 epidemiologic studies. And a supportive study: Women’s CARE Study COCs & Breast Cancer Risk (n 5,000) Little evidence of risk; No overall effect of COCs by:– Duration of use– Age at first use– Time since last use– Estrogen dose– Positive family history March banks et al. Oral contraceptives and the risk of breast cancer. N Engle J Med 2002;346: 33

34 Progestin-Only Contraceptives

35 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 There are currently 9 different progestins used in oral contraceptives and 3 others used in the ring, patch and Implant products. Desogestrel, Norgestimate and Drospirenone have reduced androgenicity and do not adversely affect the cholesterol-lipoprotein in fact promotes favorable lipid changes. . Progestins promote contraception by decreasing the LH secretion and thus inhibits ovulation. Contraception is also influenced by the other organ effects. Progestin have no effect on coagulation.

36 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

37 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. ( )

38 Progestin Only Methods
Advantages Disadvantages 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 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 NAkajima, 3rd ed pg 85 Drug interaction with POPs: increased liver metabolism of steroids and render pops less effectiv e—use back up barrier method or consider other methoIn Latina women, the hypothesis is that unopposed prestin has a negative effect on insulin metabolism leading to resistance. 38

39 Progestin-Only Injection

40 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 3-month injectable (Depo-Provera): A 1-mL crystalline suspension of 150 mg of DMPA is injected intramuscularly into the deltoid or gluteus maximus muscle every 11–13 weeks. Mechanism of Action: As with other progestins it not only prevents ovulation; it also reduces ovarian production of estradiol. Candidates: DMPA is a good choice for women who want reversible, nondaily contraception DMPA does not require daily use. The convenience and high efficacy rate of DMPA has made this contraceptive method an increasingly popular with teens--the percentage of teens who had used DMPA increased from 10% in 1995 to 21% in 2002. Clinical situations in which estrogen is contraindicated include complicated migraine headaches, diabetes, smokers aged >age 35, and postpartum women. DMPA can be initiated immediately postpartum because it does not contain estrogen--it does not affect breastfeeding. The amenorrhea the majority of DMPA users experience may improve conditions such as menorrhagia, dysmenorrhia, and iron deficiency anemia. At least one-half of users develop amenorrhea within 12 months. Amenorrhea may be a desired lifestyle change. DMPA also can decrease the risk of dysfunctional menstrual bleeding in women who are overweight. But it is only appropriate for women who do not wish to conceive immediately after discontinuing it. The median time to conception for those who do conceive is 10 months following the last injection. Advantages: Reduces the risk of endometrial cancer by up to 80%, with continuing protection after discontinuation. Reduces risk of PID and uterine leiomyomata Can decrease the number and severity of crises in patients with sickle cell anemia. Contraindication: Known or suspected malignancy of the breast (WHO Medical Eligibility Criteria for Contraceptive Use, 3rd edition 2004). Disadvantages: Weight gain: The data suggests that weight gain with DMPA is varies from person to person. Some gain weight while others lose or maintain body weight. Menstrual irregularities: Most women have an altered menstrual cycle with DMPA, including irregular bleeding and spotting, and rarely heavy bleeding, for at least the first 3 months of use. Then, these menstrual changes decrease over time. By one year, up to 70% of women have amenorrhea. Bone mineral density: In 2004, the FDA issued a black box warning that DMPA use may lead to significant BMD loss, increasing the risk of future osteoporotic fractures. But evidence is mounting that BMD generally rebounds 2 to 3 years after DMPA discontinuation. This evidence of complete BMD recovery was observed regardless of ethnicity (black vs. mixed race), duration of injectable use, age during use, or injectable formulation used (DMPA vs. NET-EN). Health care providers and women should weigh concerns about temporary bone loss with DMPA’s convenience and well-established efficacy. Return to fertility: The median time to conception for those who do conceive is 10 months following the last injection. References Cromer BA, Lazebnik R, Rome E, et al. Double-blinded randomized controlled trial of estrogen supplementation in adolescent girls who receive depot medroxyprogesterone acetate for contraception. Am J Obstet Gynecol. 2005;192(1):42-47. Trussel J. Contraceptive failure in the United States. Contraception. 2004;70(2):89-96. Westhoff C. Depot-medroxyprogesterone acetate injection (Depo-Provera®): a highly effective contraceptive option with proven long-term safety. Contraception. 2003;68(2):75-87. Thomas DB, Ray RM. Depot-medroxyprogesterone acetate (DMPA) and risk of invasive adenocarcinomas and adenosquamous carcinomas of the uterine cervix. WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Contraception. 1995;52(5): Kaunitz AM. Current concepts regarding use of DMPA. J Reprod Med. 2002;47(9 Suppl): Cullins VE. Noncontraceptive benefits and therapeutic uses of depot medroxyprogesterone acetate. J Reprod Med. 1996;41(5 Suppl): Review. Rosenberg L et al. Bone status after cessation of use of injectable progestin contraceptives. Contraception 2007 Dec; 76:425. Kaunitz A, Shields W. Depo-Provera’s black box: time to reconsider? Contraception. 2005;72(3): FDA Talk Paper. Black box warning added concerning long-term use of Depo-Provera contraceptive injection. US Food and Drug Administration web site. Available at: WHO Medical Eligibility Criteria for Contraceptive Use, 3rd edition 2004. Leeman L. Medical barriers to effective contraception. Obstet Gynecol Clin N Amer. 34 (2007) Kaunitz AM, Arias R, McClung M. Bone density recovery after depot medroxyprogesterone acetate injectable contraception use. Contraception 77 (2008) World Health Organization. WHO statement on hormonal contraception and bone health. Available at: html. ACOG practice bulletin. No. 73: Use of hormonal contraception in women with coexisting medical conditions. Obstet Gynecol 2006;107:1453–72. Leeman L. Medical barriers to effective contraception. Obstet Gynecol Clin N Amer. 34 (2007) Trussel J. Contraceptive efficacy. In Hatcher RA, Trussel J, Nelson AL, Cates W, Stewart FH, Kowal D. Contraceptive Technology: Nineteen Revised Edition. New York, NY: Ardent Media, 2007. US Approved Prescribing Information for DMPA Contraceptive Injection, Pharmacia & Upjohn Co --- Original content for this slide submitted by Association of Reproductive Health Professionals in June Original funding received from the Association of Reproductive Health Professionals general operating funds. This slide is available at Dickey RP (2010) Zieman M ( 40

