Contraception, Sterilization and Abortion

Contraception, Sterilization and Abortion
Alternatives, Counseling and Management Suzanne Trupin, MD Women’s Health Practice Clinical Professor of Obstetrics and Gynecology

Contraceptive Practices in USA
The typical American woman wants only two children; she spends roughly five years pregnant or trying to become pregnant, and three decades trying to avoid unwanted pregnancy. Yet many women find it difficult to practice contraception consistently or correctly over the course of their entire reproductive lives and lack the information and services that would assist them in doing so. As a result, roughly one in three American women will have had an abortion by age 45.

Counseling: GATHER Greet the patient in a warm and friendly manner, help her to feel at ease (Gather information on what she knows) Ask the patient about her needs and goals, STI risks nondirective counseling improves outcomes Tell the patient about her choices Help her decide Explain the correct use of the method or drug being prescribed Repeat important instructions and set up Return appointments

World Population Growth
Oct 12th 1999 we reached 6 billion, US just reached 300 million this year

Mourning Picture for Polly Botsford and Her Children (c. 1813)

Medical Evaluation for Contraception Prescription: WHO
Class A: Mandatory Pelvic for IUD, Cervical Cap and Diaphragm, Sterilization STI risk for IUD BP screening for women getting sterilization Class B: Contributes substantially to safe and effective use, but consider context Hb for IUD and Sterilization Class C: does not contribute substantially to safe and effective use of the method 100 million women world wide use OCs, 10 million americans

U.S. Pregnancies: Unintended vs. Intended
Slide 7 U.S. Pregnancies: Unintended vs. Intended Intended 51% Unintended 49%: Unintended births 22.5% 10,000 births/d in US, with 2100 experiencing major pg related complications before labork 2500 get a C/S and experience minor pg related complications Unintended pregnancy, which threatens the health of women, is a persistent, serious problem in the United States. To call unintended pregnancy an on-going epidemic just hints at the magnitude of the problem. Half of all pregnancies are unintended. Half of these end in elective abortion.5 This enormous rate of unintended pregnancies persists despite a number of contraceptive methods that have a failure rate of less than 1% in typical use. The only explanations are that women are not being adequately informed about the availability of effective contraceptive methods or women are not using effective methods consistently. The data suggest that there is an important failure of the interaction between health care providers and women to provide protection against unintended pregnancy. Elective Abortions 26.5% Henshaw: Fam Plann Perspect 1998;30:24-29.

Incidence of Fatal Complication
Slide 12 Incidence of Fatal Complication 11 2.6 It is reasonable to assume that sexually active couples who do not want pregnancy but who do not consistently employ an effective method of birth control are misinformed about—or are failing to face—the risks. Contraception should be employed in every sexual encounter when pregnancy is not desired. Women who express concern about the potential safety problems of birth control often fail to recognize the far greater risks of child birth. In addition to the emotional, financial, and social impact of continuing an unintended pregnancy, there are measurable health risks. These include a many-fold greater increase in risk of death due to a complication.9 1.5 Exposure Per 100,000 Woman Years Ory Fam Plann Perspect 1983;15:50-56.

Long-Term Reversible Contraception: A dialogue among Andrew M
Long-Term Reversible Contraception: A dialogue among Andrew M. Kaunitz MD, David A. Grimes, MD, and Anita L. Nelson, MD, held on October 29, OBG Management: S1-S10, December 2006.

Cost Estimates of Contraception & Pregnancy over 5 Years: No method over 5 yrs: unintended pg at cost of %14, 663 Cost is an important consideration for many women and for health maintenance organizations that reimburse for contraception. It is important to consider not only the purchase cost, but also the costs related to failure rates and duration of efficacy.37 The new monthly combination injectable falls near the low end of the cost spectrum, and compares favorably with many other highly effective, reversible methods of contraception. Trussel: Am J Public Health, 1995;85:

Categories of Contraceptive Risk
WHO Category 4 (old ‘contraindications’, now ‘refrain from use’) Condition which represents an unacceptable health risk if the contraceptive method is used. Do not use the method. WHO Category 3 (exercise caution) A condition where the theoretical or proven risks usually outweigh the advantages. Use of method is not usually recommended WHO Category 2 (advantages outweigh risks) Generally use the method with clinical judgement WHO Category 1 (no restrictions)

Use of Contraception with Coexisting Medical Conditions
FDA package labeling is the same for POP as COC without supporting evidence in many cases Current labeling for Norethindrone POP no longer lists history of thromobembolism as contraindication but does for norgesterel POP

Conditions that expose a woman to increased risk as a result of unintended pregnancy
Breast cancer or Estrogen Dependent Neoplasia Complicated valvular heart disease Diabetes: Vascular Complications

WHO Category 4 most apply to COC, R, P
Known thromobegenic mutations do not use COC or CIC Uterine Fibroids with cavity distortion do not use Cu-IUD or LGN-IUD PID or purulent cervicitis or active GC or CT do not Initiate IUDs For conditions of high risk of HIV and AIDS spermacide use is a category 4 Cerebrovascular or coronary artery disease multiple risk factors Migraines with Aura or migraines over the age of 35 Lactation (<6 weeks postpartum) do not use COC, P, R Liver disease Headaches with focal neurologic symptoms Major surgery and prolonged immobilization Age >35 years and smoke >14 cigarettes per day or more do not use COC, P, R Hypertension (blood pressure of >160/100 mmHg or concomitant vascular disease) Venous thromboembolism history Major surgery with prolonged immobilization Venous thromboembolism* Cerebrovascular or coronary artery disease* Hypertriglyceridemia (>350 mg) Structural heart disease Diabetes with complications Breast cancer* Pregnancy*Lactation (<6 weeks postpartum) Liver disease Headaches with focal neurologic symptoms Major surgery and prolonged immobilization Age >35 years and smoke 20 cigarettes per day or more Hypertension (blood pressure of >160/100 mmHg or concomitant vascular disease)

WHO Category 3 (exercise caution)
Postpartum <21 days Lactation (6 weeks to 6 months) Age >35 years and smoke <15 cigarettes per day History of breast cancer but no recurrence in past 5 year Interacting drugs (that affect liver enzymes) Gallbladder disease

WHO Category 2 (advantages outweigh risks)
CIN Severe headaches after initiation of oral contraceptive pills Undiagnosed vaginal or uterine bleeding Diabetes mellitus Major surgery without prolonged immobilization Sickle-cell disease or sickle-cell hemoglobin C disease Blood pressure of 140/100 to 159/109 mm Hg Undiagnosed breast mass Obesity Age >40 years High BP in Pregnancy Conditions predisposing to medication noncompliance Family history of lipid disorders Family history of premature myocardial infarction or DVT Uncomplicated valvular heart disease

WHO Category 1 (no restrictions)
Postpartum >=21 days Pos-tabortion, with abortion performed in first or second trimester History of gestational diabetes Varicose veins Mild headaches Irregular vaginal bleeding patterns without anemia Past history of PID Current or recent history of PID Current or recent history of STD Vaginitis without purulent cervicitis Increased risk of STD HIV-positive or at high risk for HIV infection or AIDS Benign breast disease Family history of breast cancer or endometrial or ovarian cancer Cervical ectropion Viral hepatitis carrier Uterine fibroids Past ectopic pregnancy Thyroid conditions

Oral Contraceptives and Shorter Acting Steroid Contraception
Oral Contraception Oral Contraceptives and Shorter Acting Steroid Contraception 60% of US Women have misconceptions regarding oral contraceptives and yet most women can safely use OrCont until Menopause

Contraceptive Cases A 16 year old wants pills but refuses a pelvic, do you give them to her? 19 year old U of I sophomore says her menses comes on Sunday, so she wants to know does she start this Sunday or next? To take a break from pills a 21 year old stops the pills for a month while her partner is off visiting medical schools. How long a break does she need? A 16 year old presents with her mother requesting pills for acne, the mother insists you give her the ones that are the cheapest, the patient wants the ones she sees on TV that are good for your skin, which do you choose? A 23 year old is getting monthly PMDD, what do you advise? A 55 year old comes in on birth control pills from her previous physician, is this dangerous? A 26 year old with three previous ME presents for contraceptive advice, she has a sister and a mom with breast cancer and she refuses to take the pills, can she use them?

Prescription of Oral Contraceptives
Counseling Begin COC or POP at any time if reasonably certain is not pg If begun within 5 days of bleeding no extra protection If not within 5 days use back up for 7 days if on COC, and for 2 days if on POP Begin immediately post abortion Rapidly reversible, within 2-3 months conceptions are seen Medical history and physical examination Selection of a particular preparation User instructions Missed pill instructions No evidence that obese patients suffer decreased efficacy impact of hormonal contraceptives on lipoprotein metabolism may differ The impact of hormonal contraceptives for thromboembolism may differ More studies needed to assess mechanisms and methods of preventing vascular diseases

Establishing that a patient is protected by her contraception
Mode of action for contraceptive protection Molecular: P suppresses LH, E suppresses FSH Cellular: E increases intracellular P receptors Reproductive Organs: Endometrial atrophy, hostile cervical mucus Reproductive Processes WHO in last report said that it is not reliably known how accurately ultrasound findings, hormonal measurements or evaluation of the cervical mucus predict the risk of pregnancy during most contraceptive use 150 levo/30 EE fo 81 day showed 65% have inactive or atrophic endometrium after taking the regimen for a year 100 LNG/20 WW 7/8 had inactive endometrium after 9 cycles

Pharmacologic Actions of Progestin and Estrogen
Ovarian and pituitary inhibition Ovarian and pituitary inhibition Thickening of cervical mucus Thinning of/increase in cervical mucus Endometrial atrophy/transformation Pharmacologic Actions of Progestin and Estrogen Combination oral contraceptives have two components—a synthetic estrogen and a synthetic progestin. Both components act synergistically to inhibit pituitary and ovarian activity and, thereby, prevent ovulation, which is their primary contraceptive effect. Progestin also thickens cervical mucus and causes transformation and atrophy of the endometrium. To some extent, these actions are offset by estrogen, which thins and increases cervical mucous and causes the endometrium to proliferate. Together, the estrogen and progestin components provide cycle control. Endometrial proliferation Cycle control Cycle control

Progestins in Oral Contraceptives
19-Nortestosterone Spironolactone Drospirenone Estranes Gonanes Norethindrone Norethindrone acetate Ethynodiol diacetate Norethynodrel Lynestrenol* Levonorgestrel Norgestrel Desogestrel Norgestimate Gestodene* Progestins in Oral Contraceptives Combination oral contraceptives include an estrogen and one of eight available progestins. Estrogen and progestin act synergistically to inhibit ovulation, impair sperm motility, and prevent fertilization. The dose of progestin in combination oral contraceptives has, like estrogen, also decreased (from 10 mg to between 0.15 mg and 1 mg) over time. Most of the synthetic progestins used in combination oral contraceptives in the United States are derived from 19-nortestosterone (norethindrone, norethindrone acetate, ethynodiol diacetate, norethynodrel, norgestrel, levonorgestrel, norgestimate, desogestrel). Drospirenone is a unique progestin derived from spironolactone. The “newer” progestins are highly selective and possess minimal androgenic properties. These include norgestimate, desogestrel, and drospirenone. Reference: Sulak PJ. Contraceptive redesign: New progestins / new regimens. OBG Management. 2004;Suppl:3-8. *Not available in the United States. Adapted from Sulak PJ. OBG Management. 2004;Suppl:3-8.

Multiphasic vs Monophasic Preparations*
18 10 5 1.0 0.75 0.5 0.4 20 Norethindrone (mg) Endogenous progesterone (ng/mL) SLIDE 7 menses Multiphasic preparations were designed to provide estrogen and progestin levels that parallel natural hormonal levels throughout the menstrual cycle.4 However, progestin levels do not mimic natural progesterone levels during the follicular phase, which is negligible5 Monophasic preparations have the advantage of greater flexibility in use. Each tablet is identical, and 1 tablet can be substituted for another in the event that a tablet is lost Day 21 of the pill cycle is equivalent to day 28 of the menstrual cycle Monophasic Biphasic Triphasic Shortened pill-free interval Progestegin only containing pills Typical Use Issues 8/year Failure greater if pills are miss early in cycle Contraceptive Efficacy of all marketed pills are similar Benefits are identical in spite of package insert Day of pill cycle Monophasic (Ovcon 35) Multiphasic (Ortho Novum 7/7/7) Endogenous progesterone level * Ethinyl estradiol content is constant (35 µg) for both preparations. Adapted from Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 3rd ed. 1996:1416.

Available Formulations
Monophasic: consistent dose in each active pill Phasic Preparations: dosing of E/P varies through the cycle Biphasic Triphasic Shortened pill-free interval Progestogen only containing pills Greater percentage of cycles are ovulatory (>50%) Typical Use Issues 8/year Failure greater if pills are miss early in cycle Contraceptive Efficacy of all marketed pills are similar 0.3% failure perfect use about 8.0% failure typical use Benefits are identical in spite of package insert

Cardiovascular Impact of Risk Factors
Venous= VTE (DVT, PE) Arterial= Strokes and MI Obesity Pregnancy Malignancy Recent Surgery Smoking Diabetes Hypertension Obesity SLIDE 8

CV Mortality Risk with Smoking and OC Use
Oral contraceptive nonuser Oral contraceptive user Cases per 100,000 Woman-Years Cardiovascular Mortality Risk with Smoking and Combination Oral Contraceptive Use The older combination oral contraceptive pills contained greater amounts of estrogen and were associated with increased cardiovascular risk, including venous thromboembolism and stroke. The oral contraceptives available today contain low doses of estrogen and are associated with an increased cardiovascular risk only in specific patient populations. As shown in this bar graph, the factor that most adversely affects risk of cardiovascular mortality in oral contraceptive users is smoking, particularly in older women. The data also indicate that women over the age of 35 who do not smoke may use oral contraceptives without a dramatically increased risk of cardiovascular mortality. Reference: Sherif K. Benefits and risks of oral contraceptives. Am J Obstet Gynecol. 1999;180(Pt 2):S343-S348. No increase in risk for healthy, nonsmoking OC users 2 events/100,000 women age 40-44 Smoking is the key lifestyle risk factor 7.4% of OC users smoke Dose-related increase in MI risk with smoking in OC users Synergism between OC use and smoking increases risk The effects of estrogen on coagulation on the arterial side of the circulatory system can lead to myocardial infarction (MI) and stroke.3 MI and stroke are uncommon in young women, and the incidence is no higher in OC users than in nonusers unless they smoke3 or have other risk factors,3,4,7 such as hypertension, obesity, or diabetes4 The prevalence of smoking among American women aged 18 to 44 years who use OCs is 7.4%.8 OC use has a synergistic effect with smoking to increase the risk of MI,3 possibly as a result of decreased fibrinolytic activity.4 Smoking increases the risk of MI in a dose-related fashion in OC users.3,4 The risk of MI may be lower with third-generation OCs than with second-generation OCs9 Nonsmoker Smoker Nonsmoker Smoker Attributable Risk/100,000 User-Years 0.06 1.73 3.03 19.4 < 35 years of age ≥ 35 years of age Sherif K. Am J Obstet Gynecol. 1999;180(Pt 2):S343-S348.

