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Unplanned pregnancy is an all too common problem in primary care, and health care providers must be both attentive to patient inquiries and actively solicit information about current needs for contraception. Without the use of contraception, 85 percent of women engaging in intercourse become pregnant within 1 year. The probability of conception is 15 to 33 percent per cycle, depending on the frequency of intercourse (once a week versus every other day).! Viable sperm are able to remain in the genital tract for up to 5 days, but the egg, once released, is capable of being fertilized for only about 24 h. The fertile period for women, therefore, lasts about 6 days, ending within 24 h of ovulation.
According to 1995 figures from the National Survey of Family Growth, 31 percent of pregnancies were unintended (65 percent for women under age 20 and 20 percent among women aged 30 to 44). The United States has the highest rate of adolescent pregnancy in the industrialized world; this is not due to higher rates of adolescent sexual activity, but to less use of effective contraception. Ineffective use of contraception is likely related to a combination of limited education and poorer access to services, including lack of subsidized services and supplies. Approximately one-half of adolescent pregnancies occur within the first 6 months of sexual activity, but the averhyage time between initiating sexual activity and seeking contraceptive advice is 1 year. Psychological and social costs of early sexual activity include damaged self-esteem, involvement in exploitive relationships, unsatisfactory sexual experiences and unhealthy patterns of sexual intimacy, and decreased likelihood of completing high school and college education. In addition, unprotected intercourse increases the risk of transmission of sexually transmitted diseaseS (STDs) and AIDS.
Problems with Current Approaches to Family Planning
Patients frequently seek advice and prescriptions for birth control. Approximately 18 percent of women’s contacts with physicians focus on reproductive health, and 7 percent of visits made by women aged 15 to 44 (12.6 million) are for contraceptions In 1990, 59 percent of u.s. women, 15 to 44 years of age, were using contraception. Unfortunately, the figures for non contraceptive use among at-risk women aged 15 to 44 actually increased between 1988 and 1990 (from 7 to 12 percent), and among women aged 15 to 19, 22 percent were sexually active in the past month without using contraception.
Concern About Health Effects
A major reason for lack of use, particularly of the most effective forms of contraception, is a concern about potential health risks and side effects of available methods. In a study of women seeking legal abortion, 93 percent claimed to have adequate knowledge of contraception, but at the time of conception only 11.5 percent used the most effective methods available (oral contraceptives [OCs] or intrauterine devices [IUDs]); concern about side effects was the most common reason for nonuse.
Specific concerns about contraceptive methods were sought in a Finnish study of 3000 women aged 18 to 44 Approximately half the respondents reported a concern about the risks of at least one type of contraceptive; of those, the majority of concerns (71 percent) were about OCs. Specifically, women were concerned about cardiovascular effects, cancer risk, infertility, mood changes, and weight gain. Concerns about the IUD included infection risk, effects on menstruation, and ectopic pregnancy. Interestingly, concerns about OCs were associated in multiple regression analysis with higher education, past experience, and knowledge. In reality, the health risks to women are far less with current methods of contraception than those associated with pregnancy, and some methods reduce the risks for certain health conditions (e.g., use of a combined OC reduces the risk for ovarian and endometrial cancer). Concerns about health risks and women’s past experience should be addressed to assist women in making the best choices among the contraceptive options.
Access And Cost
Effective contraceptive use is also determined by access to health care and financial issues. Because the most effective forms of contraception are prescription products or surgical procedures, patients with poor access to health care or limited financial means will be less likely to use contraceptive methods with greater effectiveness. The combined costs of office visits and medication can prohibit some women from obtaining the most effective contraceptives. Subsidized family planning clinics, with providers located in 85 percent of U.S. counties, are an important source of contraceptive services. In 1994, these clinics served almost 6.6 million women. Many of the largest sites are dependent on federal title X funding. A study from the Alan Guttmacher Institute reported that each year 24 percent of U.S. women obtain family planning services from a publicly funded clinic or a private doctor reimbursed by Medicaid; if these subsidized contraceptive services were not available, women who currently use them would have an estimated 1.3 million additional unplanned pregnancies annually.
Adolescents are faced with an additional barrier to contraceptive health care-concerns about confidentiality. Many adolescents will not initiate a discussion of sexual activity and contraception with a physician if they are concerned about the conversation being shared with their parents. For adolescents in this country, lack of knowledge and difficulty obtaining contraceptives (often because of fear and embarrassment) are common.
In one study, although the majority of adolescents (66 percent) reported that they would like to discuss contraception and that they would like the physician to initiate a discussion, few (22 percent) had actually had a conversation with a health care provider. Information should be readily available, both within schools and in the physician’s office. A substantial body of literature demonstrates either no impact on sexual activity or a decrease with the provision of sex and contraceptive education. Health providers should initiate conversations about contraception at any available opportunity.