41 Contraceptive Injection
Advantages Disadvantages Irregular bleeding Amenorrhea Hypoestrogenism Vaginal dryness Acne Hirsutism Return to fertility may be delayed No protection from STI Weight gain Average of 5.4# in first year Bone mineral density effect Calcium either diet or supplement Weight bearing exercise Avoid Cigarette use Decreased menstrual bleeding/ cramping Improvement with endometriosis Reduces risk of endometrial cancer Reduces risk of ovarian cancer Safe to use with blood clotting disorders Good with seizure disorder Effective for physically challenged Decreases ectopic pregnancies Breast feeding is not compromised Private Zieman M, et al (2010)

42 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, Dear Healthcare Professional Letter1 - Pfizer] [November 18, Dear Healthcare Organization Leader Letter2 - Pfizer] [November, Label3 - Pfizer] 42

43 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.”

44 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

45 Contraceptive Implant

46 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 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 (

47 Contraceptive Implant
Advantages Disadvantages 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 Irregular bleeding No periods at all Requires clinician visit for insertion and removal Does not protect against sexually transmitted infections 47

48 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

49 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

50 Intrauterine Contraceptives

51 Mirena® Levonorgestrel-Releasing Intrauterine System (LNG-IUS)
Levonorgestrel 20 mcg releases every 24 hrs Efficacy Rate: Perfect Use=0.3 pregnancies/ 100 women Typical Use=0.3 pregnancies/ 100 women Mechanism of Action: Thickens cervical mucus Tubal fluid changes impair sperm & ovum migration Suppresses endometrium Inhibits ovulation Initiate method: Insert within 7 days of LMP; no backup needed Insert anytime in cycle and use backup method for 7 days Indicated for dysmenorrhea and heavy bleeding Endometrial protection during hormone or tamoxifen therapy Long-Acting Reversible Contraception Duration of use: 5 years 51