Risks of Oral Contraceptives: Nonfatal VTE
Estimated Average Risk/ 100,000 Women/Year Risks of Oral Contraceptives: Nonfatal Venous Thromboembolism The estrogen component of combination oral contraceptives is known to impact the clotting system and to increase the risk of venous thromboembolism (VTE). The risk of nonfatal VTE among oral contraceptive (OC) users has been the subject of extensive research. In 1995, several studies of the VTE risk associated with low-dose OCs were analyzed by the United States Food and Drug Administration (FDA). The analysis included both older and more recent studies, whether published or unpublished. Based on the study results, the estimated annual risk of nonfatal VTE among oral contraceptive users was much lower than the risk posed by pregnancy. However, the FDA found that the newer progestin desogestrel was associated with a two-fold increase in the risk of venous blood clots when compared to the older progestin levonorgestrel: 4 cases/100,000 women/year among nonusers of oral contraceptives 10 to 15 cases/100,000 women/year among users of combination oral contraceptives containing levonorgestrel 20 to 30 cases/100,000 women/year among users of combination oral contraceptives containing desogestrel 60 cases/100,000 women for pregnant women A study reported by Jick et al. in 2006 was designed to obtain quantitative information on the risk of nonfatal VTE in women using OCs containing either norgestimate or desogestrel in comparison with women taking OCs containing levonorgestrel. A nested case-control study was designed to estimate relative risks of nonfatal VTE among 15- to 39-year-old current users of OCs containing norgestimate with 35 μg of ethinyl estradiol (EE), desogestrel with 30 μg of EE or levonorgestrel with 30 μg of EE, both monophasic and triphasic preparations, during the period January 2000 to March Cases were women with a well-documented VTE of uncertain origin that was diagnosed in current users of a study drug. Up to four controls were closely matched to each case by age and calendar time, and odds ratios (ORs) were calculated using conditional logistic regression comparing the risk of VTE among users of the three contraceptives. We also estimated and compared the incidence rates for all three OCs. The incidence rates of VTE were 30.6 (95% CI, 25.5–36.5), 53.5 (95% CI, 42.9–66.0) and 27.1 (95% CI, 21.1– 34.3) per 100,000 woman-years for users of norgestimate-, desogestrel- and levonorgestrel-containing OCs, respectively. The incidence rate ratios for norgestimate-containing OCs compared to levonorgestrel-containing OCs and desogestrel-containing OCs compared to levonorgestrel-containing OCs were 1.1 (95% CI, 0.8 –1.5) and 2.0 (95% CI, 1.4–2.7), respectively. The study investigators concluded that the risk of nonfatal VTE among users of desogestrel-containing OCs is significantly elevated compared to that of levonorgestrel-containing OCs. The risk of VTE in users of norgestimate-containing OCs was closely similar to that of users of levonorgestrel-containing OCs. References: Food and Drug Administration. Oral contraceptives and the risk of blood clots. FDA Talk Paper. Nov. 24, 1995. Jick SS, Kaye JA, Russmann S, Jick H. Risk of nonfatal venous thromboembolism with oral contraceptives containing norgestimate or desogestrel compared with oral contraceptives containing levonorgestrel. Contraception Jun;73(6): Epub 2006 Mar 29. The use of OCs is associated with approximately a 3- to 4-fold increased risk of VTE, which includes deep venous thrombosis (DVT) and pulmonary embolism (PE), compared with no OC use; this represents only one half the risk associated with pregnancy.3 The incidence of VTE is relatively low, with only 7.7 to 42.2 cases per 100,000 women who use OCs each year.4 The mortality rate from VTE is even lower (0.2 to 2.8 deaths per 100,000 OC users per year)4 Risk factors for VTE include obesity, smoking,1 surgery, immobilization, a mutation in clotting factor V known as the factor V Leiden mutation, and other inherited or acquired thrombophilias5 Smoking rates are declining slowly Prevalence of obesity is increasing 25% of women report no regular physical activity Most risks increase with age >50% of women over 45 have hypertension >50% of women over 55 have pathologic lipid levels Non-Oral Contraceptive Users Oral Contraceptive Users Pregnant Women Food and Drug Administration. FDA Talk Paper. Nov. 24, 1995.

Cardiovascular Impact of OCs
Venous Arterial No difference in risk between 2nd- and 3rd- generation progestins No difference in risk among low-dose OCs (20 µg to 35 µg) Increased clotting factors Estrogens increase HDL Progestins lower HDL High E/P ratio increases HDL Estrogen has a dilating effect on arterial wall SLIDE 8

Reproductive Tract Cancers
1.24 risk of breast cancer in OC users Existing cancers may have earlier development Protective effect against colon cancer Endometrial and ovarian cancer risk reduction is greater with increasing duration of use OVARIAN ENDOMETRIAL T Relative risk of cancer BREAST SLIDE 15 The risk of malignancy in various hormonally sensitive tissues, including breast, ovarian, and endometrial tissues, has been studied in OC users. Any suspected increase in risk of breast cancer has been highly controversial because of conflicting study results. A slight increase in risk of breast cancer during and within 10 years after discontinuing OC use has been reported,4 although the malignancies were less advanced at the time of diagnosis than those in OC nonusers (ie, diagnosis took place earlier in the course of the disease in OC users).4 Other analyses found no overall increase in risk of breast cancer for OC users compared with nonusers10 OC use protects against endometrial and ovarian cancers.4 The reduction in risk for both types of cancer increases with increasing duration of use4,11 Relative Risk of Breast Cancer in Oral Contraceptive Users According to Estrogen or Progestin Content 4575 women with breast cancer and 4682 controls between the ages of 35 and 64 were interviewed for a population-based, case-control study to determine the risk of breast cancer among former and current users of oral contraceptives (OCs). Conditional logistic regression was used to calculate odds ratios as estimates of the relative risk of breast cancer. The reference group comprised women who had never used OCs (n=1032 with breast cancer, n=980 without breast cancer). Current or former use of a high-estrogen dose defined as 50 mg or more of ethinyl estradiol or 75 mg or more of mestranol resulted in an odds ratio of 0.8 (95% CI ). Current or former use of a low-estrogen dose defined as less than 50 mg of ethinyl estradiol or less than 75 mg of mestranol resulted in an odds ratio of 0.9 (95% CI ). Odds ratios and 95% CIs are plotted on the chart for current or former use of progestins. The group titled desogestrel or norgestimate, sometimes referred to as “new” or “third generation” progestins, included 1 former user of gestodene. Any OC use, regardless of estrogen or progestin content and regardless of duration of use, did not result in an increased RR of breast cancer. The authors concluded that among women from 35 to 64 years of age, current or former OC use was not associated with a significantly increased risk of breast cancer. Duration of OC use

Oral Contraceptives and the Risk of Breast Cancer
Results of a large epidemiologic study suggest that oral contraceptives do not cause breast cancer Breast cancer risk in women who have not taken oral contraceptives for ≥10 years is the same as those who have never used them There is a slightly increased risk of diagnosis in current users of oral contraceptives and in those who stopped taking them ≤10 years ago Tumors are more likely to be localized in oral contraceptive users than in nonusers Oral Contraceptives and the Risk of Breast Cancer The Collaborative Group on Hormonal Factors in Breast Cancer conducted an analysis of data collected from 54 epidemiologic studies of more than 53,000 women with breast cancer and more than 100,000 without breast cancer. These investigators found that women who had stopped taking oral contraceptives 10 or more years before the study had no excess risk of being diagnosed with breast cancer (relative risk [RR] at 10 years = 1.01, 95% confidence interval [CI], ). The investigators also found that within one to four years after oral contraceptives were discontinued, the risk of being diagnosed with breast cancer was 1.16 (95% CI, ), and within five to nine years after discontinuation, the risk of being diagnosed with breast cancer was 1.07 (95% CI, ). Current oral contraceptive users had a very small increased risk of being diagnosed with breast cancer (RR =1.24, 95% CI, ). The analysis also found that women with breast cancer who used oral contraceptives were more likely to have localized tumors; these women may have received more frequent breast cancer screening. Data indicate that oral contraceptives do not increase the risk of breast cancer in women who have a family history (mother or sister) of breast cancer or in women who have benign breast disease. Women who have breast cancer should not use oral contraceptives. References: Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormonal contraceptives: collaborative reanalysis of individual data on 53,297 women with breast cancer and 100,239 women without breast cancer from 54 epidemiological studies. Lancet. 1996;347: Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormonal contraceptives: further results. Contraception. 1996;54(Suppl):1S-106S. Schlesselman JJ. Oral contraceptives and breast cancer. Am J Obstet Gynecol. 1990;163: Murray PP, Stadel BV, Schlesselman JJ. Oral contraceptive use in women with a family history of breast cancer. Obstet Gynecol. 1989;73: Collaborative Group on Hormonal Factors in Breast Cancer. Lancet. 1996;347: ; Collaborative Group on Hormonal Factors in Breast Cancer. Contraception. 1996;54:1S-106S.

Acne and Androgen Metabolism
Total testosterone Sex hormone-binding globulin Free testosterone 5-reductase AR Dihydrotestosterone Acne and Androgen Metabolism Acne develops in part because of excessive secretion of sebum by the sebaceous glands. As shown in this slide, sebum production is stimulated by dihydrotestosterone, which is derived from free testosterone in the presence of 5-reductase. The factors determining the level of free testosterone are total testosterone and sex hormone-binding globulin (SHBG). An increase in total testosterone levels or a decrease in SHBG levels (which binds testosterone) causes free testosterone levels to rise. Testosterone is produced by the adrenal glands and, in females, by the ovaries while SHBG is produced by the liver. Women who have acne also may have elevated serum levels of total testosterone, free testosterone, dehydroepiandrosterone (DHEAS), 3-androstanediol glucuronide (3-diol G), and androstenedione; excess dihydrotestosterone (DHT) in the skin; and low levels of sex hormone-binding globulin (SHBG). Consequently, treatments that lower circulating and local androgen levels are likely to be effective acne treatments, in part by lowering sebum production. The use of an androgen receptor blocker for the treatment of acne supports this idea. References: Azziz R, Gay F. The treatment of hyperandrogenism with oral contraceptives. Semin Reproduct Endocrinol. 1989;7: Imperato-McGinley J, Gautier T et al. The androgen control of sebum production. Studies of subjects with dihydrotestosterone deficiency and complete androgen insensitivity. J Clin Endocrinol Metab. Murphy AA, Cropp CS, Smith BS, Burkman RT, Zacur HA. Effect of low-dose oral contraceptive on gonadotropins, androgens, and sex hormone binding globulin in nonhirsute women. Fertil Steril. 1990;53: Pye RJ, Meyrick G, Pye MJ, Burton JL. Effect of oral contraceptives on sebum excretion rate. Br Med J. 1977;2: Lucky AW, McGuire J, Rosenfield RL, Lucky PA, Rich BH. Plasma androgens in women with acne vulgaris. J Invest Dermatol. 1983;81: Darley CR, Kirby JD, Besser GM, Munro DD, Edwards CRW, Rees LH. Circulating testosterone, sex hormone binding globulin and prolactin in women with late onset or persistent acne vulgaris. Br J Dermatol. 1982;106: Cibula D, Hill M, Vohradnikova O, Kuzel D, Fanta M, Zivny J. The role of androgens in determining acne severity in adult women. Br J Dermatol. 2000;143: Schiavone FE, Rietschel RL, Sgoutas D, Harris R. Elevated free testosterone levels in women with acne. Arch Dermatol. 1983;119: Lemay A, Dewailly SD, Grenier R, Huard J. Attenuation of mild hyperandrogenic activity in postpubertal acne by a triphasic oral contraceptive containing low doses of ethinyl estradiol and d,l-norgestrel. J Clin Endocrinol Metab. 1990;71: Sansone G, Reisner RM. Differential rates of conversion of testosterone to dihydrotestosterone in acne and in normal skin: a possible pathogenic factor in acne. J Invest Dermatol. 1971;56: Shaw JC. Antiandrogen and hormonal treatment of acne. Dermatol Clin. 1996;14: How Oral Contraceptives Improve Acne The estrogen component of combined oral contraceptives improves acne by decreasing production of androgens (testosterone, free testosterone, and dihydrotestosterone) both in the ovaries and in the adrenal glands. Production of 5-reductase activity, the enzyme that converts free testosterone into dihydrotestosterone in target tissues such as the skin and hair follicles, is also decreased. The estrogen component also increases sex hormone-binding globulin, leading to decreased levels of free testosterone and suppression of androgen production. Progestin-only oral contraceptives are not effective in treating acne and result in worsened acne. Although some progestins possess antiandrogenic properties, the estrogen component is mainly responsible for the ability of oral contraceptives to improve acne. In summary, combined oral contraceptives improve acne by reducing the level of free testosterone and, in turn, the androgenic stimulation of the sebaceous gland. van der Vange N, Blankenstein MA, Kloosterboer HJ, Haspels AA, Thijssen JHH. Effects of seven low-dose combined oral contraceptives on sex hormone binding globulin, corticosteroid binding globulin, and total and free testosterone. Contraception. 1990;41: Cassidenti DL, Paulson RJ, Serafini P, Stanczyk FZ, Lobo RA. Effects of sex steroids on skin 5a-reductase activity in vitro. Obstet Gynecol. 1991;78: Progestins are derived from testosterone Can bind to the androgen receptor All OC s increase SHBG Progestins have adverse effects on carbohydrate and lipid metabolism Clinically, a progestin’s androgenicity is a very small issue Small amounts, inhibit ovulation ug levonorgestrel Very large amounts, required for increase in organ weight by rat assay 700-21,000 ug levonorgestrel Androgenicity of a progestin is not expressed DRSP is anti-mineralocorticoid and antiandrogenic Sebum production AR = androgen receptor within the sebaceous gland Azziz R, et al. Semin Reproduct Endocrinol. 1989;7: ; Imperato-McGinley J, et al. J Clin Endrocrinol Metab. 1993;76: ; Murphy AA, et al. Fertil Steril. 1990; 53:35-39; Pye RJ, et al. Br Med J. 1977;2:

Higher Bone Density More Likely in OC Users
20 40 60 80 100 OC users Non-OC users % Women Higher Bone Density More Likely in OC Users This study* showed that women who have used OCs were more likely to have high bone mineral density (BMD) levels. OC use was shown to be protective against low BMD (odds ratio = 0.35; 95% confidence interval, 0.23 to 0.53). A smaller proportion of patients who had used OCs were in the lowest quartile† of bone mass compared to those who had never used OCs. Significantly more women with a history of OC use were in the higher levels (quartiles) of BMD compared to women who had never used the pill (P<.0001). * Cross-sectional, retrospective, epidemiologic study of approximately 2,300 women (76% postmenopausal). Study results confirmed by multivariate analyses. † Quartiles were used in this analysis because BMD measurement techniques were not standardized across centers, and actual values for BMD could not be directly combined for analyses. Reference: Kleerekoper M, Brienza RS, Schultz LR, et al. Oral contraceptive use may protect against low bone mass. Henry Ford Hospital Osteoporosis Cooperative Research Group. Arch Intern Med. 1991;151: POSTED: August 29, REVIEWED: August 29, 2001 1 2 3 4 (Low) (High) Bone Mineral Density Quartile Kleerekoper M et al. Arch Intern Med. 1991;151: Slide Source: ContraceptionOnline

Noncontraceptive Benefits of Oral Contraceptives
BENEFITS DUE TO CONTINUOUS PROGESTIN Less endometrial cancer Less benign breast disease 50% reduction in breast tumors Fewer uterine fibroids Regular uterine bleeding Less amount uterine bleeding less anemia less salpingitis 50% reduction in PID Less cyclic mood changes (PMS) BENEFITS DUE TO INHIBITION OF OVULATION Less ovarian cancer Less ectopic pregnancies Less functional ovarian cysts Suppression better with 35 mcg EE Less dysmenorrhea OTHER BENEFITS Less acne and hirsutism Less rheumatoid arthritis Increased bone density

Discontinuation of Oral Contraceptives
Irregular Bleeding Nausea Weight Gain Mood Changes Breast Tenderness Headaches % Discontinuing Side Effects Cited for Discontinuation of Oral Contraceptives Among the side effects that women cite as their reason for discontinuing oral contraceptives, the most common is irregular bleeding (12%). Other side effects cited as reasons for discontinuation include nausea, weight gain, mood changes, breast tenderness, and headaches. These nuisance side effects typically resolve after three months. Consequently, women should be counseled about them and should be encouraged to use an oral contraceptive for at least three cycles to allow the side effects to abate. Women should also understand that the rate of side effects is increased substantially by inconsistent use of oral contraceptives. Tolerability issues are especially frequent in women who are beginning an oral contraceptive regimen, which contributes to a higher discontinuation rate in this group. Reference: Rosenberg MJ, Waugh MS. Oral contraceptive discontinuation: a prospective evaluation of frequency and reasons. Am J Obstet Gynecol. 1998;179: Rosenberg MJ, et al. Am J Obstet Gynecol. 1998;179:

Shortened Hormone-Free Intervals
Brand Name Estrogen Dose Progestin Dose Regimen Seasonale® 30 µg EE 150 µg levonorgestrel 84/7 SeasoniqueTM 84/7* *7 days 10 µg EE Yaz 20 µg EE 3 mg drospirenone 24/4 Loestrin 24 Fe 1 mg norethindrone acetate 24/4* *4 days of iron Lybrel 90 µg levonorgestrel 365 days (non-cyclic daily dosing) Approved Regimens That Shorten the Hormone-Free Interval Since the standard 21/7 oral contraceptive regimen is associated with hormone-withdrawal symptoms, several extended-cycle regimens have been investigated and approved for use in the United States. These include the 84/7 regimens of Seasonale® and Seasonique™ (products trademarked by Duramed Pharmaceuticals, Inc.). Both regimens include 84 days of active pills (30 µg ethinyl estradiol/150 µg levonorgestrel); however, Seasonale includes seven days of hormone-free pills while Seasonique includes seven days of 10 µg ethinyl estradiol. Seasonique may be an option for women who experience bleeding/spotting during the use of an extended-cycle regimen. Two 24/4 regimens have been approved to decrease the number of bleeding days a woman experiences per month. Yaz (Berlex, Inc.) includes 24 days of 20 µg ethinyl estradiol/3 mg drospirenone followed by 4 days of hormone-free pills. Yaz is also approved for treating the emotional and physical symptoms of premenstrual dysphoric disorder. Loestrin 24 Fe (Warner-Chilcott, Inc.) includes 24 days of 20 µg ethinyl estradiol/1 mg norethindrone acetate followed by 4 days of an iron supplement. A low-dose estrogen/progestin formulation that is used continuously, 365 days per year has also been approved. Lybrel (Wyeth) is a noncyclic oral contraceptive containing a daily dose of 20 mcg. ethinyl estradiol/90 mcg. levonorgestrel. For information of using these regimens for suppressing menstruation, see the slide presentation, Menstrual Suppression Using Contraceptives in the Contraception Online Slide Library. Endometrium does not ‘build up’ Continuous pill use amenorrhea or very infrequent bleeding 68% after 3 months 88% after 1 year Withdrawal bleeds every 3 months will probably produce best combination of amenorrhea and predictable bleeding 30 mcg of ethinyl estradiol and 150 mcg of levonorgesterel 60% of Seasonal group discontinued and 71% of the conventional regimens discontinued with 7.7% of Seasonale patients reporting unacceptable bleeding verses 1.8% in conventional regimen Pregnancy was 0.60 for Seasonal and 1.78 for conventional group and body weight was not a factor EE= ethinyl estradiol

Breakthrough Bleeding and Spotting and Extended Regimen
Median Number of Breakthrough Bleeding/Spotting Days/Cycle Breakthrough Bleeding and Spotting Decrease Over Time with an Extended-Cycle (84/7) Oral Contraceptive Regimen To alleviate the symptoms women experience during the hormone-free interval of traditional 21/7 oral contraceptive regimens, extended-cycle regimens have been investigated and recently approved for use by the United States Food and Drug Administration. Anderson and Hait conducted a parallel, randomized, multicenter, open-label trial of an extended-cycle (91-day) oral contraceptive regimen. A total of 682 women between the ages of 18 and 40 years were randomized to receive an oral contraceptive regimen consisting of either 1) 4 extended 91-day (84/7) cycles of 30 µg ethinyl estradiol/150 µg levonorgestrel, or 2) 13 conventional 28-day (21/7) cycles of 30 µg ethinyl estradiol/150 µg levonorgestrel. Although the women who received the extended-cycle regimen reported a greater frequency of breakthrough bleeding and spotting than did the women who received the conventional regimen, the median number of intermenstrual spotting and bleeding days/cycle decreased over time. References: Anderson FD, Hait H. A multicenter, randomized study of an extended cycle oral contraceptive. Contraception. 2003;68:89-96. Anderson FD, Gibbons W, Portman D. Safety and efficacy of an extended-regimen oral contraceptive utilizing continuous low-dose ethinyl estradiol. Contraception. 2006;73: Cycle Day 1-84 92-175 *30 µg ethinyl estradiol/150 µg levonorgestrel. Anderson FD, Hait H. Contraception. 2003;68:89-96.

Vaginal Ring: NuvaRing
NuvaRing releases 15 g of ethinyl estradiol and 120 g of etonogestrel daily Worn for 3 out of 4 weeks Self insertion and removal it is about 2.1 inches in diameter Pregnancy rate 0.65 per 100 woman–years If removed for >3hrs use back up method for 7 days Vaginal Ring: NuvaRing The etonogestrel/ethinyl estradiol (EE) vaginal ring is a flexible, soft, transparent ring with an outer diameter of 54 mm and a cross section of 4 mm. The vaginal ring is a new, highly effective contraceptive method recently approved by the FDA. The vaginal ring releases 120 µg of the progestin etonogestrel, formerly 3-keto-desogestrel, and 15 µg of the estrogen ethinyl estradiol, per day. It can be easily inserted and removed by the woman herself and is intended to be used for one cycle consisting of 3 weeks of continuous ring use and a 1-week ring-free period. In a study by Roumen et al, a total of six pregnancies were reported during treatment, giving it a Pearl Index of 0.65. Reference: Roumen FJ, Apter D, Mulders TM, Dieben TO. Efficacy, tolerability and acceptability of a novel contraceptive vaginal ring releasing etonogestrel and ethinyl oestradiol. Hum Reprod. 2001;16(3): POSTED: September 25, 2002 REVIEWED: September 25, 2002 Roumen FJ, et al. Hum Reprod. 2001;16:

Vaginal Contraceptive Ring: Administration
If Ring Is removed If under three hours reinsert If over three hours reinsert and use 1 week of back up Only 2.6% of women report ring expulsion 54 mm 4 mm Vaginal Contraceptive Ring: Administration The vaginal contraceptive ring delivers very low doses of ethinyl estradiol and etonogestrel while it is inserted in the vagina for a 3 week period. It is discarded and a new ring is inserted 1 week later. The sex hormones are delivered continuously while the ring is in the vagina through the flexible transparent ethylene vinyl acetate copolymer. Reference: Timmer CJ, Mulders TM. Pharmacokinetics of etonogestrel and ethinylestradiol released from a combined contraceptive vaginal ring. Clin Pharmacokinet 2000; 39 (3):

NuvaRing® Compared to OC: Intended Bleeding Pattern
COC Incidence of intended bleeding pattern (%) ** ** * * * NuvaRing® Compared to OC: Intended Bleeding Pattern A total of 247 women began this combined study, 121 with NuvaRing® and 126 with the 30 μg EE/150 μg LNG. With NuvaRing®, the incidence of the intended bleeding pattern was high in all evaluable intention-to-treat cycles. The values ranged from 65.3% to 68.4%. Levels were considerably lower with the COC group, ranging from 28.4% to 46.8%. A women was considered to have the intended bleeding pattern if she did not have irregular, late, or early withdrawal bleeding. Reference: Bjarnadottir RI, Tuppurainen M, Killick SR. Comparison of cycle control with a combined contraceptive vaginal ring and oral levonorgestrel/ethinyl estradiol. Am J Obstet Gynecol 2002; 186 (3): *P<0.01 **P<0.0001 1 2 3 4 5 Cycle Bjarnadottir RI, et al. Am J Obstet Gynecol. 2002;186: Copyright ©2002, Mosby Inc.

Contraceptive Patch: Ortho Evra
Patch contains 6 mg norelgestromin and mg ethinyl estradiol Delivers continuous systemic doses of hormones µg norelgestromin (NGMN) 20-25 µg ethinyl estradiol (EE) Direct comparisons to oral contraceptive delivery doses cannot be made but compliance enhanced If patch is removed for >24 hours apply a new patch and use back up for 7 days and the day of the week for patch change is now the day you found the patch off Per day Contraceptive Patch: Ortho Evra Assuming a model of women ages 15 to 50 in average health in a long-term mutually monogamous, heterosexual relationship Patch use results in a savings of $249 and 0.03 pregnancies per women over 2 years compared to COC use (even with generic pill pricing structure) The transdermal contraceptive patch is beige in color, very thin, and pliable. The patch can be applied to the buttocks, upper outer arm, lower abdomen (shown), or upper torso, but not on the breasts. The patch is comprised of three layers – a backing layer, a middle layer, and a release liner – referred to as a matrix system. Due to its unique delivery mechanism, each transdermal contraceptive patch worn delivers continuous doses of estrogen and progestin into the bloodstream. The progestin is norelgestromin – the active metabolite of norgestimate, commonly found in popular oral contraceptives (OCs). The estrogen is ethinyl estradiol, which is used in all OC formulations. Doses cannot be directly equated to an OC since the pharmacokinetic profile is so different. References: Audet MC, Moreau M, Koltun WD, Waldbaum AS, Shangold G, Fisher AC, Creasy GW. Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial. JAMA. 2001;285(18): Smallwood GH, Meador ML, Lenihan JP, Shangold GA, Fisher AC, Creasy GW. Efficacy and safety of a transdermal contraceptive system. Obstet Gynecol. 2001;98(5 Pt 1): Abrams LS, Skee D, Natarajan J, Wong FA. Pharmacokinetic overview of Ortho Evra/Evra. Fertil Steril Feb;77(2 Suppl 2):S3-12. POSTED: September 25, 2002 REVIEWED: September 25, 2002

Transdermal Patch: 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 Transdermal Contraceptive Patch: Disadvantages The Ortho Evra® contraceptive patch has important disadvantages that may result in user discontinuation. The patch may produce application site reactions, its efficacy is decreased in women weighing more than 198 pounds, there is a likelihood of a higher rate of dysmenorrhea and of breast pain during the first two cycles, and privacy may be compromised due to the patch’s visibility. Finally, the patch does not provide protection against sexually transmitted infections or HIV. References: Zieman M, Guillebaud J, Weisberg E, Shangold GA, Fisher AC, Creasy GW. Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: the analysis of pooled data. Fertil Steril. 2002;77(Suppl 2):S13-S18. Zieman M, et al. Fertil Steril. 2002;77(Suppl 2):S13-S18.

Patch: Patient Counseling
Application: 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 Transdermal Contraceptive Patch: Patient Counseling on Usage and Disposal Each transdermal patch should be applied to a unique area, which could be near the site of the last patch. The patch should be applied to the buttocks, abdomen, upper outer arm, or upper torso – places where it won’t be rubbed by clothing. It should not be applied to red, irritated or cut skin or to the breasts. Users may bathe and swim as usual but should not apply oils, creams, or cosmetics on or around the patch area. Unused patches should be stored at room temperature. Used patches should not be flushed into the water system; they should be folded in half and discarded in the trash. The contraceptive efficacy of the patch may be altered if the patch is cut or damaged. Cartons containing a single patch are available with a prescription in the event that a patch is inadvertently lost or damaged. Reference: Ortho Evra® [revised prescribing information]. Raritan, NJ: Ortho-McNeil Pharmaceutical, Inc; September 2006.

Next 28-Day Cycle (Days 29-56)
Patch: Managing 28-Day Cycle (Days 1-28) Next 28-Day Cycle (Days 29-56) Patch #1 Days 1-7 Patch #2 Days 8-15 Patch #3 Days 16-21 No Patch Patch #1 This patch was not removed: Remove immediately Start cycle on day 29 Patch application is 1 to 2 days late: Apply new patch immediately; Make this the new “patch change day” No backup protection is required Patch application is >2 days late: Immediately start new 21-day application cycle Use backup protection for 7 days Consider emergency contraception Transdermal Contraceptive Patch: Managing Missed or Late Applications These instructions summarize the prescribing information for the Ortho Evra® transdermal contraceptive patch as approved for use in the United States. Because the hormones in the patch take 48 hours to reach contraceptive efficacy, failure to use the patch as instructed puts the patient at risk for an unintended pregnancy. If a patch was not applied at the start of the patch cycle – day 1 of the first cycle or day 29 of the second cycle – the patch should be applied immediately and a backup nonhormonal contraceptive should be used for seven days. The day the patient applies this patch becomes her “patch change day” for all subsequent patch changes. If she has had or does not remember if she has had unprotected intercourse during the time she forgot to apply a new patch, rule out pregnancy or consider emergency contraception. If the patient does not apply the second (day 8) or the third (day 15) patch on the “patch change day” and it is now one to two days after that day, instruct her to apply a new patch immediately and make this day her “patch change day.” If the change to a new patch is more than two days late, instruct the patient to start a new 21-day cycle immediately and use a backup nonhormonal contraceptive for seven days. The first day she applies this patch becomes her “patch change day” for all subsequent patch changes. If the patient has had or does not remember if she has had unprotected intercourse during the time she forgot to apply a new patch, rule out pregnancy or consider emergency contraception. If the third patch is not changed between days 22 and 28, instruct the patient to remove the patch immediately. A backup nonhormonal contraceptive is not needed because days 22–28 are the “patch-free” week. The new cycle will start with a new patch on day 29, the expected “patch change day.” Cartons containing a single patch are available with a prescription in the event that a patch is inadvertently lost or damaged. Reference: Ortho Evra® [revised prescribing information]. Raritan, NJ: Ortho-McNeil Pharmaceutical, Inc; September 2006. This patch was not applied: Apply a new patch immediately; this is the new “patch change day” Use backup protection for 7 days Consider emergency contraception

Breakthrough Bleeding and/or Spotting:Patch Versus Pill
Percentage of patients Cycle Contraceptive Patch Oral Contraceptive Breakthrough Bleeding and/or Spotting: The Contraceptive Patch (Ortho Evra®) Versus an Oral Contraceptive (Triphasil®) Audet et al. designed a randomized, active control clinical trial to compare the Ortho Evra® transdermal contraceptive patch with Triphasil®, an established oral contraceptive, with regard to efficacy, safety, cycle control, and patient compliance. A total of 1,417 women between the ages of 18 to 45 years were randomized to use the patch (n=812) or the oral contraceptive (n=605) for 6 or 13 cycles. The percentage of patients who experienced breakthrough bleeding and/or spotting was generally numerically higher among the group using the transdermal contraceptive patch than among the group using the oral contraceptive. The differences between the two treatment groups were statistically significant for only cycles 1 and 2 (the P values were not published). Although the percentage of patients who experienced breakthrough bleeding that required more than one pad or tampon per day was numerically lower among the patch group than among the oral contraceptive group, there were no statistically significant differences between the two groups during any of the study cycles. Reference: Audet MC, Moreau M, Koltun WD, et al. for the ORTHO EVRA/EVRA 004 Study Group. Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial. JAMA. 2001;285: Audet MC, et al. JAMA. 2001;285: ©2001, American Medical Association.