Cultural And Religious Perspectives
In considering optimal contraception, women’s religion and cultural affiliation influence choices as well. Within the Roman Catholic church procreation is the main purpose of marriage so natural family planning and abstinence are the only condoned forms of birth control. Less restrictive positions are held by Protestant and Anglican churches where other forms of contraception are accepted. In Judaism, sexual relations within marriage has two roles-procreation and fulfillment of women’s sexual needs; men are duty-bound to propagate, but women are not. Therefore, prohibitions exist for the use of male contraception, including withdrawal, condom use, abstinence, and vasectomy, but other forms are acceptable.
Cultural considerations may be particularly important for immigrant groups. Although Islam, Hinduism, and Buddhism allow contraceptive use, couples may not be comfortable with certain forms of birth control for cultural reasons. For example, among Muslim, Hindu, and Sikh women, modesty may preclude the use of methods that involve self-insertion of a device into the vagina; use of a condom, OC, or IUD may be more acceptable. These aspects of women’s lives must be considered before recommending a birth control method.
Among birth control options, sterilization is the most common method (36 percent of U.S. couples) followed by OCs Cabout 17 percent of U.S. women). Several surveys of U.S. women have reported condoms as the next most frequently used method of birth control (11 percent) followed by spermicide use alone and withdrawal. The diaphragm and periodic abstinence are next most common, followed in frequency of use by IUDs. Natural family planning methods are used by about 1 million ever-married women or between 2 and 3 percent of currently married couples. Progestin implants and douching are reported as the least common methods of birth control. It is estimated that 95 percent of sexually active women use contraception at some time in their lives and that each woman uses up to three different methods.
Important in the discussion of any birth control method is the reported method effectiveness. Method (theoretical failure, assuming perfect use) and user failure rates are often reported, the former determined after removing pregnancies due to imperfect use from the numerator. Unfortunately, optimal statistical methods for reporting accidental pregnancy rates have yet to be developed. The Pearl Index, used in much of the older literature, reports rates of accidental pregnancy per woman-year of use. This method, however, does not account well for the passage of time; it is unable to distinguish between a few women followed over a long period of time and a large number of women followed for a short period of time. The second method uses life table analysis to compute rates as probability of accidental pregnancy within a particular time frame. This method is now the most frequently used although it has been criticized for its lack of precision in identifying patterns of use. For example, this model assumes few drop-outs and that “exposure” to a particular method is continuous over the time period reported; this assumption is not consistent with most studies on contraception. Recently, a pilot study reported the results of a randomized trial for determining contraceptive efficacy using women who desired pregnancy but were willing to be randomized to either delay of conception (through use of the method to be tested) or no method (i.e., attempt to conceive). This strategy may eliminate many of the current biases in determining user efficacy.
For the purpose of this chapter, life table analyses are used to report effectiveness and ranges of effectiveness for typical users, based on the literature. This information is presented . It should be remembered that these “typical user” estimates are usually derived from study data. In practice, failure rates are likely to be higher. For example, in a report based on data from the 1995 National Survey of Family Growth, within 1 year of starting to use a reversible method of contraception, 9 percent of the respondents reported a contraceptive failure. This included 7 percent of women using the OC, 9 percent using male condoms, and 19 percent using withdrawal. In addition, 31 percent had discontinued the use of the initial method selected by 6 months and 44 percent by 12 months because of method-related concerns. Although 76 percent had resumed a method within 3 months, low-income women were found to be less likely to resume any method. This speaks to a continued dissatisfaction with available methods and a need for improved counseling and follow-up.
Surgical sterilization is a safe, effective, and permanent form of contraception. Tubal sterilization is more frequently used by couples than vasectomy. Among u.s. women, 33 percent of those aged 30 to 35 and 50 percent of women over age 40 Use this method. Vasectomy is used for contraception by approximately 11 to 12 percent of U.S. couples. The number of vasectomies performed each year has been relatively stable since
1991 with about 10 vasectomies per 1000 men aged 25 to 49 years. About one million sterilization procedures are performed yearly in the United States.
Mechanism of Action
Female sterilization involves occlusion of the fallopian tubes, which prevents the sperm from uniting with the egg. Tubal ligation is performed using one of five methods for tubal occlusion:
The latter two methods may be more easily reversible. The majority of these procedures are performed either immediately postpartum under general or regional anesthesia or as an outpatient procedure under laparoscopic guidance.
Male sterilization, or vasectomy, involves occlusion of the vas deferens to prevent sperm from entering the ejaculate. As with tubal ligation, the methods of occlusion include ligation, cautery, clips, and combinations of these approaches, with ligation being the most commonly reported procedure. Virtually all vasectomies are performed under local anesthesia, and the majority are performed in physician’s offices (urology, general surgery, and family practice). Percutaneous vasectomy, a technique more recently introduced into the United States, reduces surgery time to 10 mins and significantly decreases the incidence of complications such as infection and hematoma.