52 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 Talking Points: The exact mechanism of action of the copper IUD is not clear; however, substantial evidence suggests that the primary mechanism of action is prevention of fertilization. Inhibition of implantation would explain the high effectiveness of copper IUDs to act as emergency contraception. References: Alvarez F, Brache V, Fernandez E, et al. New insights on the mode of action of intrauterine contraceptive devices in women. Fertil Steril. 1988;49:768. Segal SJ, Alvarez-Sanchez F, Adejuwon CA, et al. Absence of chorionic gonadotropin in sera of women who use intrauterine devices. Fertil Steril. 1985;44:214. American College of Obstetricians and Gynecologists. Statement on Contraceptive Methods. Washington, DC: ACOG; 1998. 52

53 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 53

54 Intrauterine Contraception
Advantages Disadvantages Highly effective birth control Long lasting No daily, weekly, monthly responsibility With Mirena, bleeding changes Weight neutral Cost effective May be used with nulliparous Painful to insert Possibility of perforation Possibility of expulsion Professional assistance to insert and remove Amenorrhea or Dysmenorrhea Ovarian cysts No protection against STI

55 Male and Female Barrier Contraceptives

56 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%

57 Male Condom Latex condom Polyurethane condom Advantages Disadvantages
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 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 The male condom can be used with other contraceptive methods to increase contraceptive efficacy. It also helps protect against STDs, including HIV/AIDS. Men and their partners who are sensitive to latex can switch to a nonlatex condom. Mechanism of Action: Barrier method Advantages: Protection against STIs Accessibility - no prescription required and available at a wide variety of stores Low cost Male participation Hygiene Minimal side effects Disadvantages: Reduced sensitivity in genital area Problems with erection Embarrassment when purchasing condoms Required with every act of intercourse, reduces spontaneity Latex allergy Male resistance to use Counseling: Discuss with patient How to use effectively How to integrate condom use into coitus How to negotiate condom use That condoms should be used for all sexual activities that can transmit STIs New condom should be used for each act (anal, vaginal, oral) Discuss using dual methods, when appropriate. Tailor patient counseling to client’s own risk factors, abilities, needs and attitudes. Inform client of how to obtain emergency contraception References Hatzell T, Feldblum PJ. The female condom: beyond acceptability to public health impact. Sex Transm Dis Nov;28(11): Trussel J, Sturgen K, Strickler J, Dominik R. Comparative contraceptive efficacy of the female condom and other barrier methods. Fam Plann Perspect. 1994;26:66-72. Trussel J. Contraceptive efficacy. In: Hatcher RA, Trussel J, Nelson AL, Cates W, Stewart FH, Kowal D. Contraceptive Technology: Nineteen Revised Edition. New York, NY: Ardent Media, 2007. --- Original content for this slide submitted by Association of Reproductive Health Professionals in June Original funding received from the Association of Reproductive Health Professionals general operating funds. This slide is available at

58 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 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 Approved by the FDA in 2003. It does not need to remain in place afterward; instead it can be removed and discarded immediately. The condom is coated on the inside with a silicone-based lubricant. Additional lubricant is provided for the outside of the condom. Mechanism of Action: Barrier method Advantages: Privacy Protection against STIs and HIV/AIDS. Low cost Can be inserted up to 8 hours before intercourse Can be used during menses Contraindications: Simultaneous male condom use because the two materials can adhere to each other and cause slippage or breakage of one or both devices. Abnormalities in vaginal anatomy that interfere with placement Disadvantages: Vaginal discomfort, penile irritation Required with every act of intercourse Available over the counter and intended for one-time use only. Counseling: Give patient opportunity to practice inserting and removing during visit Inform patient on how to obtain emergency contraception References Hatzell T, Feldblum PJ. The female condom: beyond acceptability to public health impact. Sex Transm Dis 2001 Nov;28(11): Trussel J, Sturgen K, Strickler J, Dominik R. Comparative contraceptive efficacy of the female condom and other barrier methods. Fam Plann Perspect 1994;26:66-72. Trussel J. Contraceptive efficacy. In Hatcher RA, Trussel J, Nelson AL, Cates W, Stewart FH, Kowal D. Contraceptive Technology: Nineteen Revised Edition. New York, NY: Ardent Media, 2007. --- Original content for this slide submitted by Association of Reproductive Health Professionals in June Original funding received from the Association of Reproductive Health Professionals general operating funds. This slide is available at *Division of Reproductive Health, National Center for Chronic Disease and Prevention and Health Promotion, 2013