Estrogen Exposure: Patch, OCs, Ring
Ring (15 µg EE/day) Patch (20 µg EE/day) OC (30 µg EE/day) * * *P<0.05 vs patch and ring *P<0.05 vs ring and OC †P<0.05 vs ring † Estrogen Exposure: Contraceptive Patch Compared to OCs and the Vaginal Ring In an open-label, randomized parallel group trial conducted by van den Heuvel et al., the pharmacokinetics of ethinyl estradiol (EE) from a vaginal ring (15 μg EE/day), the Ortho Evra® transdermal patch (20 μg EE/day), and a combined oral contraceptive (30 μg EE/150 μg levonorgestrel/day) were compared in 24 women between the ages of 18 and 40 years. After two to eight weeks of synchronization by treatment with a combined oral contraceptive, the subjects were randomized to 231 days of treatment with one of the three contraceptives being compared. Analysis of the area under the EE concentration-versus-time curve (AUC) during 21 days of treatment showed that exposure to EE was highest in the patch group and that systemic exposure to estrogen was 60% higher with the patch than with the oral contraceptive (P<0.05 for both comparisons). The highest mean peak concentration (Cmax) was seen in the contraceptive pill group, which was 4.5 times higher than in the vaginal ring group and 1.6 times higher than in the patch group (P<0.05 for both comparisons). The mean Cmax for the patch was 2.8 times greater than that of the vaginal ring (P<0.05). In 2005, the U.S. Food and Drug Administration approved updated labeling information for the Ortho Evra patch to alert healthcare providers and patients about the increased levels of estrogen that users of the patch are exposed to in comparison to oral contraceptive users. Reference: van den Heuvel MW, van Bragt AJ, Alnabawy AK, Kaptein MC. Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive. Contraception. 2005;72: AUC 0-21 (ng.h/mL) Cmax (pg/mL) OCs = oral contraceptive; EE = ethinyl estradiol van den Heuvel, et al. Contraception. 2005;72:

Transdermal Contraceptive Patch:Risk for VTE Events*
Relevant Studies Odds Ratio (95% Confidence Interval) Jick SS, et al., 2006 0.9 (0.5–1.6) Cole JA, et al., 2007 2.4 (1.1–5.5) Transdermal Contraceptive Patch: Risk for Venous Thromboembolic Events As with other methods of hormonal contraception, some users of the Ortho Evra® transdermal patch have had venous thromboembolic events. Although it has been hypothesized that the patch confers an increased risk of these events because it contains a greater amount of estradiol than other hormonal contraceptive methods, studies of transdermal patch usage and risk of venous thromboembolic events have given conflicting results. Two case-control studies used electronic healthcare claims data to compare the risk of venous thromboembolic events in women between the ages of 15 and 44 years who used either the transdermal patch or a norgestimate-containing oral contraceptive. In the study by Jick et al., the overall incidence rates of these events were 52.8 per 100,000 women-years for users of the patch and 41.8 per 100,000 women-years for users of the oral contraceptive. The odds ratio for current users of the patch was 0.9 (95% confidence interval [CI] ). In the study by Cole et al., which also included a chart review, the incidence rate of venous thromboembolic events was 40.8 per 100,000 women-years for current users of the patch as compared to 18.3 per 100,000 women-years for users of the oral contraceptive. Overall, there was a two-fold increase in the risk of venous thromboembolic events among users of the patch when compared with users of the oral contraceptive (OR 2.4, 95% CI ). Differences in study design may explain the conflicting results of these studies. For example, the study by Jick et al. relied on insurance claims to determine outcomes of venous thromboembolic events rather than on using a chart review as Cole et al. did. There were also differences in the patient selection processes, which may have influenced the outcomes. The study by Jick et al. included only those patients who had just begun using a study medication. As such, prior users of norgestimate-containing oral contraceptives were excluded from the norgestimate group but were permitted in the transdermal patch group. These participants with past hormonal contraceptive experience may have attenuated the incidence of venous thromboembolic events in the transdermal group since the risk of these events is greatest in the early phases of use. In contrast, participants in the study by Cole et al. were included if they had had at least one dispensing of a study medication. In 2006, the U.S. Food and Drug Administration (FDA) approved updated labeling information for the Ortho Evra patch to alert healthcare providers and patients of these epidemiologic studies. The FDA also recommend that women with risk factors for venous thromboembolic events discuss the use of the Ortho Evra patch with their healthcare provider because it may be associated with an increased risk of these events in some women. Women should be counseled about the risk of venous thromboembolic events that is associated with the use of any combined contraceptive product, and women who have risk factors for these events should consider using nonhormonal contraceptive methods. Women who are immobilized due to surgery or injury should discontinue the Ortho Evra patch because of the associated risk for venous thromboembolic events. References: Jick SS, Kaye JA, Russmann S, Jick H. Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception. 2006;73: Cole JA, Norman H, Doherty M, Walker AM. Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users. Obstet Gynecol. 2007;109: Ortho Evra® [revised prescribing information]. Raritan, NJ: Ortho-McNeil Pharmaceutical, Inc; September 2006. *Women should be counseled that all combined contraceptive products increase the risk of venous thromboembolic events; use of these products should be discontinued if a patient becomes immobilized. Jick SS, et al. Contraception. 2006;73: ; Cole JA, et al. Obstet Gynecol. 2007;109:

What is Emergency Contraception?
“A therapy for women who have had unprotected sexual intercourse, including sexual assault.” –ACOG Not just the “morning-after pill” – hormonal EC can be given up to 72 hours after unprotected intercourse PREVEN, Plan B upto 120 hours post IC but effective is reduced 150 mg of Levo Copper IUD (up to 5 days after ovulation) Mifepristone (off label, up to 120 hours after unprotected sex) No contraceptive use for IC or Condom slipped, broke, or leaked, diaphragm/cervical cap was inserted incorrectly, dislodged, was removed too early, or torn. Missed 2 or more of the first combined OCs, 4 or more pills during the 2nd week (pills 8-14), or 1 progestin only pill. “Morning After” an unfortunate misnomer, effective within 72 hours of unprotected sex, in some studies up to 5 days 12 different OCs are declared by FDA to be safe and effective for EC use, Plan B has emerged as most effective (Leveo 0.75 mg) No contraindications but no studies in special populations consider IUD or the 20 pill Ovrette (0.075 mg norgesterel) if OC are contraindicated Slide Title: What is Emergency Contraception? Talk Title: Emergency Contraception: An Update Related Terms: emergency contraception/morning-after pill/PREVEN/Plan B/copper IUD/mifepristone/unprotected intercourse Notes: Emergency contraception, as defined by the American College of Obstetricians and Gynecologists (ACOG), is “A therapy for women who have had unprotected sexual intercourse, including sexual assault.” Although known for decades as the “morning-after pill,” hormonal contraception can be given up to 72 hours after unprotected intercourse, while the copper IUD can be placed in the uterus up to 5 days after the earliest estimated date of ovulation. References: 1. ACOG Practice Bulletin. Emergency oral contraception. Int J Gynecol Obstet. 2002;78(25): 2. LaValleur J. Emergency contraception. Obstet Gynecol Clin North Am. 2000;27(4): ACOG Practice Bulletin. Int J Gynecol Obstet. 2002;78: LaValleur J. Obstet Gynecol Clin North Am. 2000;27(4):

EPC Effectiveness If unprotected sex during wk 2 or 3
8% will become pregnant if not treated 2% will be pregnant following use of combined ECP (equivalent to a 75% reduction) 1% will become pregnant if use emergency POP (equivalent to an 88% reduction) 0.1% will become pregnant following emergency copper IUD insertion (99% reduction) Even late in the cycle a % chance of pregnancy is possible There is an algorithm to predict when menses will come 1.50 mg Levonorgesterel in single does is the best It is not really known what the minimum effective dose is This is least likely to cause N and V, no pretreatment to prevent N and V is necessary If someone vomits within 2 hours of her pills she should take them again

Long-Acting Steroid Contraceptive Options

Contraceptive Cases A 22 year old healthy patient wants to use DMPA but she cannot get in to the office on her menstrual week as that’s the week she travels, can she start the shots any other time? A 33 year old breast feeding mom wants DMPA before leaving the hospital after her delivery, is this permissible? A woman has been on DMPA for greater than 2 years, should she continue? Should she get a Bone Density test? DMPA: use 7 days back up, Norplant: use 3

Depot-Medroxyprogesterone Acetate
Depo-Provera mg of DMPA via deep intramuscular injection in the gluteal or deltoid muscle Depo-subQ Provera mg of DMPA via subcutaneous injection into the anterior thigh or abdomen Mechanism of action:Duration of protection: 3 m(13 wks) Inhibits ovulation Suppresses levels of follicle-stimulating hormone and luteinizing hormone Eliminates surges in luteinizing hormone Thickens cervical mucus Prevents sperm penetration Reduces sperm transport in the fallopian tubes Atrophies the endometrium Injectable Contraceptives: Depot-Medroxyprogesterone Acetate There are two progestin-only injectable contraceptives approved by the United States Food and Drug Administration (Depo-Provera and Depo-subQ Provera 104). They slowly release depot-medroxyprogesterone acetate (DMPA) and are effective for approximately 13 weeks. Depo-Provera (150-mg DMPA) is delivered via an intramuscular injection in the gluteal or deltoid muscle, whereas Depo-subQ Provera 104 (104-mg DMPA-SC) is injected subcutaneously into the anterior thigh or abdomen. These methods are appropriate for those who cannot use estrogen-containing contraceptives. Depo-subQ Provera 104 is also approved by the United States Food and Drug Administration to treat pain associated with endometriosis. Injectable Depot-Medroxyprogesterone Acetate: Mechanisms of Action As with other progestin-only contraceptives, injectable depot-medroxyprogesterone acetate (DMPA) is believed to exert its effects via several mechanisms of action. First, injectable DMPA inhibits ovulation by suppressing both follicle-stimulating hormone and luteinizing hormone and by eliminating surges in luteinizing hormone. Second, thickening of the cervical mucus inhibits sperm transport and penetration. Third, atrophy of the endometrium results in decreased receptivity to the blastocyst. Reference: Hatcher RA. Depo-Provera injections, implants, and progestin-only pills (minipills). In: Hatcher RA, Trussell JA, Stewart F, Nelson AL, Cates W Jr, Guest F, Kowal D, eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media, Inc.; 2004: DMPA = depot-medroxyprogesterone acetate Slide Source: Contraception Online

Injectables: Failure Rate Among Typical Users
8% 8% 8% Percentage of Women Experiencing an Unintended Pregnancy 3% Injectable Contraceptives: Failure Rate With Typical Use Within the First Year The contraceptive methods presented in this chart have nearly equal failure rates – from 0.05% for implants to 3% for pills, the patch, and the vaginal ring – when used correctly and consistently. When measured according to typical use, failure rates increase among the cyclic methods (e.g., daily pills, weekly patches, monthly rings) and other periodic methods (i.e., the injectable method) when compared to longer term “forgettable” methods (i.e., intrauterine contraceptives and contraceptive implants). With typical use, 3% of women who use an injectable contraceptive experience an unintended pregnancy. Reference: Hatcher RA. Depo-Provera injections, implants, and progestin-only pills (minipills). In: Hatcher RA, Trussell JA, Stewart F, Nelson AL, Cates W Jr, Guest F, Kowal D, eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media, Inc.; 2004: 0.5% 0.1% 0.05% Combined Oral Contraceptive Patch Ring Injectable Contraceptive IUD Implant Female Sterilization Hatcher R. In: Contraceptive Technology. 18th rev ed. 2004:

Subcutaneous DMPA : Decreased Bleeding Over Time
Percentage of Patients Reporting Subcutaneous Depot-Medroxyprogesterone Acetate: Decreased Bleeding Over Time Continued use of injectable depot-medroxyprogesterone acetate (DMPA) results in endometrial suppression. DMPA use results in changes to the normal menstrual cycle that result in irregular and unpredictable bleeding, which is often characterized as spotting or as light bleeding rather than as heavy menstrual flow. This decrease in menstrual blood loss may result in a decrease in the pain associated with menstruation. Bleeding data were collected in two large, open-label studies of subcutaneous DMPA (DMPA-SC). A total of 16,023 women received DMPA-SC (104 mg) every 3 months for 1 year. Bleeding data were collected in patient diaries. The above graph illustrates that the percentage of women who become amenorrheic after one year of use increases with the use of DMPA-SC, whereas the percentage of women reporting irregular bleeding decreases. References: Jain J, Jakimiuk AJ, Bode FR, Ross D, Kaunitz AM. Contraceptive efficacy and safety of DMPA-SC. Contraception. 2004;70: Jain J, et al. Contraception. 2004;70:

DMPA: Changes in Bone Mineral Density Over Time
* Mean Change in Lumbar Spine Bone Mineral Density (%) * * * Injectable Depot-medroxyprogesterone Acetate (DMPA): Changes in Bone Mineral Density Over Time Bone mineral density (BMD) changes in new users (n=248) of injectable depot-medroxyprogesterone acetate (DMPA; 150 mg) were compared with users of nonhormonal contraceptives (n=360) in this prospective, matched-cohort, clinical study. Participants were followed up to 240 weeks of treatment and to 96 weeks after treatment. Significant decreases in the BMD in the lumbar spine and total hip from the baseline examination were observed at 24 weeks; this decrease persisted throughout the 240 weeks of treatment. Posttreatment, significant increases in BMD were observed up to 96 weeks, suggesting recovery in BMD following discontinuation of injectable DMPA. In 2005, the FDA approved updated labeling information for Depo-Provera to alert health-care providers and patients that long-term use of injectable DMPA is associated with decreased bone mineral density. The updated label recommends that DMPA should only be used long-term (e.g., for more than 2 years) if other contraceptive methods are contraindicated. Women who use injectable DMPA should be counseled to exercise regularly and to ingest adequate amounts of calcium from foods and supplements. Reference: Kaunitz AM, Miller PD, Rice VM, Ross D, McClung MR. Bone mineral density in women aged years receiving depot medroxyprogesterone acetate: recovery following discontinuation. Contraception. 2006;74:90-99. * * * * During Treatment Posttreatment (Weeks) *P<0.001 Kaunitz AM, et al. Contraception. 2006;74:90-99.

Cumulative Contraception Rate (%)
Return to Fertility Cumulative Contraception Rate (%) Return to Fertility After Cessation of Injectable Depot-Medroxyprogesterone Acetate (DMPA) This graph shows the difference in the return to fertility for users of nonhormonal contraceptives and users of depot-medroxyprogesterone acetate (DMPA). Nonhormonal methods do not cause a delay in the return to fertility; 50% of women who stop using these methods will conceive within 3 months. With DMPA, there is generally a 4-month delay in the return to fertility after the last injection. However, since the contraceptive effects of the injection last approximately 14 weeks, fertility would not logically return until after its effects have cleared the body. By 10 months, 50% of former DMPA users will be fertile. Reference: Schwallie PC, Assenzo JR. The effect of depo-medroxyprogesterone acetate on pituitary and ovarian function, and the return of fertility following its discontinuation: a review. Contraception. 1974;10: *Intrauterine device or other barrier method. Schwallie PC, Assenzo JR. Contraception. 1974;10:

Timing of DMPA Initial injection: On day 1 to 5 of menstrual cycle
Within first 5 days of the postpartum period if not breastfeeding After the 6th postpartum week if breastfeeding Immediately or within the first 7 days after an abortion Reinjection: At week 11 to 13 If injection is missed or late (+14 weeks), back-up contraception should be used and absence of pregnancy should be confirmed Timing of Depot-Medroxyprogesterone Acetate Injection: FDA Labeling To ensure that the patient is not pregnant at the time that depot-medroxyprogesterone is initiated, the first injection should be administered between days 1 and 5 of the menstrual cycle. Women who are not breastfeeding can receive an initial injection within the first 5 days after delivery, whereas women who are breastfeeding can receive the initial DMPA injection after the 6th postpartum week. Women who undergo an abortion can receive the initial DMPA injection immediately afterward or within the first 7 days. Reinjection should occur at weeks If an injection is missed or not received by week 14, back-up contraception should be used and the absence of pregnancy should be confirmed before the next injection is administered. Reference: Hatcher RA. Depo-Provera injections, implants, and progestin-only pills (minipills). In: Hatcher RA, Trussell JA, Stewart F, Nelson AL, Cates W Jr, Guest F, Kowal D, eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media, Inc.; 2004:

Implants Implanon

Contraceptive Implants: Characteristics
Serum levels of etonogestrel are detectable within hours of insertion Suppresses ovulation Occurs within 1 day of insertion Ovulation in <5% of users after 30 months of use Rapid return of fertility Menstrual cycle returns within three months Continuous contraceptive protection for three years Does not contain estrogen Appropriate for lactating women after the fourth postpartum week No fluctuating hormone levels Inconspicuous Requires clinician visit for insertion and removal Does not protect against sexually transmitted infections Contraceptive Implants: Characteristics In women who use the contraceptive implant IMPLANON™, serum levels of etonogestrel are detectable within hours of insertion and are undetectable within a week after removal. IMPLANON provides three years of continuous protection from pregnancy. In most women, menses returns to normal within three months of implant removal; 13.8% of women who do not use another form of contraception after removal become pregnant within 90 days. Because contraceptive implants do not contain estrogen, they can be used by lactating women as soon as the fourth postpartum week. This feature may be especially attractive to women with young infants who want highly effective contraception without having to take daily action. Although the insertion and removal of IMPLANON is easy, a trained clinician must perform these procedures. The insertion site is the inner side of the nondominant arm at a level six to eight inches above the elbow crease. Although the implant is inconspicuous, both the clinician and patient should be able to feel it once it has been inserted. This method of contraception does not protect against sexually transmitted diseases. References: Croxatto HB. Clinical profile of IMPLANON: a single rod etonogestrel contraceptive implant. Eur J Contracept Reprod Health Care. 2000;5 Suppl 2:21-28. Reinprayoon D, Taneepanichskul S, Bunyavejchevin S, et al. Effects of the etonogestrel-releasing contraceptive implant (IMPLANON) on parameters of breastfeeding compared to those of an intrauterine device. Contraception. 2000;62: Diaz S. Contraceptive implants and lactation. Contraception. 2002;65: Mascarenhas L. Insertion and removal of IMPLANON: practical considerations. Eur J Contracept Reprod Health Care. 2000;5 Suppl 2: Contraceptive Implant Efficacy: Mechanisms of Action Inhibition of ovulation is the primary mechanism of action and occurs within one day of insertion. Pharmacokinetic and pharmacodynamic studies of IMPLANON™ have described its primary mechanism of action to be the inhibition of ovulation through the prevention of the midcycle peak of luteinizing hormone. Although IMPLANON initially suppresses follicular development and estradiol production, ovarian activity slowly increases after six months, and follicle-stimulating hormone and estradiol reach levels that are almost normal. Endogenous progesterone levels remain in the subovulatory range for >3 years in most subjects. In ovarian ultrasound studies, ovulation occurred in <5% of users after 30 months of use. Ovulation was observed in most women within 3 to 4 weeks of implant removal. The pharmacokinetics and pharmacodynamics of IMPLANON indicate that it has high contraceptive efficacy, as reflected in a zero pregnancy rate over 5,629 woman-years of use. References: Bennink, HJ. The pharmacokinetics and pharmacodynamics of Implanon, a single-rod etonogestrel contraceptive implant. Eur J Contracept Reprod Health Care. 2000;5 Suppl 2:12-20. Le J, Tsourounis C. Implanon: a critical review. Ann Pharmacother. 2001;35: Suppresses ovulation Occurs within 1 day of insertion Ovulation in <5% of users after 30 months of use Increases viscosity of the cervical mucous Croxatto HB Eur J Contracept Reprod Health Care. 2000;5 Suppl 2:21-28; Reinprayoon D et al. Contraception. 2000;62: ; Diaz S. Contraception. 2002;65:39-46; Mascarenhas L. Eur J Contracept Reprod Health Care. 2000;5 Suppl 2:29-34.