The typical failure rate reported for tuballigation is 0.4 percent for the first year . A recent collaborative prospective study of 10,685 women found a higher cumulative failure rate of 18.5 pregnancies per 1000 procedures over 10 years. In this study, younger women (18 to 27), African American women, and those undergoing bipolar or spring clip occlusion methods had the highest failure rates. Failure rates with vasectomy are reported to be between 0.48 and 1.57 percent.
During the planning for tubal ligation, the provider should be aware of hospital or insurance policies for sterilization procedures; for example, forms may need to be completed 30 days prior to anticipated delivery for a postpartum tuballigation if the patient is insured through Medicaid.
Following tubal ligation, women should be informed that recovery from the procedure averages about 4 days. They should plan to rest for the first 24 h and may resume activities gradually over the first week. Bathing may resume after 2 days and intercourse after 1 week. Women should be made aware that, should pregnancy occur, the risk of that pregnancy being ectopic (located outside the uterus, usually in the fallopian tube) is high (up to 50 percent). Women should know the signs and symptoms of an ectopic pregnancy such as absent menses followed by vaginal bleeding and pelvic (adnexal) pain.
Postoperative warning signs for women include fever, bleeding from the incision, and excessive pain; patients with these problems, or women who suspect a pregnancy, should seek immediate assistance. Follow-up in 1 to 2 weeks after the procedure is recommended.
Benefits And Side Effects
The major benefit of sterilization is its high efficacy resulting in freedom from worry about accidental pregnancy. Other advantages include lack of significant long-term side effects, no need for partner compliance, and no need to interrupt lovemaking. Potential short-term complications of these procedures are uncommon and include reactions to anesthesia (rare, but can be severe), bleeding (1 percent), and infection < 1 percent). Following tubal ligation, some investigators report increases in dysmenorrhea and abnormal menstrual cycles compared to control groups of women. These findings, however, are not consistent and may be due to differences in follow-up intervals.
It should be emphasized that sterilization is considered a permanent decision and, although reversal methods exist, success rates for a reversal resulting in a pregnancy are only 70 percent to 80 percent for tubal ligation reversal and about 50 percent for vasectomy reversal. Differences in rates appear to be based on the type of procedure (less success with electrocautery methods for women and with removal of long segments of the vas deferens for men), time since surgery (inversely related to success), and other factors such as age.
Regret about the decision and requests for reversal occur in 2 to 7 percent of individuals. Regret is higher among young patients, those who express a desire for more children, and those who suffer the loss of a child or divorce after the procedure. The issue of possible desire for future children in the case of remarriage or loss of a child should be discussed directly with women/couples seeking sterilization. For individuals or couples who express uncertainty, alternative methods should be strongly considered.
Combined Oral Contraceptives
Combined OCs contain two hormones, estrogen and progestin. The estrogen component of most OCs is ethinyl estradiol (EE). Mestranol, the other estrogen used in OCs, is a prodrug of EE and is less potent (35 ug of EE is approximately equivalent to 50 ug of mestranol). There are eight progestins contained in the current OCs marketed in the United States. They are norethindrone, norethindrone acetate, ethynodiol diacetate, norgestrel, levonorgestrel, norethynodrel, desogestrel, and norgestimate. Gestodene is awaiting approval in the United States. Comparing the different progestins is made difficult by variable progestational, androgenic, and endometrial potency. The biologic (clinical) effect of the various progestins in the current low-dose OCs, however, is similar because of adjustments in dose.
Combined OCs are available in monophasic, biphasic, and triphasic cycles, depending on the number of variations in hormone composition of active pills. Since the Food and Drug Administration (FDA) approval of a combined OC in 1960, the medication has been extensively studied and refined. There has been a continued lowering of the dose of estrogen and progestin, reducing adverse effects without compromising the contraceptive efficacy. In addition, the newer progestins (desogestrel and norgestimate) have greater selectivity (greater affinity for the progesterone versus androgen receptor) and are less androgenic, reducing androgenic side effects and adverse lipid changes. The current OCs can, therefore, be used by a broader group of women and continued by many until menopause.
Mechanism of Aciton
Combined OCs prevent pregnancy primarily by suppressing ovulation through inhibition of the hypothalamic-pituitary-ovarian axis. The feedback to the pituitary, created by the exogenous hormone, prevents the release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) to stimulate the ovary. Estrogenic effects include suppression of FSH, alteration of ovum transport, changes in the uterine environment (via altered uterine secretions and abnormal cellularity that hampers implantation), and acceleration of luteolysis (degeneration of the corpus luteum). Progestin effects include suppression of LH, thickening of cervical mucus (which hampers sperm transport), inhibition of capacitation (activation of enzymes that permit the sperm to penetrate the ovum), slowed ovum transport, altered fallopian tube secretions, and endometrial changes resulting in a decidualized endometrial bed with atrophied glands that hampers implantation.