59 Sponge Advantages Disadvantages
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 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 The vaginal sponge is a small, circular, polyurethane sponge that contains 1 gram of nonoxynol-9 spermicide. It has a dimple on one side that fits over the cervix and a loop on the opposite side to aid in removal. It is recommended to use spermicide with the vaginal sponge. Mechanism of Action: Barrier method Advantages: Effective for up to 24 hours, regardless of the number of times intercourse occurs during that time. Disadvantages: Each sponge can be used only once. After the last act of intercourse, it should be left in place for at least 6 hours but for no more than hours . Some women are sensitive to the spermicide used in the vaginal sponge. If it is left in place for longer than hours, the risk of vaginal yeast infection may be increased. Some women have vaginal dryness with sponge use. Counseling: Inform patient of how to obtain emergency contraception References Engender Health. Contraceptive Method Effectiveness. New York, New York Available from: Trussel J. Contraceptive efficacy. In Hatcher RA, Trussel J, Nelson AL, Cates W, Stewart FH, Kowal D. Contraceptive Technology: Nineteen Revised Edition. New York, NY: Ardent Media, 2007. Image from Wikimedia Commons --- Original content for this slide submitted by Association of Reproductive Health Professionals in June Original funding received from the Association of Reproductive Health Professionals general operating funds. This slide is available at

60 [Insert Lecture Name Here]
Effective Spermicide Advantages Disadvantages No prescription required Increased lubrication during intercourse VCF Film convenient and discreet 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 Available as creams, gels, film, foam, and suppositories containing nonoxynol-9 Used alone or with a barrier method Acting as barriers, spermicides prevent sperm from entering the cervical os and as chemical detergents that attack the sperm flagella and body, reducing mobility and disrupting fructolytic activity, which jeopardizes nourishment. Films and suppositories require 10–15 minutes for activation, which may interfere with lovemaking. Use of a barrier method (diaphragm, cervical cap, or male or female condom) increases the efficacy of spermicides. References Roddy RE, Zekeng L, Ryan KA, Tamouf U, Weir SS, Wong EL. A controlled trial of nonoxynol 9 film to reduce male-to-female transmission of sexually transmitted diseases. N Engl J Med 1998;339(8): Trussel J. Contraceptive efficacy. In Hatcher RA, Trussel J, Nelson AL, Cates W, Stewart FH, Kowal D. Contraceptive Technology: Nineteen Revised Edition. New York, NY: Ardent Media, 2007. --- Original content for this slide submitted by Association of Reproductive Health Professionals in June Original funding received from the Association of Reproductive Health Professionals general operating funds. This slide is available at

61 Diaphragm Advantages Disadvantages Used with a spermicide
Can be inserted hours before intercourse Does not require removal between acts of intercourse Low Cost 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 Diaphragms require a prescription from a health care provider. Most types are made of latex, but a silicone diaphragm is available for patients with latex allergy. Diaphragms come in diameters ranging from 50 to 95 mm, and a woman must be fitted for the correct size before she uses the device. Patients should be refitted after pregnancy or childbirth or if they gain or lose 10 or more pounds. A spermicide is applied to the diaphragm before use. The diaphragm can be inserted up to 6 hours before intercourse and should be left in place for at least 6 hours after the last act of intercourse. If the woman has additional acts of intercourse before 6 hours have elapsed, she should insert fresh spermicide into the vagina without removing the device. The diaphragm should not be left in place for more than 24 hours, because doing so is associated with an increased risk of toxic shock syndrome. Women should never use any type of oil-based lubricant (e.g., petroleum-based products, mineral or baby oil, or vegetable oil) with the latex diaphragm, because these substances will dissolve the latex. References Fihn SD, Latham RH, Roberts P, Running K, Stamm WE. Association between diaphragm use and urinary tract infection. JAMA 1985;254(2):240ミ5. d’Oro LC, Parazzini F, Naldi L, La Vecchia C. Barrier methods of contraception, spermicides, and sexually transmitted diseases: a review. Genitourin Med 1994;70(6):410-7. Trussel J. Contraceptive efficacy. In Hatcher RA, Trussel J, Nelson AL, Cates W, Stewart FH, Kowal D. Contraceptive Technology: Nineteen Revised Edition. New York, NY: Ardent Media, 2007. --- Original content for this slide submitted by Association of Reproductive Health Professionals in June Original funding received from the Association of Reproductive Health Professionals general operating funds. This slide is available at Used with a spermicide