IMPLANON™ Single-rod implant (4 cm in length and 2 mm in diameter) made of ethylene vinyl acetate and contains 68 mg of etonogestrel Duration of use: 3 years Pearl index: 0.38 with typical use Contraceptive Implants Marketed in the United States: IMPLANON™ IMPLANON™, marketed by Organon USA, Inc., is a single-rod, etonogestrel-releasing system that contains 68 mg of 3-keto-desogestrel with a membrane of ethylene vinyl acetate. It may be used for up to three years but then must be removed and replaced if continued contraception is desired. Removal and insertion may occur in the same clinic visit. With typical use, the pearl index of IMPLANON is 0.38% within the first year. In clinical trials, only six pregnancies were reported in 20,648 cycles. IMPLANON is the only implant that has been approved by the U.S. Food and Drug Administration for use in the United States. References: Croxatto HB. Clinical profile of IMPLANON: a single rod etonogestrel contraceptive implant. Eur J Contracept Reprod Health Care. 2000;5 Suppl 2: Le J, Tsourounis C. IMPLANON: a critical review. Ann Pharmacother. 2001;35: Slide Source: Contraception Online Croxatto HB. Eur J Contracept Reprod Health Care. 2000;5 Suppl 2:21-28; Le J, Tsourounis C. Ann Pharmacother. 2001;35:

Contraceptive Implant: Tolerability
A 2-year study investigated the efficacy and tolerability of IMPLANONTM (N=330) Reasons for discontinuing participation in the study: Irregular bleeding: 13% Other adverse events: 23% Adverse events attributed to the study medication: Acne: 14.5% Emotional lability: 14.2% Headache: 12.7% Weight gain: 12.1% Dysmenorrhea: 9.7% Depression: 7.3% Implant site symptoms: Mild pain of short duration: <5% Contraceptive Implant: Tolerability A two-year study investigated the contraceptive efficacy and tolerability of IMPLANON™ in 330 women. A total of 161 subjects (49%) did not complete the entire two-year study period. The most common reasons for discontinuation were bleeding pattern changes (13%) and other types of adverse events (23%). Discontinuations due to bleeding irregularity was highest in the first eight months and declined thereafter. During the remainder of the study, the mean number of days of bleeding-spotting episodes decreased consistently over time. Other adverse events were generally mild to moderate in intensity and resulted in 23% of discontinuations. For adverse events attributed to the study medication, the most common of these were acne (14.5%), emotional lability (14.2%), headache (12.7%), weight gain (12.1%), dysmenorrhea (9.7%) and depression (7.3%). Fewer than 5% of women experienced implant site symptoms, mainly mild pain of short duration, after insertion or removal. Although not reported in this study, breast pain has occurred in 12.8% of subjects in other clinical trials that have investigated the tolerability of the contraceptive implant. Reference: Funk S, Miller MM, Mishell D Jr, et al. for the IMPLANON US Study Group. Safety and efficacy of IMPLANON™, a single-rod implantable contraceptive containing etonogestrel. Contraception. 2005;71: Slide Source: Contraception Online The IMPLANON US Study Group. Contraception. 2005;71:

Contraceptive Implant: Noncontraceptive Benefits
Changes in Acne (n=315) Changes in Dysmenorrhea (n=315) Percentage change from baseline Contraceptive Implant: Noncontraceptive Benefits A two-year study investigated the contraceptive efficacy and tolerability of IMPLANON™ in 330 women. Three hundred fifteen subjects provided baseline and follow-up information on acne and dysmenorrhea. About the same percentage of subjects had acne at baseline and at follow-up. Among all study subjects, there was no change in acne status. Among acne sufferers, however, 61% reported that their condition had improved or disappeared during treatment and 8% reported a worsening of acne during the study. Approximately 14% of subjects who did not have acne at baseline reported having acne at the end of the study. The percentage of subjects with dysmenorrhea at baseline was almost three times more than at the study conclusion – 59% had it at baseline and 21% had it at follow-up. Reference: Funk S, Miller MM, Mishell D Jr, et al. for the IMPLANON US Study Group. Safety and efficacy of IMPLANON™, a single-rod implantable contraceptive containing etonogestrel. Contraception. 2005;71: Contraceptive Implant: Weight Change Small but steady weight increases can occur in contraceptive implant users. Participants in clinical trials of IMPLANON™ have reported a mean weight gain of 2.8 lbs at the end of the first year and 3.7 lbs at the end of the second year. In a recent study, Funk et al. investigated whether there was a relationship between the adverse events experienced by their subjects and the contraceptive implant. Weight gain was reported by 12.7% of subjects during the study, and 95% of these cases were considered to be related to the study medication. Reference: IMPLANON™ [physician insert]. Roseland, NJ: Organon USA Inc; Funk S, Miller MM, Mishell D Jr, et al. for the IMPLANON US Study Group. Safety and efficacy of IMPLANON™, a single-rod implantable contraceptive containing etonogestrel. Contraception. 2005;71: Decrease No Change Increase Decrease No Change Increase Funk S, et al. Contraception. 2005;71:

Intrauterine Contracetion
IUD IUS IUC

Contraceptive Case A patient wants to get her pap and her IUD but the nurse insists she come on her period for the IUD insertion, who is right? A 29 year old exotic dancer comes for an IUD insertion, her most frequent partner has offered to pay for it, do you recommend this method for her? The nurse asks you if you want to give the patient antibiotics before or after IUD insertion? A patient wants to know fertilization rates with IUDs? Less infection and better removal rate if midcycle insertion

IUC History Guidelines overly restrictive in the past. These obsolete recommendations reflected concerns about infection and resultant infertility. This cloud of suspicion concerning infection has now been lifted from the IUD by data from both cohort and case-control studies. A landmark case-control study from Mexico City showed that among nulligravid women, use of a copper IUD was not associated with tubal infertility; in contrast, prior exposure to Chlamydia trachomatis was associated with a significant increase in risk.[1] Cohort studies from Norway[2] and New Zealand[3] have found that upon discontinuation of an IUD, women had problems with unwanted fertility, not involuntary infertility. Guidelines about appropriate candidates for IUDs were overly restrictive in the past. These obsolete recommendations reflected concerns about infection and resultant infertility. This cloud of suspicion concerning infection has now been lifted from the IUD by data from both cohort and case-control studies. A landmark case-control study from Mexico City showed that among nulligravid women, use of a copper IUD was not associated with tubal infertility; in contrast, prior exposure to Chlamydia trachomatis was associated with a significant increase in risk.[1] Cohort studies from Norway[2] and New Zealand[3] have found that upon discontinuation of an IUD, women had problems with unwanted fertility, not involuntary infertility.

Almost any woman interested in highly effective contraception can use an IUD.
IUDs today are appropriate for women who have never been pregnant as well as for those who have had upper genital tract infection or a prior ectopic pregnancy. For example, the World Health Organization Medical Eligibility Criteria give nulliparity a category 2 rating, meaning that, in general, the benefits of IUDs for such women outweigh the potential harms. A few contraindications exist, such as an established pregnancy, undiagnosed uterine bleeding that might represent cancer, mucopurulent cervicitis, etc. Dr. Grimes: The IUD today is as effective as tubal sterilization, but less expensive, more convenient, safer, and immediately reversible; An IUD should be considered an alternative to interval tubal sterilization, especially for young women, who are at increased risk for later sterilization regret; Today's IUDs are not associated with a significantly increased risk of pelvic inflammatory disease or resultant tubal infertility; Indeed, some tantalizing evidence from a randomized controlled trial in Scandinavia and Hungary suggests that the levonorgestrel device might lower the risk of infection, compared with a woman using a similar copper IUD; IUDs need not be limited to women wanting long-term contraception; short-term use is also appropriate, although the costs per month of protection will be correspondingly higher with shorter use; When amortized over the lifespan of the device, today's IUDs are among the least expensive forms of contraception; Women who have their first levonorgestrel device removed and a second one inserted often have no uterine bleeding; the risk of pregnancy is negligible in the second 5-year interval of use; Women have been studied for up to 20 years with the same copper T 380A device; no pregnancies occurred in the second decade of use, though data became sparse after many years of observation; and A 25-year-old woman can have a copper T380A inserted and possibly never again have to think about contraception.

Leukocytic Infiltration of Superficial Layers of Endometrium in Contact with IUD: Day 16 of Cycle
Intrauterine environment that containes copper ions, enzymes, prostaglandins, and macrophages that creates a hostile environment for sperm and prevents them from fertilizing an ovum, also appears the device disrups the normal division of oocytes and the formation of fertilizable ova Pg is 0.6 percent with perfect use and 0.8% with typical use with 2-10 percen expulsion during first year Size is 35 mm tall and 32 mm wide monofilament polyethylene string CUSafe 300 Fincoid-350 GyneFix Intracervical Fixing Device Sof-T Multiload Mark II

LNG-IUS (Mirena®) Contraceptive efficacy due to cervical mucus change and sperm motility and function inhibition plus weak foreign body action. 20 mcg/d LNG (30 would suppress ovulation). 5 year cumulative failure rate 0.71/100 in 12,000 US women. Spotting for first 3-6 months of use. Low EP rate ( /1000) Rapid return to fertility.

LNG IUS As with other progestin-only methods, persistent follicles can occur (in less than 8 % of women). They do not require treatment. Produces both cervical barrier and intrauterine barrier to fertilizaiton Talking Points Frequency of follicular cysts is no reason for removal of the IUS. Follow-up by ultrasound is recommended until disappearance. While persistent follicles are not a cause for practitioner concern, they may be a concern for patients. Some can reach 3 cm in size, and counseling may need to explain that they are not dangerous and ultimately will go away. Source Pakarinen P I, Suvisaari J, Luukkainen T, Lahteenmaki P. Intracervical and fundal administration of levonorgestrel for contraception: endometrial thickness, patterns of bleeding, and persisting ovarian follicles. Fertil Steril 1997;68(1):59. Pakarinen et al. Fertil Steril 1997;68:59

Candidates for IUDs: ParaGard T380
Nulliparous or parous women No longer a requirement to be mutally monogamous, but do avoid if high risk for STD or PID. Appropriate for all stages of reproductive life whether young, pg spacing or finished with childbearing. Not for someone with post-pg or post-ab infection within the past three months Uterine or cervical cancer Cervical infection Allergies. Women with vascular disease associated with diabetes or lupus. Women with coronary artery disease. Women with cerebrovascular disease. Women with complicated migraine headaches (those with focal neurologic phenomena or which are exacerbated by OC use). Women with increased risk of thromboembolism Women with lipid disorders.

Possible Complications: IUS
Symptoms Consider Return of menstruation Expulsion Fever/chills Infection Continuous bleeding and/or pain after first month post-insertion Perforation, infection, or partial expulsion Irregular bleeding and/or pain in every cycle Dislocation or perforation Missing string

PID Rate by Insertion IUD
Time Since Insertion Combined WHO clinical trial data for all IUDs - 22,908 IUD insertions (per 1000 woman years) Talking Points 22,908 IUD insertions, 51,399 woman-years of use Overall rate of PID was 1.6 cases per 1000 woman years of use This graph shows an exponential decrease in risk after the first month. Even during the first month, the PID rate is only about one in 1000 This is no different than the baseline of all women using no method of contraception An increased risk of PID with IUDs associated with insertion was not seen in the European LNG IUS/Nova T comparative trial Source Farley TM, Rosenberg MJ, Rowe PJ, Chen JH, Meirik O. Intrauterine devices and pelvic inflammatory disease: an international perspective. Lancet 1992 Mar 28;339(8796):785. Farley et al. Lancet 1992;339:785

IUD Counseling No risk of infertility after discontinuing IUC
No increased risk of PID except in the first 20 days after insertion No difference in complications for parous or nulliparous women

IUD Counseling, continued
Cu IUD at any time in the cycle if it is reasonably sure she is not pg, no additional protection is necessary It is not known exactly how soon it becomes effective If she is less than 48 hours postpartum she can have a Cu-IUD, or 4 or more weeks post partum and amenorrhoeic she can have a either IUD inserted Immediately post first trimester abortion and post second trimester she can generally have the IUD inserted Cu-IUD can be inserted within 5 days of unprotected intercourse, not farther as the risk of serious pelvic infection and septic spontaneous abortion If the LNG-IUD has been inserted more than 7 days into the cycle use protection for 7 days

Bleeding with IUD use Spotting or light bleeding is common during first 3-6 months for either IUD NSAIDs Amenorrhea with Mirena doesn’t require treatment Persistent problem work up for gynecologic causes Heavier than normal menses with the Cu-IUD Tranexamic acid (a hemostatic agent) Do NOT use Asprin Treat anemia If anemia persists remove the IUD

Barrier Methods

Contraceptive Cases A 18 year old reports that she and her partner were mutually stimulating each other and suddenly decided to have intercourse, she didn’t want to fuss with her diaphragm so she inserted a vaginal film immediately before penetration, was she protected? A woman’s cervical cap was discolored so she’s been cleaning it with Listerine, is it ok? Your patient is worried about HIV she makes her partner use two condoms but he thinks this is unsafe, who’s right?