The OCs are very effective; typical accidental pregnancy rates are about 3 percent. The efficacy of monophasic and multiphasic products is equivalent. Contraceptive failures are largely due to poor compliance, with the most critical error being delayed initiation of the next cycle of pills (potentially interrupting ovarian suppression). Continuance rates are approximately 71 percent at 1 year.
Screening The role of the provider is to screen interested women for risk factors, review side effects, and determine the most appropriate Oc. Combined OCs are a good choice for women who can remember to take pills daily and want to space children. Women with acne, anovulatory or irregular periods, endometriosis, heavy or painful menses, recurrent ovarian cysts, or a family history of ovarian cancer are likely to benefit from the use of combined OCs. Conversely, women who have poor medication compliance, have previously become pregnant while using OCs, are taking long-term medications known to interfere with the effectiveness of OCs or who are over the age of 35 and smoke cigarettes are poor candidates.
Pill Selection Many pill choices are available in the United States. designed to assist clinicians in deciding which pill to prescribey. The steps begin by determining whether a woman; can safely use estrogen (contra indications are listed in the lower left hand side of the figure) and continue by considering the dose of estrogen, the OC cost, and a woman’s needs with respect to side effects. For safety reasons, it is best to start with an OC preparation containing less than 50 j.Lg estrogen; for cost reasons, the generic 35-ug estrogen pills (such as Genora) should be considered initially.
Packets of OCs are available in 28-day and 21 day regimens. The 28-day regimen has seven placebo pills that allow pills to be taken every day. The 21-day regimen does not contain placebo pills, and users take a 7-day pill break after completion of the active pill cycle. Options for starting the pill include the first day of the menstrual period, the first Sunday after the menstrual period begins, or immediately.
Postpartum Period For women in the postpartum period, the OC should be started no sooner than 2 to 3 weeks after delivery to avoid problems with hypercoagulability and the initiation of breast-feeding. No adverse effects on infant growth and development have been reported. For postpartum women who are not lactating, OCs should begin no later than the third week after delivery because ovulation resumes on average around 45 days. Among women who exclusively breast-feed, ovulation rarely occurs before the third month postpartum. Some authors suggest delaying initiation of OCs in lactating women until this time both because of the efficacy of lactational amenorrhea in preventing conception and because of studies indicating a decreased duration of breast-feeding among OC users. Alternatively a progestin-only pill may be considered. The OC may be started immediately after an abortion. Although women who begin the pill by the fifth day of the menstrual cycle are likely fully protected against pregnancy, many practitioners suggest use of a backup method during the first week of use.
Patient Education Women should be instructed to take the OC at the same time every day. Suggesting that the woman associate taking the pill with another activity carried out at the same time each day (meals, bedtime, brushing teeth, removing contacts) may be helpful. For women who may be exposed to STDs, condoms should be advised in addition to the oral contraceptive.
Missed Pills. Women should receive instructions, both verbal and written, about steps to take when active pills (first 21 days of a cycle) are missed. If pills are missed, it is always safest to use a backup form of contraception for the next 7 days.
If it is less than 24 h from the missed pill, women should take the missed pill right away and take the next day’s pill at the usual time. If it is more than 24 h, she should take both the missed pill and current day’s pill at the same time. If more than 24 h and late for the second pill, take that pill right away, discard the first/other missed pills, and continue with the rest of the pills at the usual time.
If any pills are missed from the third week of pills (days 15 to 21), Hatcher et al recommend that women finish the rest of the pack as described above, but refrain from taking a week off pills (or the seven placebo pills of the 28-day packs). Rather, women should begin a new pack immediately to provide greater contraceptive protection. Women should be made aware that they may not have a withdrawal period until the second pack is completed and that this will not harm them.
Two new OC formulations that contain less than 35 ug of EE daily are Alesse and Estrostep. Although these products provide low-dose estrogen options, they resemble the progestin-only oral contraceptives in the increased likelihood of pregnancy if tablets are taken late (> 24 h between doses).
The benefits of OCs are many. As a contraceptive it is highly effective, reversible, and safe. Non-contraceptive benefits are listed in Table 2-1 and include protection against endometrial and ovaran cancer, potentially beneficial effects on the menstrual cycle, lowered risk of ectopic pregnancy, decreased risk of benign breast disease (progestin effect), and improvement in acne and hirsutism. Medical illnesses that may be improved or prevented through use of OCs are osteoporosis, atherogenesis (estrogen increases high-density lipids and lowers low-density lipids), endometriosis, uterine fibroids, and possibly rheumatoid arthritis, peptic ulcer disease, and thyroid disorders.
potential side effects are summarized in Table 2-1. Common side effects can be divided into groups based on the hormone associated with the effect. This grouping may assist in selecting an alternate OC if the particular side effect persists beyond the initial 3 months of therapy.