62 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 62

63 Natural Contraceptive Methods

64 Efficacy of Contraceptives
Natural Contraceptives Efficacy Abstinence Perfect Use: 1-9/ 100; Typical Use= 20 pregnancies/ 100 women Breastfeeding/ LAM (Lactational Amenorrhea Method) 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. 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)

65 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 65

66 LAM: Benefits vs. Limitations
Effective (1-2 pregnancies per 100 women during first 6 months of use) Effective immediately Does not interfere with sexual intercourse No systemic side effects No medical supervision necessary No supplies required No cost involved User-dependent (requires following instructions regarding breastfeeding practices) May be difficult to practice due to social circumstances Highly effective only until menses return or up to 6 months Does not protect against STDs (e.g., HBV, HIV/AIDS) 66

67 Methods of Fertility Awareness/NFP
Calendar/Standard Days Basal Body Temperature (BBT) Cervical Mucus (Billings) Symptothermal (BBT + cervical mucus) 67

68 Natural Family Planning (NFP)
Mechanism of Action Conditions Requiring Precaution For contraception: 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. Irregular menses Persistent vaginal discharge Breastfeeding 68

69 Natural Family Planning (NFP
Benefits Limitations Can be used to prevent or achieve pregnancy No method-related health risks No systemic side effects Inexpensive 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) 69

70 Sperm do not enter the vagina and fertilization is prevented
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 Limitations Effective immediately Does not affect breastfeeding Can be used as backup to other methods No method-related health risks Always available No cost involved Effectiveness depends on willingness of couple to use method with every act of intercourse Effectiveness may be further decreased by sperm from a recent (< 24 hours) ejaculation remaining in the penis (urethra) May diminish sexual pleasure Does not protect against STDs (e.g., HBV, HIV/AIDS) 70

71 Abstinence Mechanism Effectiveness Complications
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 71

72 Sterilization Methods

73 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.

74 Non-Surgical Tubal Occlusion
Brand name: Essure® Tubal sterilization through hysteroscopic placement of micro-coil in fallopian tubes

75 Sterilization Advantages Disadvantages Permanence
Ideal for those desiring no more children Quick recovery Lack of significant long-term effects Cost-effective No need to remember to use contraception before intercourse No need for partner compliance High degree of safety; low mortality rates Permanence Reversal is expensive, requires major surgery, and is not guaranteed Regret for the decision Expense at time of procedure Procedure requires aseptic conditions, surgical equipment, trained clinicians, and anesthesia Does not protect against HIV or other sexually transmitted infections

76 Male Sterilization: Vasectomy
Mechanism of Action: Blocks vas deferens (ejaculatory duct) Sperm are not present in the ejaculate Types No-scalpel technique (preferred) Incisional Vasectomy is a simple, safe surgical procedure for permanent male fertility control. The tube (called a “vas”) which leads from the testicle is cut and sealed in order to stop sperm from leaving. The procedure usually takes about 10 to 20 minutes. Since the procedure simply interrupts the delivery of sperm it does not change hormonal function – leaving sexual drive and potency unaffected. The No-Scalpel vasectomy is a technique used to do the vasectomy through one single puncture. The puncture is made in the scrotum and requires no suturing or stitches. The primary difference compared to the conventional vasectomy is that the vas deferens is controlled and grasped by the surgeon in a less traumatic manner. This results in less pain and fewer postoperative complications. This procedure is done with the aid of a local anesthetic called ‘Xylocaine’ (similar to ‘Novocaine’).

77 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.