Phases of the Cervical Mucus Method
Calendar (or calculation) method Basal body temperature (BBT) method Cervical mucus method (the Billings method) Sympto-thermal method

Barrier Methods Not as effective as hormonal methods
Most require concomitant spermicide Efficacy is highly dependent on consistent and correct use Some require partner cooperation Vaginal insertion and removal may be unacceptable Increased risk of urinary tract infection when used with a spermicide Some require fitting by a clinician Most are less effective in parous women No hormonal side effects Some methods available without prescription Some reduce sexually transmitted infections Barrier Methods: Disadvantages Women who have only occasional intercourse and those who want to avoid the side effects of hormones often prefer to use barrier methods of contraception. Disadvantages of the barrier methods include efficacy that is lower than hormonal methods and highly dependent on correct and consistent use. Importantly, some methods (diaphragm, Lea’s shield®, and FemCap) require fitting by a health-care provider, and all methods should be used with spermicide. In addition, all female barrier methods require vaginal insertion and removal by the patient, which many women may find difficult or unacceptable. Finally, it is noteworthy that all prescription barrier methods (diaphragm, Lea’s shield®, and FemCap) are associated with an increased risk of urinary tract infections, especially when used with a spermicide. These prescription female barriers may also be less effective in multiparous women. References: Warner L, Hatcher RA, Steiner MJ. Male condoms. In: Hatcher RA, Trussell JA, Stewart F, Nelson AL, Cates W Jr, Guest F, Kowal D, eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media, Inc.; 2004: Cates W Jr., Raymond EG. Vaginal spermicides. In: Hatcher RA, Trussell JA, Stewart F, Nelson AL, Cates W Jr, Guest F, Kowal D, eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media, Inc.; 2004: Cates W Jr., Stewart F. Vaginal barriers: the female condom, diaphragm, contraceptive sponge, cervical cap, Lea’s shield and Femcap. In: Hatcher RA, Trussell JA, Stewart F, Nelson AL, Cates W Jr, Guest F, Kowal D, eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media, Inc.; 2004:

Diaphragm Efficacy: In a 28-week multicenter, randomized, parallel group study of unadjusted typical use (with spermicide), the probability of pregnancy was 7.9% Advantages: Can be inserted hours before intercourse Does not require removal between acts of intercourse Cost: Approximately $30.00 Diaphragm The diaphragm is a shallow, dome-shaped latex cup designed to fit over the cervix and block the entry of sperm. During the first year of typical use, 16% of women will experience an unintended pregnancy. The diaphragm can be inserted hours before intercourse and does not require removal between acts of intercourse. Insertion of additional spermicide is recommended for each coital act. References: Mauck C, Callahan M, Weiner DH, Dominik R, for the FemCap Investigators Group. A comparative study of the safety and efficacy of FemCap, a new vaginal barrier contraceptive, and the Ortho All-Flex diaphragm. Contraception. 1999;60:71-80. Trussell J, Strickler J, Vaughan B. Contraceptive efficacy of the diaphragm, the sponge and the cervical cap. Fam Plann Perspect. 1993;25: , Cates W Jr., Raymond EG. Vaginal spermicides. In: Hatcher RA, Trussell JA, Stewart F, Nelson AL, Cates W Jr, Guest F, Kowal D, eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media, Inc.; 2004: Cates W Jr., Stewart F. Vaginal barriers: the female condom, diaphragm, contraceptive sponge, cervical cap, Lea’s shield and Femcap. In: Hatcher RA, Trussell JA, Stewart F, Nelson AL, Cates W Jr, Guest F, Kowal D, eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media, Inc.; 2004: Mauck C, et al. Contraception. 1999;60:71-80; Trussell J, et al. Fam Plann Perspect. 1993;25: , 135; Cates W Jr, Raymond EG. In: Contraceptive Technology. 18th rev ed. 2004: ; Cates W Jr, Stewart FH. In: Contraceptive Technology. 18th rev ed. 2004:

Diaphragm: 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, based on the package insert of the Ortho All-Flex® diaphragm Diaphragm: Disadvantages The diaphragm is a shallow, dome-shaped latex cup designed to fit over the cervix and block the entry of sperm. This method has important disadvantages. The diaphragm must be prescribed and fitted by a health-care provider, inserted and removed by the user, and stay in place for at least 6 hours after intercourse. In addition, the diaphragm must always be used with a spermicide, which should be reapplied before each act of intercourse. Importantly, a variety of factors, including incomplete instructions, can increase pregnancy risk. As with other prescription barrier methods, the use of the diaphragm may increase the risk of urinary tract infections and toxic shock syndrome, especially when used during menses. References: Cates W Jr., Raymond EG. Vaginal spermicides. In: Hatcher RA, Trussell JA, Stewart F, Nelson AL, Cates W Jr, Guest F, Kowal D, eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media, Inc.; 2004: Cates W Jr., Stewart F. Vaginal barriers: the female condom, diaphragm, contraceptive sponge, cervical cap, Lea’s shield and Femcap. In: Hatcher RA, Trussell JA, Stewart F, Nelson AL, Cates W Jr, Guest F, Kowal D, eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media, Inc.; 2004: Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at: Accessed November 27, Foxman, B, Gillespie B, Koopman J, Zhang L., Palin k, Tallman P, Marsh JV, Spears S, Sobel JD, Marty MJ, Marrs CF. Risk factors for second urinary tract infection among college women. Am J Epidemiol. 2000;151: Cates W Jr, Raymond EG. In: Contraceptive Technology. 18th rev ed. 2004: ; Cates W Jr, Stewart FH. In: Contraceptive Technology. 18th rev ed. 2004: ; Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at:

Inserting a Diaphragm and Correct Position of a Diaphragm
Sizes are 50 to 95 mm and change if you change more than 10 lbs, must be left in place for e6 hrs after also, replace your diaphragm q 2 years, typical use failure is 20% and perfect use failure 6%.

Contraindications to Diaphragm Use
Uterine prolapse Large cystocele or rectocoele or poor pelvic musculature Retroversion of the uterus History of toxic shock syndrome Insert up to 6 hrs prior, keep for 24 hrs Current vaginitis or cervicitis Avoid antifungals, antibiotics, petrolum products Repeated urinary tract infections Allergy to latex rubber or spermicide Must use 2 tlbs spoons ( 2/3 full)

FemCap Cost: One FemCap - $68.95 Two FemCaps - $88.95 Efficacy:
First-generation FemCap: In a 28-week multicenter, randomized, parallel-group study, unadjusted pregnancy probability was 13.9% Advantages: Made of hypoallergenic latex-free plastic (silicone) Can be inserted hours before intercourse Can be left in place for 48 hours Lower risk of urinary tract infection than the diaphragm (odds ratio: 0.6 [ ]) FemCap : sizes 22, 26 and 30 The FemCap is a silicone cup (shaped like a sailor's hat) that has been designed to conform to the anatomy of the vagina and the cervix and form a seal over the cervix. Like the cervical cap and the diaphragm, FemCap prevents sperm from passing through the cervix and, therefore, must always be used with a spermicide. The FemCap, distributed by FemCap, Inc., was redesigned in 2003 with a larger rim for parous women and with a strap to facilitate removal. The FemCap is available in three sizes, based on a woman’s obstetrical history. When the first-generation FemCap was used with a spermicide in a 6-month clinical trial, 14% of the women who participated had an unintended pregnancy with typical use. The FemCap has an important advantage over the cervical cap and diaphragm in that it is made of hypoallergenic latex-free material and is suitable for use by people with latex allergies. It can be inserted hours before intercourse and left in place for 6 hours afterward. It can be left in place for a maximum of 48 hours. Other cervical caps have also been introduced. The Prentif cervical cap, which was available in the United States, was removed from distribution in 2005 due to declining sales. The Oves disposable contraceptive cap, which can be worn for up to 3 days, allows couples greater spontaneity. Oves is available in Europe and Canada. References: Shihata AA. The FemCap: a new contraceptive choice. Eur J Contracept Reprod Health Care ;3: Mauck C, Callahan M, Weiner DH, Dominik R, for the FemCap Investigators’ Group. A comparative study of the safety and efficacy of FemCap, a new vaginal barrier contraceptive, and the Ortho All-Flex diaphragm. Contraception. 1999;60: Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at: Accessed November 27, 2006. Trussell J, Strickler J, Vaughan B. Contraceptive efficacy of the diaphragm, the sponge and the cervical cap. Fam Plann Perspect. 1993;25: , 135. Cost: One FemCap - $68.95 Two FemCaps - $88.95 Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at:

FemCap Disadvantages:
Requires a prescription and fitting by a health-care provider (3 sizes: 22 mm, 26 mm, 30 mm) Requires vaginal insertion and removal Spermicide must be reapplied before each act of intercourse Should be worn for 6 hours after last intercourse May increase risk of toxic shock syndrome FemCap The FemCap is a silicone cup (shaped like a sailor's hat) that has been designed to conform to the anatomy of the vagina and the cervix and form a seal over the cervix. Like the cervical cap and the diaphragm, FemCap prevents sperm from passing through the cervix and, therefore, must always be used with a spermicide. The FemCap, distributed by FemCap, Inc., was redesigned in 2003 with a larger rim for parous women and with a strap to facilitate removal. The FemCap is available in three sizes, based on a woman’s obstetrical history. The FemCap has an important advantage over the cervical cap and diaphragm in that it is made of hypoallergenic latex-free material and is suitable for use by people with latex allergies. It can be inserted hours before intercourse and left in place for 6 hours afterward. It can be left in place for a maximum of 48 hours. Other cervical caps have also been introduced. The Prentif cervical cap, which was available in the United States, was removed from distribution in 2005 due to declining sales. The Oves disposable contraceptive cap, which can be worn for up to 3 days, allows couples greater spontaneity. Oves is available in Europe and Canada. References: Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at: Accessed November 27, Mauck C, Callahan M, Weiner DH, Dominik R, for the FemCap Investigators’ Group. A comparative study of the safety and efficacy of FemCap, a new vaginal barrier contraceptive, and the Ortho All-Flex diaphragm. Contraception. 1999;60: Shihata AA. The FemCap: a new contraceptive choice. Eur J Contracept Reprod Health Care. 1998;3: Shihata AA. Eur J Contracept Reprod Health Care. 1998; 3: ; Mauck C, et al. Contraception. 1999;60:71-80.

Lea’s Shield® Cost: $65.00 + $5.00 S/H
Efficacy: In a 6-month trial, the unadjusted pregnancy rate was 8.7% (with spermicide) Advantages: Made of latex-free hypoallergenic plastic (silicone) One size fits most Does not require reapplication of spermicide with each act of intercourse Can be inserted any time before intercourse Can be left in place for 48 hours Lea’s Shield® Lea’s Shield® (distributed by Yama, Inc.) is a female barrier method that was approved by the United States Food and Drug Administration in The device is made of silicone rubber; it is shaped like a bowl with a center valve that allows for the passage of air and cervical secretions and has an anterior loop that facilitates removal. The shield fits into the posterior fornix of the vagina and tightly over the cervix, thereby preventing the passage of sperm. The shield is reportedly as effective as other female barrier contraceptives. Because Lea’s Shield is made of latex-free material, it can be safely used in those with latex allergies. The shield is designed in one size and does not require a fitting by a health-care provider. It can be inserted at any time before intercourse and left in place for up to 48 hours. In addition, reapplication of spermicide is not required with repeated intercourse. In a 6-month trial, the unadjusted life-table pregnancy rate was 8.7 per 100 women for spermicide users and 12.9 for nonspermicide users. There were no pregnancies in nulliparous users. References: Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at: Accessed November 27, Mauck C, Glover LH, Miller E, Allen S, Archer DF, Blumenthal P, Rosenzweig A, Dominik R, Sturgen K, Cooper J, Fingerhut F, Peacock L, Gabelnick HL. Lea's Shield: a study of the safety and efficacy of a new vaginal barrier contraceptive used with and without spermicide. Contraception. 1996;53: Cost: $ $5.00 S/H Can be ordered at Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at: Mauck C, et al. Contraception. 1996;53:

Lea’s Shield® Disadvantages: Requires a prescription
Vaginal insertion and removal Discomfort for one or both partners may occur Should remain in place for 8 hours after last intercourse May increase risk of urinary tract infections and toxic shock syndrome Lea’s Shield® Lea’s Shield® (distributed by Yama, Inc.) is a female barrier method that was approved by the United States Food and Drug Administration in The device is made of silicone rubber; it is shaped like a bowl with a center valve that allows for the passage of air and cervical secretions and has an anterior loop that facilitates removal. The shield fits into the posterior fornix of the vagina and tightly over the cervix, preventing the passage of sperm. Lea’s Shield requires a prescription, which is considered to be a disadvantage for many women. Insertion and removal must be done by the patient and may be difficult for some users. Importantly, one or both partners may experience discomfort leading to discontinuance. As with other barrier methods, Lea’s Shield must be left in place for 8 hours after intercourse, and its use may increase the risk of urinary tract infections and toxic shock syndrome. References: Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at: Accessed November 27, Mauck C, Glover LH, Miller E, Allen S, Archer DF, Blumenthal P, Rosenzweig A, Dominik R, Sturgen K, Cooper J, Fingerhut F, Peacock L, Gabelnick HL. Lea's Shield: a study of the safety and efficacy of a new vaginal barrier contraceptive used with and without spermicide. Contraception. 1996;53: Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at:

Today® Sponge Cost: $17.00 for pack of six sponges Efficacy:
12-month cumulative life-table pregnancy rate is 17.4% Parity affects failure rate: Nulliparous – 9% to 10% Parous – 19% to 21% 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 hr before intercourse Can be left in place for up to 30 hours Today® Sponge The Today® sponge (distributed by Allendale Pharmaceuticals, Inc.) was reintroduced in The sponge is made of soft, disposable polyurethane foam that is impregnated with nonoxynol-9. It provides contraception by serving as a physical barrier between the cervix and sperm, by trapping semen and sperm, and by continuously releasing spermicide. The Today® sponge does not require a prescription. Before insertion, the sponge must be thoroughly moistened with tap water. It can be inserted up to 24 hours before intercourse and can remain in place for multiple acts of intercourse. The sponge should remain in place for 6 hours after intercourse and should not be left in for more than 30 consecutive hours. In a systematic review of randomized controlled trials that compared the vaginal contraceptive sponge with the diaphragm used with a spermicide, the sponge was statistically significantly less effective in preventing pregnancy overall. The 12-month cumulative life-table termination rates per 100 women for overall pregnancy were 17.4 for the sponge versus 12.8 for the diaphragm in a United States trial, and 24.5 for the sponge and 10.9 for the diaphragm in a United Kingdom trial. Similarly, discontinuation rates at 12 months were higher with the sponge than with the diaphragm [odds ratio 1.3; 95% confidence interval (CI) ]. Allergic-type reactions were more common with the sponge in both trials, although the frequency of discontinuation for discomfort differed. The effectiveness of the Today® sponge decreases in parous women, with up to 21% experiencing an unintended pregnancy during the first year of typical use. Other contraceptive sponges are: The Protectaid® sponge is made of polyurethane foam impregnated with F-5 Gel, which contains three active agents: nonoxynol-9, benzalkonium chloride, and sodium cholate. It provides 12 hours of protection and must be worn for 6 hours after the last act of intercourse. A new sponge is not required if multiple acts of intercourse occur during that period. The Protectaid sponge is not available in the United States. The Pharmatex sponge is a foam cylinder impregnated with 60 mg of the spermicide benzalkonium chloride. It may be inserted up to 24 hours before vaginal intercourse, and it must be worn for a minimum of 2 hours after the last act of intercourse. It should not be left in place for more than 24 hours. The Pharmatex sponge is not available in the United States. References: Kuyoh MA, Toroitich-Ruto C, Grimes DA, Schulz KF, Gallo MF. Sponge versus diaphragm for contraception: a Cochrane review. Contraception. 2003;67: Cates W Jr, Stewart FH. Vaginal barriers: the female condom, diaphragm, contraceptive sponge, cervical cap, Lea’s Shield, and FemCap. In: Hatcher RA, Trussell JA, Stewart F, Nelson A, Cates W Jr, Guest F, Kowal D, eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media, Inc.; 2004: Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at: Accessed November 27, Trussell J, Strickler J, Vaughan B. Contraceptive efficacy of the diaphragm, the sponge and the cervical cap. Fam Plann Perspect. 1993;25: , 135. Cost: $17.00 for pack of six sponges Kuyoh MA, et al. Contraception. 2003;67:15-18; Trussell J, et al. Fam Plann Perspect. 1993;25: , 135.

Today® Sponge 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 Today® Sponge The Today® sponge (distributed by Allendale Pharmaceuticals, Inc.) was reintroduced to the market in The sponge is made of soft, disposable polyurethane foam that is impregnated with nonoxynol-9. It provides contraception by serving as a physical barrier between the cervix and sperm, by trapping semen and sperm, and by continuously releasing spermicide. The effectiveness of the Today® sponge decreases in parous women, with up to 21% experiencing an unintended pregnancy during the first year of typical use. Like other barrier methods, use of the Today® sponge requires insertion and removal by the woman and may increase the risk of urinary tract infections and toxic shock syndrome in some women. Other contraceptive sponges are: The Protectaid® sponge is made of polyurethane foam impregnated with F-5 Gel, which contains three active agents: nonoxynol-9, benzalkonium chloride, and sodium cholate. It provides 12-hours of protection and a new sponge is not required if multiple acts of intercourse occur during that period. It must be worn for 6 hours after the last act of intercourse. The Protectaid sponge® is not available in the United States. The Pharmatex sponge is a foam cylinder impregnated with 60 mg of the spermicide benzalkonium chloride. It may be inserted up to 24 hours before vaginal intercourse, and it must be worn for a minimum of 2 hours after the last act of intercourse. It should not be left in place for more than 24 hours. The Pharmatex sponge is not available in the United States. References: Cates W Jr, Stewart FH. Vaginal barriers: the female condom, diaphragm, contraceptive sponge, cervical cap, Lea’s Shield, and FemCap. In: Hatcher RA, Trussell JA, Stewart F, Nelson A, Cates W Jr, Guest F, Kowal D, eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media, Inc.; 2004: Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at: Accessed November 27, 2006. Cates W Jr, Stewart FH. In: Contraceptive Technology. 2004: ; Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at:

Types of Cervical Caps Prentiff Lea’s Shield (Yama Inc)
Oves Cervical Cap (Veos plc) FemCap (FemCap, Inc) Insert behind the pubic bone as far as it can go If greater than 8 hours since insertion give some vaginal estrrogen

Female Condom . Efficacy:
During the first year of typical use, 21% of women experience an unintended pregnancy Advantages: Provides some protection against sexually transmitted infections Does not require a prescription Can be inserted well before intercourse Made of latex-free material (polyurethane) . Female Condom The female condom is a polyurethane sheath that is placed in the vagina before sexual activity. The female condom has two rings—an inner ring that is placed inside the vagina to hold the device in place and an outer ring that covers part of the labia. This design may confer some protection against sexually transmitted diseases that are transmitted via skin-to-skin contact. The female condom is the first female barrier method that provides protection against both pregnancy and sexually transmitted diseases. A clinical study conducted in the United States By French et al. revealed that the female condom is as effective as the male condom in preventing transmission of chlamydia, gonorrhea, and trichomoniasis. Importantly, consistent and correct use of the female condom is associated with an estimated 97.1% reduction in human immunodeficiency virus infection for each episode of intercourse. The female condom is available without a prescription, can be inserted well before intercourse, and can be used by women with latex allergies. References: Minnis AM, Padian NS. Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions. Sex Transm Infect. 2005;81: French PP, Latka M, Gollub EL, Rogers C, Hoover DR, Stein ZA. Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women. Sex Transm Dis. 2003;30: Cates W Jr., Stewart F. Vaginal barriers: the female condom, diaphragm, contraceptive sponge, cervical cap, Lea’s shield and Femcap. In: Hatcher RA, Trussell JA, Stewart F, Nelson AL, Cates W Jr, Guest F, Kowal D, eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media, Inc.; 2004: Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at: Accessed November 27, Trussell 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. Trussell J, et al. Fam Plann Perspect. 1994;26:66-72.