Common Side Effects Common estrogenic side effects include nausea, increased breast size, fluid retention, and leukorrhea. Cyclic weight gain has also been a reported concern, but a recent report demonstrates only minimal midcycle gain and no overall weight change during a 4-month period for women taking OCS. Breast tenderness and headache may be attributed to either or both estrogen and progestin. Common androgenic side effects include acne/oily skin, depression, fatigue, increased appetite and weight gain, increased breast size and tenderness, decreased libido and sexual enjoyment, and pruritus. Management of common side effects is discussed in the final section of this chapter.
Contraindications are related to side effects and are listed. In addition, a number of potential drug interactions may occur among women on OCs. The drug interactions and appropriate action to take are listed.
Progestin-only contraceptives include Norplant, Depo-Provera, and progestin-only pills (POPs). The Norplant system is a subdermal implant of levonorgestrel. It was approved by the FDA in 1990. The system provides 5 years of effective, reversible contraception. Depo-Provera is a long-acting depot form of the progestin medroxyprogesterone acetate (DMPA) that is administered by intramuscular injection at 3-month intervals. This synthetic progestin has been used worldwide for over 30 years and was approved by the FDA for contraceptive use in the United States in 1992. The POP, sometimes referred to as the minipill, contains a small amount of a progestational agent(0.35 mg norethindrone (Micronor or NOR-QDJ) or 0.075 mg norgestrel (Ovrette) and is taken daily.
progestin-only contraceptives prevent pregnancy via several mechanisms that differ by type of delivery system (i.e., implant, intramuscular, or oral). Although inhibition of ovulation, primarily through suppression of LH, occurs consistently with Depo-Provera, about 30 to 40 percent of women using either Norplant or the POP continue to ovulate. The latter two methods have marked effects on cervical mucus. The mucus thickens and decreases in amount, impeding sperm penetration. In addition, the endometrium becomes thin and atrophic. The endometrial effect appears less important for women using Norplant because fertilization has not been detected in Norplant users. Premature luteolysis may also be an important mechanism with POPs.
The POPs contain a small amount of a progestin and are taken every day with no pill-free interval. Although POPs contain two different progestins, there is no evidence of a clinically significant difference between them.
The published failure rates for Norplant range from 0.04 to 0.2 pregnancies per 100 women in the first year of use with a cumulative rate of 3.7 percent over 5 years. There is some concern about an increased failure rate among obese women, but the extent of the problem is unclear. Depo-Provera has a probability of failure of 0.3 than the combined OCs. In the first year of typical use 1.1 to 13.2 percent of users will become pregnant. In lactating women, however, the POP is nearly 100 percent effective.
Norplant and Depo-Provera are excellent options for women who have difficulty remembering to take pills daily. The POPs should be strongly considered for women who have relative contra indications to combined OCs and for lactating women who are able to take the medication at a consistent time every day. Some studies suggest that milk volume may actually increase in POP users, and no deleterious effects on infant growth or development have been documented.
Norplant insertion is a minor surgica procedure done under local anesthesia. Each Norplant kit comes with detailed step-by-step instructions. Wyeth Laboratories also produces two videotapes at no cost, one for patients and one for providers. In addition, the company will provide a refund if the device is removed within the first 6 months. Continuation rates for the first year are 88 to 95 percent, but by 3 years (the duration necessary to be cost-effective when compared with OCs) only 50 percent of women are still using this method.
The six implants are inserted on the inside of a woman’s upper arm in a fanlike configuration within the first 7 days of the menstrual cycle or immediately after an abortion or delivery to avoid undetected pregnancy. When inserted under these circumstances, contraception is immediate. If inserted at other times a backup contraceptive is recommended if intercourse occurs within 24 h after insertion. The Norplant must be replaced after 5 years.
The progestin-only contraceptives share many advantages including lack of estrogen complications and reversibility (although return to fertility is delayed with DMPA) and the noncontraceptive benefits of scanty or absent menses, decreased menstrual cramping, and decreased anemia. There is also a decreased risk of developing endometrial and ovarian cancer and pelvic inflammatory disease. These agents can be useful in managing pain associated with endometriosis. Unlike POPs and Norplant, Depo-Provera has not been shown to interact with antibiotics or enzyme-inducing drugs; in fact, its use in women with seizure disorders has decreased the frequency of seizures. Women using these methods also have a lower risk of ectopic pregnancy.