78 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

79 What If…? …the condom broke or slipped off...
…you forgot your regular birth control... Talking Points Women may need emergency contraception for a number of reasons… - - - Original content for this slide submitted by James Trussell, PhD, in May Original funding received from the Davie and Lucille Packard Foundation. Revised content for this slide submitted by James Trussell, PhD, in April Last reviewed/updated by Linda Dominguez, RN-C, NP, Don Downing, RPh, and James Trussell, PhD, in April This slide is available at …you were forced to have sex...

80 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) 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) 80

81 Choosing Contraceptives

82 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?”

83 Hormonal Contraceptives: Coexisting Medical Conditions
Talking points Hypertension According to WHO guidelines, combined oral contraceptives (COCs) should not be used in women with hypertension whose blood pressure is >160 (systolic) or >100 (diastolic). COCs are not usually recommended unless other methods are not available or acceptable for women with hypertension above those levels. [WHO] Migraine [WHO] Advantages of COCs generally outweigh risks in women who have migraine without aura and are younger than 35. For older women without aura, COCs are usually not recommended unless other methods are not available or acceptable. COCs should not be used in women of any age who have migraine with aura. Diabetes [WHO] COCs can be used without restriction in women who have a history of gestational diabetes only. Advantages of COCs generally outweigh risks in women who have diabetes without vascular disease. COCs are not usually recommended unless other methods are not available or acceptable for women with end-organ damage or diabetes of more than 20 years’ duration. Obesity Obesity (body mass index of at least 30 kg per m2) may impair the effectiveness of combination oral and transdermal contraceptives. However, the incrementally higher failure rates in these patients should not exclude the use of these contraceptives in favor of less effective methods. [Armstrong; ACOG] References Armstrong C. ACOG releases guidelines on hormonal contraceptives in women with coexisting medical conditions. Am Fam Physician. 2007;75(8). ACOG Committee on Practice Bulletins–Gynecology. Obstet Gynecol. 2006;107(6): World Health Organization. Medical eligibility criteria for contraceptive use. 3rd edition Geneva, Switzerland. - - - Original content for this slide submitted by ARHP’s Clinical Advisory Committee for the Breaking the Contraceptive Barrier program in April Original funding received from Duramed Research, Inc., a subsidiary of Barr Pharmaceuticals, through an educational grant. This slide is available at

84 MEC 1: Can use. No restriction.
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. To assist clinicians in prudent selection of birth control methods, the WHO initiated a work group of clinicians around the world to develop guidelines for medical eligibly criterion for contraceptive use. The work group has identified more than 120 conditions with recommendations for each health condition and appropriate birth control methods. This third edition of the document is based on the recommendations of an expert Working Group meeting held at WHO on 21–24 October 2003, that brought together 36 participants from 18 countries, including representatives of many agencies and organizations. You can access the guidelines on line. The categories are as follows: It is a simple quick reference when you need a tool to assist in clinical judgment. Another handy reference is the Pocket Guide to Managing Contraception which has the guidelines copied. 84

85 US MEC with Certain Medical Conditions
TCu-380A CHC POC Hypertension (controlled=140/90) 1 3 2 History of DVT or pulmonary embolism 4 Varicose veins Stroke Severe valvular heart disease (complicated) HIV infection AIDS (clinically well on antiretroviral therapy) Check drug interactions Headaches-migraine with aura Postpartum not breast feeding < 21 days 3/4 Smoker > 35 y/o US Medical Eligibility Criteria for Contraceptive Use. 2010 85

86 Cardiovascular Disease: Conditions that increase risk of CVD
Diabetes HTN Thrombophilias Obesity Migraine headaches Immbolization Valvular Disease These are underlying conditions that with the addition of combined hormonal products could increase the risk of thrombosis, or myocardial infarction.