Female Condom . Disadvantages:
May not be as effective against pregnancy as the male condom Must be inserted and removed by woman Available in only one size Labeled for single use May be noisy Outer ring may be visually unappealing and uncomfortable . Female Condom The female condom is a polyurethane sheath that is placed in the vagina before sexual activity. The female condom has two rings—an inner ring that is placed inside the vagina to hold the device in place and an outer ring that covers part of the labia. This design may confer some protection against sexually transmitted diseases that are transmitted via skin-to-skin contact. The female condom is the first female barrier method that provides protection against both pregnancy and sexually transmitted disease. A clinical study conducted in the United States By French et al. revealed that the female condom is as effective as the male condom in preventing transmission of chlamydia, gonorrhea, and trichomoniasis. Importantly, consistent and correct use of the female condom is associated with an estimated 97.1% reduction in human immunodeficiency virus infection for each episode of intercourse. This method also has several important disadvantages. The female condom may not be as effective in preventing pregnancy as the male condom and is only available in one size. Like the male condom, it is labeled for one act of intercourse. Insertion and removal must be done by the woman, which may be difficult for some users. Finally, this device may be noisy and uncomfortable and the outer ring may be visually unappealing. may limit its use. References: Minnis AM, Padian NS. Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions. Sex Transm Infect. 2005;81: French PP, Latka M, Gollub EL, Rogers C, Hoover DR, Stein ZA. Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women. Sex Transm Dis. 2003;30: Cates W Jr., Stewart F. Vaginal barriers: the female condom, diaphragm, contraceptive sponge, cervical cap, Lea’s shield and Femcap. In: Hatcher RA, Trussell JA, Stewart F, Nelson AL, Cates W Jr, Guest F, Kowal D, eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media, Inc.; 2004: Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at: Accessed November 27, 2006. Cates W Jr, Stewart F. In: Contraceptive Technology. 2004: ; Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at:

Male Condom Two Types: Efficacy:
6-month typical-use pregnancy probability: Latex condom - 5.4% Polyurethane condom – 9.0% Advantages: Provides greater protection against sexually transmitted infections than any other method of contraception Provides substantial protection against pregnancy when used with a spermicide Does not require a prescription Can be used with other methods Inexpensive and widely available Two Types: Latex Polyurethane Male Condom The male condom is available in latex and polyurethane. It fits over the penis to prevent the transmission of sperm into the vagina. The male condom is an important method of contraception because it provides protection against both pregnancy and sexually transmitted infections. During the first year of typical use, 15% of women experience an unintended pregnancy. Efficacy can be further increased by the concomitant use of spermicide by the female partner. Other advantages include low cost and widespread availability without a prescription. Importantly, the condom has been recommended for use with both hormonal and barrier methods to provide maximum protection against sexually transmitted infections. Natural skin condoms are made of sheep cecum and are still available at specialty stores. There are few published data regarding clinical efficacy. They may be used over or under a latex condom to prevent against a latex contact allergic reaction for the female or male partner ( Natural skin condoms alone do not reduce sexually transmitted infections. References: Steiner MJ, Dominik R, Rountree RW, Nanda K, Dorflinger LJ. Contraceptive effectiveness of a polyurethane condom and a latex condom: a randomized controlled trial. Obstet Gynecol. 2003;101: Warner L, Hatcher RA, Steiner MJ. Male condoms. In: Hatcher RA, Trussell JA, Stewart F, Nelson A, Cates W Jr, Guest F, Kowal D, eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media, Inc.; 2004: Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at: Accessed November 27, 2006. Steiner, MJ, et al. Obstetrics & Gynecology 2003;101: Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at:

Male Condom Disadvantages: Can be used for only one act of intercourse
Can tear or slip during use, but this is less frequent with lubricated condoms May decrease sexual pleasure May interfere with spontaneity Requires cooperation of male partner Two Types: Latex Polyurethane Male Condom The male condom is available in latex and polyurethane. It fits over the penis to prevent the transmission of sperm into the vagina and is an important method of contraception because it provides protection against both pregnancy and sexually transmitted infection. The male condom also has several important disadvantages. The efficacy of the condom is dependent on correct and consistent use. It can be used for only one act of intercourse and may break during use. In addition, the condom may decrease sexual pleasure, which may limit its use. The use of the male condom requires the consent of the male partner. References: Warner L, Hatcher RA, Steiner MJ. Male condoms. In: Hatcher RA, Trussell JA, Stewart F, Nelson A, Cates W Jr, Guest F, Kowal D, eds. Contraceptive Technology. 18th rev ed. New York: Ardent Media, Inc.; 2004: Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at: Accessed November 27, 2006. Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at:

Contraception: Spermicides
N-9 (menfegol, benzalkonium chloride, chlorhexidine, sodium dousate) Surfactant that destroys sperm cell membrane in concentrations ranging from 1-18%. Insert no more than 1 hour prior to intercourse. FDA mandates that warnings say this product won’t protect against STDs or HIV May damage vaginal mucosa or cervical epithelium, and can and increase STI vulnerability, and FDA mandates these products warn that these products may increase the risk of getting HIV/AIDS from an infected partner Cost: $10.80/tube or for 18 inserts Chemical destruction of sperm in vagina Nonoxynol-9 most common Must be in place prior to intercourse Effectiveness 82-97% Over-the-counter availability Some protection from STIs Requires motivated couple

Contraception Condoms
Over 100 products available in the US 90% are made of latex Animal skin products or polyurethane make of the rest of the products Most are lubricated Note: anal intercourse doubles risk of breakage Extra thick condoms blunt sensation and reduce premature ejaculation $0.50 for latex, 0.80 for poly, several dollars for designer condoms Spermacide reduces shelf life to 2 years, 5 normally 1996 NIH Consensuse Development Conference concluded that barrier methods, including condoms, do not prevent the spread of HPV. But most failures occur because of non use Effectiveness 90-98%About 4% slippage rate and about .5% breakage rates Over-the-counter availability Best protection against STDs Requires motivated couple Appropriate for casual sex partner Appropriate for motivated male Comes in non-latex forms

Condoms, counseling Latex are the best protection against STI, including HIV and HSV Apply over an errect penis immediately before intercourse with half-inch reservoir at the tip of the condom should be created by carefully pinching the tip of the condom after placement Withdrawal should occur prior to loss of erection Hold the rim during withdrawal to prevent spillage Only water based lubricants should be used with the latex condoms Putting it on inside out, taking it out, flipping it over and wearing during intercourse. Completely unrolling it before wearing. Removing the condom during intercourse. Putting the condom on after IC has begun. Using too large a condom.

Sterilization

Contraceptive Cases A 25 year old after delivery wants to know how likely it is she’ll regret it if she has you perform a post partum tubal ligation. A 20 year old G4 P4 says her previous doctor refused to perform her tubal ligation, and she says she’s got insurance from the state now and she wants it done. What do you recommend? A 33 year old wants permanent contraception what technique should you select? A woman wants to know what is her chance of needing a hysterectomy if she gets a tubal? 3.4 times as likely 8% vs 2%, no biologic reason, maybe don’t want to do hyst in fertile women, or women who opt for surgical solutions are always more likely to do so Local anesthesia world wide, general anesthesia in the US 190 million couples world wide use sterilization, 693,000 performed in 2000 in the US (500,000 vasectomies) Electrocoagulation, clips, silicone rings, partial salpingectomy, now microinserts Long term ectopic pregnancy rates: 1/3 of failures Best data from CREST (Collaborative review of sterilization study) and failure rates greater for women <28 than >34 18.5/1000 Risk data, Westhoff and Davis, 2000 No deaths in 9475 cases Morbidity/lesser complications % No difference in morbidity relative to technique Independent predictors: diabetes, prior surgery, obesity, general anesthesia

Usage of sterilization
Female Sterilization Male Sterilization Condom Oral Contraceptive Other Methods Injection % of Women Using Method Choice of Sterilization as a Contraceptive Method Increases With Patient Age Although there are numerous effective contraceptive methods, sterilization is the most prevalent method in the United States. No medical indication restricts a patient’s eligibility for this method. As this graph shows, sterilization becomes a more desirable option as a woman ages. Reference: Chandra A, Martinez GM, Mosher WD, Abma JC, Jones J, for the National Center for Health Statistics. Fertility, family planning, and reproductive health of U.S. women: data from the 2002 National Survey of Family Growth. Vital Health Stat. Washington, DC: U.S. Department of Health and Human Services. 2005;23(25). Age Chandra A, et al. Vital Health Stat. 2005;23(25).

Advantages of Sterilization
Ideal for those desiring no more children Quick recovery Lack of 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 Failure rate 0.5 to 3.6% Advantages of Sterilization Sterilization offers numerous advantages over other methods of contraception. Because sterilization is considered to be permanent, the recipient no longer needs to remember to use protection before intercourse, or take a pill, or change a patch or ring. There also is no need for partner compliance. There are no significant long-term effects from sterilization and it is highly cost-effective. Sterilization is the most desirable method if the woman is certain that she no longer desires to have children. When a vasectomy is selected as the contraceptive method for a couple, the burden for contraception is removed from the female partner. (Patti and Collins, 2000) Unipolar (most efficacious, most dangerous) Bipolar (safest) Filshie (easiest, no long term data) Hulka (least efficacious, most technically dependent) Yoon Band (painful) or Falope-Yoon silicone rings Endoloop Pomeroy (technically difficult) Now Essure approved 11/02 two concentric microcoils in the proximal section of each fallopina tube polyester fibers in the midle stimulates local fibrous tissue ingrowth that occludes the tubal lumen over the course of 3 months Quinacrine in the cavity 190 million couple world wide use sterilization, 693,000 performed in 2000 in the US Popularized after laparoscopic techniques Long term ectopic pregnancy rates Best data from CREST (Collaborative review of sterilization study) Risk data, Westhoff and Davis, 2000 No deaths in 9475 cases Morbidity/lesser complications % No difference in morbidity relative to technique Independent predictors: diabetes, prior surgery, obesity, general anesthesia

Disadvantages of Sterilization
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 Disadvantages of Sterilization The single most significant disadvantage of sterilization is regret for having undergone the procedure. For this reason, comprehensive patient counseling is an extremely important part of the decision-making process. Reversal is possible with some sterilization methods, but the procedure is expensive, requires major surgery, and is not guaranteed. Other disadvantages include the need for aseptic conditions for the sterilization process, surgical equipment, trained clinicians, and anesthesia. Sterilization does not protect against the human immunodeficiency virus or other sexually transmitted infections.

Complications Associated With Sterilization
1 to 2 deaths/100,000 women when compared to a maternal mortality rate of 12.1/100,000 live births Procedural complications Excessive bleeding or hemorrhage Infection Anesthesia-related complications Trauma – tears, perforations, and burns to abdominal organs Ectopic pregnancy – but the risk is lower than for nonsterilized women Complications Associated With Sterilization Major complications from tubal sterilizations are rare. Most complications are prevented by proper patient screening, appropriate surgical experience, technical expertise with the specific sterilization method, correct use of local anesthesia and sedation, and infection-prevention controls. Since no contraceptive method is completely safe, women should be aware of the risk of ectopic pregnancy. Symptoms include a missed menstrual period, reduced menstrual flow, fainting, or lower abdominal pain. Women who are younger (<30 years of age) and have been sterilized have a greater risk of pregnancy than do older women. When a vasectomy is selected as the sterilization method, the couple should use another form of contraception until azoospermia is confirmed. Reference: Peterson HB, DeStefano F, Rubin GL, Greenspan JR, Lee NC, Ory HW. Deaths attributable to tubal sterilization in the United States, 1977 to Am J Obstet Gynecol. 1983;146: Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LR, Trussell J. The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Am J Obstet Gynecol. 1996;174: Peterson HB, et al. Am J Obstet Gynecol. 1983;146:

Female Sterilization: Techniques
Clips – block the fallopian tubes by clamping down and cutting off the blood supply, thereby causing scarring or fibrosis Filshie clip – titanium with a silicone rubber lining Wolf (Hulka) clip – plastic Rings – cinch a loop of the midportion of the fallopian tube Fallope ring – small Silastic band Microinserts – two concentric expanding metal coils surrounding PET mesh fibers that produce a local inflammatory response Female Sterilization: Mechanical Occlusion Techniques The Filshie clip is designed to occlude the fallopian tube with minimal destruction. It is made of titanium with a silicone rubber lining. Using a customized applicator, the surgeon positions the clip, confirms its location across the isthmus of the tube, leaves an equal amount of tube on either side, and locks the clip into place. The remaining tube is considered to be adequate for successful reanastomosis. The technique is easy to learn and has few complications. The spring clip, also known as the Wolf or Hulka clip, occludes the isthmus of the tube by compressing the tube with a gold-plated stainless steel spring when the jaws of the clip are pressed together. Application of the spring clip by laparoscopy requires careful surgical technique to assure that the clip is placed completely across the isthmus of the tube. The Fallope ring is probably the most commonly used method of tubal occlusion. It is a small Silastic (silicone plastic) band with a special applicator that cinches a loop of the midportion of the fallopian tube. Over time, about 3 cm of the constricted tube becomes necrotic and the tubes separate. Similar to the Pomeroy technique in theory, the laparoscopic application of the band is associated with a 2% to 3% incidence of hemorrhage, which results from stretching of the blood vessels underneath the tube or from tearing of the tube itself. Bipolar coagulation may be needed to manage this complication. Postoperatively, patients experience pain as a result of the hypoxic necrosis of the tube within the Fallope ring. This pain subsides within 48 to 96 hours and can be diminished by topical application of an anesthetic at the time the ring is applied. One disadvantage with all the mechanical devices that are used to occlude the fallopian tube is the possibility of procedural errors, such as failing to apply the device completely across the tube or applying the device to the wrong structure (i.e., a ligament). If they are not applied with care, the clips may close prematurely or even dislodge from the applicator and fall into the peritoneal cavity. Microinserts are a relatively new method of occlusion. These concentric expanding metal coils surround a PET mesh filter to create a local inflammatory response. They are inserted bilaterally into the proximal lumens of the fallopian tube with the aid of hysteroscopic visualization. References: Hulka JF, Mercer Jp, Fishburne, JI, et al. Spring clip sterilization: one-year follow up of 1,079 cases. Am J Obstet Gynecol. 1976;125: Yoon IB, King TM, Parmley TH. A two-year experience with the Falope ring sterilization procedure. Am J Obstet Gynecol. 1977;127: Hulka JF, et al. Am J Obstet Gynecol. 1976;125: ; Yoon IB, et al. Am J Obstet Gynecol. 1977;127:

Hysteroscopic Placement of Permanent Birth Control Micro-Insert Within Tubal Lumen
Microinsert coils that are placed hysteroscopically in the cornua Tubal occulsion by tissue in-growth into and around the micro-insert 88% bilateral placement after one attempt, 92% after two procedures, reliance rate about 97% Previous tubal disease, thickened endometrium Alternative methods coming Quinacrine Erythromysin Adiana Female Sterilization: Microinserts Cooper et al. conducted a prospective, phase III, international, multicenter trial to attempt bilateral insertion of a novel microinsert (Essure®) into the proximal fallopian tube lumens as an outpatient procedure. Bilateral placement of the microinsert under hysteroscopic visualization was achieved in 464 (92%) of 507 women. The most common reasons for failure to achieve satisfactory placement were tubal obstruction and stenosis or difficult access to the proximal tubal lumen. More than half of the women rated pain during the procedure as being either “mild” or “none,” and 88% rated their tolerance of the device-placement procedure as being “good” to “excellent.” The average time to discharge was 80 minutes. Sixty percent of women returned to normal function within one day or less, and 92% missed one day or less of work. Three months after the sterilization procedure was performed, correct microinsert placement was confirmed in 96% of patients and tubal occlusion in 92%. Nearly all (i.e., 99%) the women rated their comfort level as being “good” to “excellent” at all follow-up visits. Ultimately, 449 of 518 women (87%) could rely on the microinsert for permanent contraception. After 9,620 woman-months of exposure to intercourse, no pregnancies were recorded. Patients who receive this method of sterilization need to undergo a hysterosalpingogram three months after surgery and must use back-up contraception until occlusion of the fallopian tubes has been confirmed. Reference: Cooper JM, Carignan CS, Cher D, Kerin JF; Selective Tubal Occlusion Procedure 2000 Investigators Group. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol. 2003;102:59-67. Taken from Kerin, Carignan & Cher. The safety and effectiveness of a new hysteroscopic method for permanent birth control. Aust N Z J Obstet Gynaecol 2001;41:

Adiana Delivery: A catheter placed through the operating channel of a small hysteroscope delivers low-power bipolar electrosurgical energy to the tubal orifice. A pushrod then delivers a small porous matrix of material in the tubal lumen. Occlusion: Ingrowth of healthy, vascularized tissue occurs over approximately 3 months, to occlude the tubes. Retention of the matrix and tubal occlusion are documented by both transvaginal ultrasonography and hysterosalpingogram before patients may discontinue additional contraception.