Possible side effects are listed in disadvantages to all progestin-only contraceptives are menstrual cycle disturbances, weight gain, lack of SID protection, breast tenderness, and depression.
With respect to weight gain, POPs have a minimal effect, but weight gain with Norplant is on average 5 lb over 5 years and with DMPA it is significant 5 lb in the first year, 8 lb by the second, and an average total of 14 lb after 4 years. Additional disadvantages of Norplant are risks of local pain, bleeding and infection with insertion and removal, relatively high initial cost, and drug interactions. The effectiveness of both Norplant and the POP is reduced when used concomitantly with antiepileptic medications (carbamazepine, phenytoin, phenobarbital, and primidone), rifampin, and phenylbutazone. Risks specific to DMPA are decreased bone density with long-term use (2 to 10 percent lower in one study, depending on site), 23 adverse lipid changes (high-density lipoprotein-C levels decrease), and the delay in return of fertility (6 to 12 months). The main side effects of POPs are acne and irregular bleeding. The incidence of other side effects is low.
Absolute contra indications to progestin-only contraceptives are listed in DMPA should be used with caution in women with cardiovascular disease or women with complications of diabetes because of the unfavorable lipid effect.
Male Condom Male condoms, used for centuries, were initially made from animal tissue and are now made from latex or polyurethane, although a few animal “skin” or natural membrane condoms are still available. Condoms work by preventing sperm from entering the vagina and protect against disease by preventing direct contact between mucosal surfaces during intercourse. “Skin” condoms do not protect against STDs because of small pores present, which permit the passage of viruses. Some condoms are prelubricated and some contain small amounts of spermicide. The addition of spermicide does not appear to improve efficacy, and there has been a report of increased urinary tract infections in women associated with spermicide-coated condoms.
Female Condom The Reality Female Condom is a thin sheath made of polyurethane, which is 7.8 cm in diameter and 17 cm long. The sheath is prelubricated on the inside and contains two flexible polyurethane rings; one lies inside the sheath attached to the closed end and the other forms the external open edge of the device. The former ring is used for insertion and sits inside the vagina similar to a diaphragm, and the external ring remains outside the vagina, Covering part of the perineum and providing protection to the labia and base of the penis during intercourse. It should not be used with a male latex condom; friction from combined use causes the condoms to become dislodged. The female condom appears to offer similar protection against STDs, but has a higher reported failure rate. Experience with this method is limited; however, a recent study from China found high acceptance (90 percent) among 30 couples using the female condom. Eighty-seven percent of the couples reported that the condom was easy to use, 80 percent of the women and 73 percent of the men reported no difference or improved sexual pleasure compared to the male condom, and 55 percent preferred the female condom over the male condom.
Diaphragm And Cervical Cap The contraceptive effectiveness of the diaphragm and cervical cap is due to dual actions; they act as physical barriers to sperm and also hold spermicide near the cervix. The diaphragm is a circular latex cup that is inserted into the vagina and lies covering the cervix from the posterior fornix of the vagina to 1 to 2 em behind the pubic bone, where the anterior rim fits snugly in place . It comes in three types, arching, coil and flat spring, which refers to the construction of the inner edge of the rim. Sizes range from 50 to 95 mm (diameter of the cup), but most women are fitted with a size 60 to 85 nun. The cervical cap is a small latex rubber cup that fits directly over the cervix. It is available four sizes: 22, 25, 28, and 31 mm. The cap is held in place by suction between the cap’s rim and the cervix and proximate wall of the vagina.
Both devices are to be used with a spermicidal cream, jelly, or gel. Although some data indicate a nearly twofold difference in pregnancy rates for diaphragm use without spermicidal, several efficacy studies on the cap found no differences in accidental pregnancy rate for women consistently using spermicide compared to those who did not. Both the diaphragm and cervical cap require fitting by an experienced provider.
Spermicide Spermicidal preparations are composed of a base or carrier and nonoxynol-9, an active spermicidal chemical. The action of spermicide is to kill sperm on contact by inhibiting sperm motility and survival. Spermicides come in a variety of formulations including foams (which add a physical bubble barrier produced by shaking the can prior to foam insertion), jellies, creams, gels, films, suppositories, and vaginal tablets; the first five methods are effective virtually immediately and the remaining two products are active 10 to is min after insertion. Used as a single agent, the contraceptive protection lasts about 1. h; when used with a cap or diaphragm, the jellis and creams last 6 to 8 h. Additional spermicide should be inserted vaginally for repeated acts of intercourse; the diaphragm and cervical cap should not be removed for at least 6 h following intercourse.