87 Diabetes CHCs do not significantly affect glycemic control
Are combination hormonal contraceptives (CHC) safe for women with diabetes? YES DO NOT LIMIT USE OF CHC CHCs do not significantly affect glycemic control CHCs do not accelerate diabetic vascular disease CHCs do not precipitate the risk of developing DM Non-SMOKERS Otherwise healthy: ø HTN ø nephropathy ø neuropathy ø vascular disease Pregnancy is women with diabetes is a/w an array of serious maternal and perinatal complications. For this reason, helping your diabetic patient choose effective birth control is important. COCs slightly raise glucose levels although but not enough to be out of control. Hatcher cites in Contemporary OB/GYN article that several case controlled studies of insulin dependent women have shown that OC do not affect glycemic control, HbGA1C or progression of disease over time. Avoid using combination methods if your patient has cardiovascular risk factors, current vascular disease or long standing disease, greater than 20 years duration. It is safe to use COC with pts with a history of Gestational Diabetes.

88 Headache What kind of HEADACHE is it? Nausea/ Vomiting Photophobia
Migraine w/ Aura Migraine Visual disturbance in both eyes Unilateral numbness Flashing or moving scotoma "Pins & needles" in extremities Unilateral weakness Aphasia or other speech difficulties Nausea/ Vomiting Photophobia Watery Eyes Taste or smell sensations Differentiating headache is important in prescribing hormonal contraception. Most H/A are non-vascular with little or no central nervous system involvement. Migraines can be with or without aura. It is important to R/O aura in your history. Aura indicates a focal neurologic dysfunction. The dx criterion for aura must have at least 2 of the sx listed. Each symptom starts gradually and lasts 5 to 60 min. typically 30 min. All sx are reversible. Aura consists of at least one of the following without motor weakness: visual sx (flickering lights, spots or lines, loss of vision) Most auras are visual=zigzag lines. Scotoma is a bright spot centralized gradually changing into a C shape. Sensory symptoms pins and needles or numbness. And Speech disturbances. Only the presence of aura makes a woman at higher risk of stroke not a regular migraine.

89 What to prescribe with Headaches?
Condition COC + Patch & Ring Depo-Provera Mirena Implanon Progestin-only pills Non-migraine headaches 1/2 1 Migraine w/o aura, age <35 2/3 2 Migraine w/o aura, age >35 3/4 Migraine with aura, any age 4 Combination estrogen products are contraindicated at any age foe women with aura because migraine with aura increases platelet aggregation coupled with the use of exogenous estrogens significantly puts the woman at risk for stroke. If H/A are associated or exacerbated by menstruation, or the placebo week of pills, consider continuous dose pills such as Seasonique or Lybrel. There is some concern that severe H/A may increase with Depo and Implants. ACOG guidelines state that Combined Hormone products may be used by women with migr H/A without aura, do not smoke, are otherwise healthy and less than age 35. ACOG guidelines further state that POP methods may be for women with aura but who have no other risk factors for stroke such as smoking, or hypertension. IUCs either Mirena or Paragard CopperT is safe to use for either type of headache. U.S Medical Eligibility Criteria for Contraception. 2010

90 Postpartum and Breastfeeding
CHC Progestin Implant DMPA Cu-IUD LNG- IUS Breastfeeding < 6 weeks PP 4 3 *  6 weeks to months PP 1 Postpartum < 21 days 3-4 wks > 4 wks * See below.

91 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) The biggest concern with seizure disorder is the drug-drug interaction with the anticonvulsant medications and the oral contraceptives both combined and progestin only pills. Some AEDs will decrease the efficacy of low dose pills, patch, ring and POPs increasing risk of pregnancy for the women with seizure disorders. Depo has a high enough dose of progestin to not be affected by the P450 enzyme metabolism of such drugs as Phenobarbital, phenytoin, carbamazepine, oxcarbazepine, felbamate or topiramate. Depo raises the seizure threshold and may actually reduce the number of seizures experienced.

92 Improving Contraceptive Compliance

93 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 Talking Points: Clinicians can help patients select a contraceptive option that they will be able to use successfully by first discussing their future fertility plans. Clearly, long-term contraceptive options, such as DMPA injection or an IUD, would not be appropriate choices for a woman who is considering a pregnancy within the next year or two. It is also important to discuss the patient’s positive and negative experiences with contraceptive methods used in the past. Does she have difficulty with daily pill-taking? Is she reluctant to insert a device such as the ring, diaphragm, or cervical cap into her vagina? Has her partner expressed any contraceptive preferences? - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for Contraception and the Well-Woman Visit in March Original funding received from Ortho-McNeil through an unrestricted educational grant. Last reviewed/updated by Chris Knutson, RN-C, MN, ANP, Anne Moore, MSN, RNC, FAANP, and Anita L. Nelson, MD in January 2007.