Regret After Sterilization
Years After Sterilization* Characteristic 3 7 14 Overall (N=744) 3.9 7.5 12.7 Age at sterilization 18-30 5.1 10.5 20.3 >30 2.6 4.8 5.9 Married No 4.5 9.4 20.4 Yes 3.6 6.8 10.2 Race White 3.5 6.0 7.4 Black 4.3 21.7 Time between birth of last child and sterilization Postpartum – vaginal 5.6 17.8 Postpartum – cesarean 8.8 14.0 16.1 Interval 15 d-1 yr 3.3 17.6 2-3 yrs 8.2 12.6 4-7 yrs 3.4 7.0 9.5 Female Sterilization: Regret After Sterilization From 1978 to 1986, the Centers for Disease Control and Prevention conducted a prospective multicenter cohort study to assess the effectiveness of various methods of tubal sterilization. A total of 10,685 women at 9 medical centers in the United States underwent tubal sterilization and were followed up from 8 to 14 years. The median age at sterilization was 30 years; most women had been pregnant at least twice. The study participants were followed up at approximately one year. Those who were eligible were interviewed again at 3, 5, 8, and 14 years after sterilization. Actuarial life tables and Cox proportional hazards models were used during the study to identify those groups at greatest risk for having regret about their sterilization. During follow-up interviews, 744 women reported having regret within the 14-year study period. The cumulative probability of regret increased steadily over the follow-up period to a rate of 12.7% by the 14th year. The highest cumulative probabilities of regret at 3 and 7 years were in women whose sterilization procedures were performed postpartum (after cesarean, 8.8% and 14.0%, respectively; after vaginal delivery, 5.6% and 10.2%, respectively) or in those who were younger than 30 at the time of sterilization (5.1% and 10.5%, respectively). Among women who had interval procedures, poststerilization regret at 14 years varied markedly according to the time between sterilization and birth of the youngest child. The overall cumulative probability of regret for the interval group was 10.0%. Similar regret at 14 years was reported by women who underwent sterilization immediately after an abortion (cumulative probability of 10.6% after first-trimester abortion). The cumulative probability of regret at 14 years was higher among women whose sterilizations were performed within one year of the birth of their youngest child (17.6%) or during the postpartum period (16.1–17.8%). The long-term cumulative probability of regret during the 14 years after sterilization was also higher among women who were 30 years of age or younger (20.3%), black (21.7%), or unmarried (20.4%) at the time of sterilization. Reference: Hillis SD, Marchbanks PA, Tylor LR, Peterson HB. Poststerilization regret: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol. 1999;93: * Cumulative probability/100 procedures Hillis SD, et al. Obstet Gynecol. 1999;93:

Surgical Abortion

Pregnancy Termination Counseling
Discuss all options regarding pregnancy Discuss decision-making process Provide information Offer medical abortion Review medical history and discuss previous procedures Referral for long-term counseling

Issues in Elective Termination of Pregnancy
Sonography Need for more comprehensive evaluations Neonatal advances Fetal tissue research Rise in infertility Dearth of adoptive children Advances in assisted reproductive technologies (ART) Selective Termination Rarely medically indicated

(Contraceptive) Cases
A 24 year old with NYHA Class 4 CVD presents because she was told she “has to have an abortion,” do you agree? A 13 year old patient who has never had a pelvic examination presents requesting an abortion under general anesthesia, is this as safe as under local anesthesia? A 28 year old Russian woman presents for her 7th surgical abortion, how do you counsel her?

Preoperative Evaluation
Targeted History Pelvic examination Falls within preset dating criteria Adequate cervical visualization and uterine palpation Patient suitable for local anesthesia Rh typing Hemoglobin Sonography GC/CT testing Review counseling session and the contraceptive alternatives

Vacuum Aspiration

Complications Inability to dilate cervix No tissue or villi obtained
Obvious uterine perforation Immediate hemorrhage Cervical Uterine Severe postoperative pain Endomyometritis Salpingitis Uterine subinvolution Pregnancy continues Ectopic gestation Molar pregnancy Ovarian cyst pathology

Abortion performed without primary surgical intervention
Medical Abortion Abortion performed without primary surgical intervention Has been studied for ECP, induction of labor, treatment of endo and uterine fibroids 2001 about 37,000 had used mifepristone, and now aobut 460,000

Rachel Benson Gold discusses a particularly troubling aspect of state laws in “The Implications of Defining When a Woman is Pregnant,” which appears in the same issue of TGR. According to both the scientific community and long-standing federal policy, a pregnancy is established when a fertilized egg has implanted in the wall of a woman’s uterus. However, definitions of pregnancy in state law vary widely. And although they have not yet been used to impede women’s access to legal hormonal contraceptive methods, such restrictions are a goal of at least some antiabortion and anticontraception activists. Rachel Benson Gold discusses a particularly troubling aspect of state laws in “The Implications of Defining When a Woman is Pregnant,” which appears in the same issue of TGR. According to both the scientific community and long-standing federal policy, a pregnancy is established when a fertilized egg has implanted in the wall of a woman’s uterus. However, definitions of pregnancy in state law vary widely. And although they have not yet been used to impede women’s access to legal hormonal contraceptive methods, such restrictions are a goal of at least some antiabortion and anticontraception activists. To date, 22 states have enacted one or more laws that include a definition of “pregnancy.” The definitions found in 18 of these laws are based on the idea that pregnancy begins at fertilization or conception. The ongoing debate around emergency contraception–a concentrated dosage of the same hormones found in birth control pills–has brought the question of when pregnancy prevention ends and disruption of an existing pregnancy begins to the forefront of public discussion. Attempts to define pregnancy as beginning before implantation could have serious implications for women’s access to both emergency contraceptives and other hormonal contraceptive methods. “The fact is the majority of Americans have sex before marriage; virtually all U.S. women (98%) use a contraceptive method at some point in their lives; and most women rely on contraception, not abstinence, to help them responsibly manage their sexual lives in the long term,” says Dailard. “As long as politicians continue to ignore the realities of women’s lives, the United States will continue to have the highest rates of unintended pregnancy and abortion in the developed world–a dubious honor that most Americans would prefer not to have.”

To date, 22 states have enacted one or more laws that include a definition of “pregnancy.” The definitions found in 18 of these laws are based on the idea that pregnancy begins at fertilization or conception. The ongoing debate around emergency contraception–a concentrated dosage of the same hormones found in birth control pills–has brought the question of when pregnancy prevention ends and disruption of an existing pregnancy begins to the forefront of public discussion. Attempts to define pregnancy as beginning before implantation could have serious implications for women’s access to both emergency contraceptives and other hormonal contraceptive methods.

“The fact is the majority of Americans have sex before marriage; virtually all U.S. women (98%) use a contraceptive method at some point in their lives; and most women rely on contraception, not abstinence, to help them responsibly manage their sexual lives in the long term,” says Dailard. “As long as politicians continue to ignore the realities of women’s lives, the United States will continue to have the highest rates of unintended pregnancy and abortion in the developed world–a dubious honor that most Americans would prefer not to have.”

(Contraceptive) Case A 21 year old patient presents for an abortion but she doesn’t have a positive pregnancy test, she wants a medical abortion, what do you give her?

Medical Abortion Regimens
Progesterone is required for sustaining an early pregnancy and without progesterone the uterus expels the embryo through a prostaglandin-mediated mechanism. Clinically progesterone’s effects can be inhibited by preventing its synthesis or blocking its action at the receptor. Mifepristone binds to the receptor with an affinity of progesterone itself.

Medical Abortion Advantages
Can be performed without delay Avoids surgical and anesthetic risk Potential to increase access through expanding providers (not true) Potential to shield abortion providers (also not true) Increases choice

Medical Abortion Disadvantages
Longer waiting period for completion Requires multiple visits (2-3) Less effective than surgical (95% vs 99%) Not available after about 7 weeks Expense (Cumbersome) regimen Up to 9 weeks has been successful…$80 per dose of 600 mg but could use less Cumbersome regimens, you just have to get used to it

Surgical Abortion Advantages
More effective Shorter time to completion Fewer visits Shorter bleeding duration Always has pathologic confirmation Can be performed in later gestation

Surgical Abortion Disadvantages
More serious risks involved Limited access Requires more equipment and investment Providers more vulnerable to risk

Medical Abortion Counseling
Desires termination of pregnancy Usual method and efficacy of alternatives Risks, side effects, tetarogenicity and adverse events for each medication and for failed medical Informed consent and administer the MifeprexTM Medication Guide and Patient Agreement Medical ascertainment of contraindications to the medications Clarify the amount of pain and the number of visits and the possibility of need for outside medical care at own expense

Mifepristone: Mechanism
Softens and dilates the cervix Causes decidual necrosis by affecting the capillary endothelial cells of the decidua and detachment of pregnancy Increases prostaglandin release Increases uterine contractions and sensitivity to exogenous prostaglandin Decidua is broken, blastocyst detaches, HCG ges down, corpus luteum function decreases, progesterone decreases, increases prostaglandin accumulation and sensitizes the uterus and cervix to their effects.

Mifepristone + Misoprostol
Medical history and physical exam Pregnancy dating (HCG titers if no sac) Rh status and administration of Rhogam Hematocrit or hemoglobin Counseling/informed consent Offer surgical abortion Explain 4 hour waiting requirements of visit 2? FDA wanted both drugs administered in the office Explain only placenta and blood will be visible to the naked eye 2-5% of women will abort after the Mifepristone alone Hct-NAF recommends; PPFA and WHP requires Include GC/CT testing, and offer pap smears if covered

Administer mifepristone 200 mg Schedule the next visit The literature supports home administration safety for the misoprostol, the FDA is not supportive Instructions on self care and how to contact the clinic Provision of emergency contact, verbal and written use instruction 2-5% of women will abort after the Mifepristone alone Store at 25C or 77F, excursions permitted to C and F

Confirm with sonography patient has not aborted (no decisive HCG change for 10d) 6% complete abortion prior to misoprostol If not completed abortion administer misoprostol 400 mcg PO in two 200 mcg tablets (800 PV, done but not licensed in any country) (Observe for 4 hours about 50% will abort) 84% abort within the next 24 hours Monitor patient for home administration Pain medication for cramping and medication for GI symptoms Vicodin, tylox Ibuprofen (but it is anti prostaglandin synthetase) Probably want to send patients home with both to minimize night time phone calls

Return in 7-10 days to confirm abortion by sonography Vaginal bleeding lasts for 17 +/-11 days and tapers off rapidly after initial expulsion, tell patients to expect 9-20 days of bleeding 8-9% of women have bleeding >30 days Pathologic confirmation: decide about tissue disposal if patient should bring the tissue with her The existence of debris in the uterus following the treatment procedure will not necessarily require surgery for its removal Decreasing in hemoglobin concentration, hematocrit and red blood cell count occur in some women who bleed heavily. Hemoglobin decreases of more than 2 g/dl occurred in 5.5% of subjects during the french clinical trials of mifepristone and misoprostol. Clinically significant changes in serum enzyme (SGOT or SGPT or GT) were rarely reported. No specific food or drug interactions have been studied

Medical Abortion Overview
“Expected” side effects “Expected” bleeding “Expected” cramping Medication requirements Hospitalization rates

“Expected” Side Effects
GI: Nausea, Vomiting, Diarrhea Mild temperature elevation (PD effect) Cramping Headache, dizziness Bleeding If throws up with labor or OCs offer antiemetic like Compazine, Tigan or Phenergan

“Expected” Bleeding Bleeding-moderate to heavy
Some clots-small to large Onset average 2-4 hours after misoprostol Heaviest bleeding may last 1-4 hours as pregnancy is expelled Contact us if 2 maxipads/hour for 2 hours: call (pads should be ‘dripping wet’)

“Expected” Cramping Cramps are light to heavy
Pain usually managed with ibuprofen mg/4-6 hours Prescription for acetaminophen with codeine may be given on day 1 or day 3 Night cramping usually worse before expulsion

Ultrasonography HCG Physiology:One week after fertilization the syncytiotrophoblast begins producing HCG Linear rise for the first 6 weeks with doubling time 1.3 days- 2 days Peaks at 9-10 weeks at 50,000 but may range from 20, ,000 After 10 weeks the levels decline and plateau Urine tests are as sensitive as mIU/ml Levels correlate strongly with the gestational age

Ultrasonography

Diagnosis of Complete Abortion
Any abortion without suction curettage must have a confirmatory examination before the patient’s treatment course is complete Ultrasound disappearance of the gestational sac this usually mandates a transvaginal ultrasound Negative pregnancy test (<50 mIU/ml in urine) 90% drop in b-HCG

Management of Complications
Pain: May assess on an Likart scale Temperature: returns to normal 3-4 hours after misoprostol Failure to bleed: Do not treat EP with this regimen Heavy or prolonged bleeding: stops 1-2 hrs after passing pregnancy Rest, heating pads, NSAID or non-ASA Plenty of non-alcoholic beverages Clinician should call back minutes to assess the patient’s condition Completion may take up to 3-4 weeks Return visits are the only way to assure completion 80-85% will abort within two weeks with Mtx-Misoprostol and 95-97% within two weeks with RU486-Misoprostol Get seen promptly if there is no bleeding after the second dose

Complication Rates Surgical abortion: 9/100,000 overall with mortality <1/100,000 Most surgical complications result from instrumentation in the uterus and from second trimester procedures Medical abortion: complications are more difficult to assess: bleeding is expected, it can be heavy, hemorrhage is a complication US Trial 1/859 Tx adverse event rate of 0.17% Specific AEs From Medical Abortions of first 80,000 5 EP, one of which was fatal 13 transfusions (one was EP case) 117 had curettages, nearly all were non-emergent 10 received antibiotics for presumed infection 6 had allergic reactions 50 women had ongoing pregnancies, of which all but two terminated surgically

Conclusions

Conclusions Contraception is good primary prevention of disease
Perceptions of safety and convenience Provider Education Reducing mythology Increasing knowledge of non-contraceptive benefits Many methods available but cost and access seem to still limit their use and increase risk of unplanned pregnancy Most women will use many methods Abortion should be safe, legal and rare

“We have not inherited the earth from our grandparents, we have borrowed it from our grandchildren.”
---attributed to Ancient Chinese

Contraception, Sterilization and Abortion

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Contraception, Sterilization and Abortion

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