The failure rate of the male condom is typically in the range of 4 to 12 percent. Failure is often attributed to slippage and breakage, but these events are relatively uncommon (2 to 3 percent for breakage and 1 to 6 percent for slippage). Higher failure rates are associated with age (25 to 34 years old), years of sexual activity (5 years or more), use of a condom for less than 5 years, and high frequency of sexual intercourse. Use of a condom with a water-based lubricant has been reported to decrease failure rates. Polyurethane condoms appear to have equal efficacy to latex condoms (6-month pregnancy rates with typical use 4.8 percent and 6.3 percent, respectively; 6-month pregnancy rates with consistent use 2.4 percent and 1.1 percent, respectively), In this randomized clinical trial, however, the polyurethane condoms were more likely to break or slip (8.5 percent versus 1.6 percent for latex condoms) and men randomized to use of the latex condom were more satisfied with the method.
Reported efficacy for the diaphragm and the cervical cap is similar however, efficacy of the cap appears to be lower for parous women in whom accidental pregnancy rates are between 26 percent and 36 percent. The use of spermicide only has a reported accidental pregnancy rate of 21 percent. This relatively low rate may be due to the timing of use; spermicide offers the best protection when inserted into the vagina shortly before intercourse. When used only 15 to 30 min prior to intercourse 0 to 2 percent of sperm remain mobile; at longer intervals between spermicidal application and intercourse, less inhibition of sperm motility is noted.
Male Condom The male condom is applied over the erect penis. The condom should be unrolled a short distance over a finger to be certain that it is unrolling properly and to allow a half-inch of empty space to remain at the tip of the condom to hold the ejaculate. This step is unnecessary with reservoir tip condoms. The condom is then gently rolled down the shaft to the base of the penis. Additional lubrication (natural or artificial) is recommended before insertion because condoms are more likely to tear if the vagina or anus is dry.
Female Condom The female condom is inserted into the vagina by pinching together the upper ring, introducing the device into the vagina, and then pushing it into place with the first finger inserted inside the condom to ensure placement over the cervix (similar to the diaphragm). It is higher in cost than male condoms. Problems with slippage have also been reported. If a condom has torn or slipped off during use, spermicidal foam or gel should be inserted immediately. If this is not available, wash the vagina with soap and water. Emergency contraception should be considered.
Unlike male latex condoms, female (polyurethane) condoms may be used with oil-based lubricants or vaginal antifungal preparations. Reality condoms should not be used together with male condoms; this may cause slippage ‘of one or both condoms.
Diaphragm Of the three basic types of diaphragms (arching, coil, and flat spring), most providers use the arching spring (Allflex [Ortho], Koroflex [Holland Rantos], and Ramses Bendex [Schmid]) in sizes 60 to 80 mm. An estimate of the correct size can be obtained by measuring the distance along the examiner’s index finger from the posterior vaginal wall to about 1 cm before the inside of the pubic arch. This estimate would correspond to the diameter of the device.
The diaphragm is inserted by pinching the sides together and gently inserting it into the vagina with a small amount of lubricant on the leading edge. Once inserted, it should cover the cervix and fit snugly in place with the rim in contact with the posterior and lateral vaginal walls and the anterior edge about one fingerbreadth before the pubic arch. It should be comfortable and easily removed by hooking the anterior rim with the examiner’s index finger and gently pulling the device out of the vagina. If the diaphragm is too small, it will be very easy to remove and will sit well back from the symphysis; it will also be more likely to become dislodged during intercourse. If it is too large, it may cause discomfort and may bow or extend beyond the pubic symphysis and not under it. Spermicide cream should be applied to the side of the diaphragm facing the cervix, covering the “cup” and rim, before insertion. The device may be inserted up to 6 h before intercourse, but additional vaginal spermicide (the diaphragm should not be removed for this purpose) may be inserted if intercourse does not occur soon after insertion or for repeated intercourse within 6 h. The diaphragm should be left in place for about 6 h after intercourse and removed within 24 h.
Women (or their partners) can insert the diaphragm while standing, squatting, or lying down. Women usually find it easiest to insert the diaphragm by pinching it between the thumb and third finger of their dominant hand, introducing the device into the introitus, and using the first finger (or the opposite hand) to push the back edge inside the vagina. The device should slide easily in place, but it may spring out of a woman’s hand on initial attempts; she should be warned that this may happen and to not be discouraged. A plastic inserter or introducer can also be used to insert the coil and flat spring types of diaphragms. Removal is accomplished by inserting the first finger under the rim and pushing forward or by rotating the wrist (so that the knuckles of the hand are visible) allowing the device to be hooked by the index finger and pulled out of the vagina.
Benefits And Side Effects Advantages and disadvantages of barrier methods. All offer immediate contraceptive protection and protection against STDs and cervical dysplasia and neoplasia. Spermicides alone, however, may not reduce the risk of STDs. A recent controlled trial of use of latex condoms plus either nonoxynol-9 film versus placebo film by female sex workers in Cameroon found no decreases in the rate of new HIV, gonorrhea, or chlamydia infection.