94 Quick Start Method Talking points
Another barrier to starting hormonal contraceptives is the notion that women must wait until the Sunday after their menses (for OCs) or for a follow-up visit (for IUD insertion). [Leeman] This delay can cause some women never to start the method they wanted and result in some pregnancies during the waiting period. [Leeman] An alternative is the Quick Start approach: If last menstrual period (LMP) was within the last 5 days, the method can be started immediately. If LMP was more than 5 days ago and a pregnancy test is negative, assess the last episode of unprotected sex to determine if EC is required (or immediately insert copper IUD). Instruct women who are using the pill, patch, ring, injection, or implant to use backup contraception for the first 7 days. The Quick Start method: Significantly improves the continuation rate for OCs. [Westoff] Produces better compliance at 3 months in adolescents. [Lara-Torre] References Leeman L. Medical barriers to effective contraception. Obstet Gynecol Clin N Am. 2007;34:19-29. Westoff C, Kerns J, Morroni C, et al. Quick start: novel oral contraceptive initiation method. Contraception. 2002;66:141-5. Lara-Torre E, Schroeder B. Adolescent compliance and side effects with quick start initiation of oral contraceptive pills. Contraception. 2002;66:81-5. - - - Original content for this slide submitted by ARHP’s Clinical Advisory Committee for the Breaking the Contraceptive Barrier program in April Original funding received from Duramed Research, Inc., a subsidiary of Barr Pharmaceuticals, through an educational grant. This slide is available at


96 Patient Follow-up Schedule a recheck visit Ask:
[Insert Lecture Name Here] 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? After a woman initiates a new method of contraception, short-term follow-up can increase successful use of the method. During a recheck visit occurring within six weeks to several months of when the patient begins using the new method, health care providers can review compliance issues (particularly for OC, patch, and ring users), concerns about side effect (particularly bleeding changes), and in the case of IUD users, to ensure the device remains in place. The visit can be done as a 15-minute express (i.e., no examination) office visit in which the patient is asked if she is satisfied with her contraceptive method, if there is anything she would change, if she is having bleeding problems or any other side effects. This follow-up visit is especially useful for teenage patients, who often use contraception sporadically and may be ambivalent about pregnancy. Women who are restarting a contraceptive method may not this short-term follow-up. Sometimes the follow-up can be conducted by telephone or . Depending on the patient, a postcard can be sent as a reminder that it has been three months since her visit and that she should call the office if she has any questions or concerns. Nurses and medical assistants should be trained to deal with basic questions about use of the patch, ring, OC, or three-month injectable. These can be documented in the patient’s chart, and the clinician can be consulted as needed. References: Association of Reproductive Health Professionals. Clinical Proceedings: Periodic Well-Woman Visit: Individualized Contraceptive Care. April 2004. --- Original content for this slide submitted by Association of Reproductive Health Professionals in June Original funding received from the Association of Reproductive Health Professionals general operating funds. This slide is available at Slide 96

97 Missed Pills (combined OCs)
Action Advised <12 hrs (late for dose) 12-24 hrs (missed 1 pill) >24 hrs (missed 2 pills) >48 hrs (>2 pills missed) Take Missed dose ASAP Yes 1,2 Yes Take “make-up” dose NA1,2 Yes1,2 Yes1 No2 No Use backup contraception No1,2 No1 Yes – 7 days2 Yes – 7 days1,2 Begin next cycle No change In wk 3 -- begin day 22 97

98 “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) 98

99 Drug Interactions and OC
Agent 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 back-up 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. 99

100 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) Non-hormonal contraception during therapy and for one cycle after treatment ends. Using a higher dose estrogen formulation is possible but less desirable. 100

101 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. 101

102 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 (Vitamin C doses of 1 gm or more daily) Increased concentration of estrogen with possible increase in side effect. Avoid high doses of Vitamin C. Use low doses of estrogen. 102

103 Representative Louise Slaughter, US Congresswoman, New York
“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

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