Although systemic side effects are absent for barrier methods, the diaphragm and cervical cap do increase the risk of TSS (2 to 3 cases per 100,000 users of vaginal barriers). Spermicides are also important as a backup method, as an adjunct used with other methods for additional protection, or as an emergency method if a condom breaks. At this time, condoms are the most effective choice to prevent HIV infection.
Contraindications or cautious use for these devices. The listed contraindications for the cervical cap stem from a controversy over the whether the cap induces cervical dysplasia. The cap is not recommended for use during menstruation because of concern with obstruction to flow and interference with the cap’s suction.
The IUDs have long been an important method of birth control and, in many countries such as China, are the most commonly used method. During the mid-1980s many of these devices were taken off the U.S. market for a number of reasons including lack of profitability and lawsuits charging that IUDs were responsible for injuries to their users. Despite the fact that most of the cases that went to trial were won by the pharmaceutical company, legal fees and lack of insurance led to further with-drawal of IUDs from the U.S. market. Today, only two IUDs are available in the United States, the Cu T 380A (Paragard) and the Intrauterine Progesterone Contraceptive System (Progestasert).
Mechanism Of Action
It is important to inform patients that the research evidence indicates that IUDs act primarily by inhibiting fertilization through multiple effects on sperm and ova. Although the inflammatory response created in the endometrium from the presence of the IUD inhibits implantation, few fertilized ova actually reach the endometrium. In addition, with the hormone-containing IUD, thickening of cervical mucus interferes with sperm motility as well.
The paragard is a T-shaped device made of polyethylene with barium sulfate added for visibility on x-rays. It has copper wire on the vertical stem and on each transverse arm (total surface area 380 mm) and two monofilament threads attached to the base of the stem for removal. The copper IUD prevents pregnancy primarily by preventing fertilization in the majority of instances; using human chorionic gonadotropin assays, fertilization was detected in less than 1 percent of menstrual cycles in IUD users. The copper also acts locally on the endometrium, creating a sterile inflammatory reaction (foreign body response) that prevents sperm from reaching the fallopian tubes; ovulation is not affected. White blood cells may also consume sperm in the uterus. The copper is not absorbed systemically to any significant degree, and the amount of copper released each day is less than the amount consumed daily in a regular diet.
The paragard is highly effective. Rates of accidental pregnancy are between 0.5 percent and 1.5 percent, the latter figure after 7 years of use. The paragard is currently approved for 10 years of continuous use. The effectiveness of the Progestasert IUD is slightly lower than that of the Paragard; 1.5 percent to 2 percent accidental pregnancies are reported in first-year clinical trials. The Progestasert must be replaced yearly. Continuation rates are high for the IUD, about 70 percent in most studies after 1 year. This may be contrasted with a rate of about 40 percent among users of oral contraceptives.
The role of the provider in prescribing the IUD is to screen interested women for risk factors, review important information about the device, obtain written informed consent for placement, provide careful insertion under sterile conditions, and arrange for regular follow-up and quick access to medical care if complications occur.
Patient Education Women should be instructed to check periodically for the IUD string to make sure that the device is in place, particularly over the first few menstrual cycles. Expulsion of the IUD occurs in between 1 and 10/100 women in the first year after insertion. It is more common among younger women and those who have never been pregnant. Women should also be counseled to report any symptoms of pelvic pain,bleeding, malodorous discharge, fever, or a missed period.
Benefits of the IUD include high efficacy, safety, reversibility, and ease of use. In addition, the IUD does not interfere with lactation and these devices have no systemic side effects. Progestasert IUDs have the advantage of decreasing menstrual blood flow by as much as 40 percent. The number of days of light bleeding and spotting, however, may be increased. Copper IUDs lower the risk of ectopic pregnancy by about 50 to 90 percent compared to women using no contraceptive method; however, if pregnancy occurs, there is an increased risk of ectopic versus intrauterine pregnancy. The Progestasert, however, has a rate of ectopic pregnancy 50 to 80 percent higher than in women using no birth control method.
One of the most serious complications of IUD insertion is perforation of the uterus. Fortunately, this complication is rare (approximately 1.2/1000 insertions). A transient increased risk of PID is seen in the first 4 months after the procedure, likely due to the introduction of bacteria into the uterine cavity during the insertion. The risk is fourfold greater in the first month, returning to baseline by 5 months after insertion. A number of factors influence the risk of infection including the type of IUD (the Dalkon shield had the highest risk of infection), exposure to STDs, age (younger women, likely related to these women being less likely to be in monogamous relationships), and duration of use. The risk of contracting severe PID, requiring hospitalization, increases after 5 years of use to about five times the risk of nonusers of IUDs. These infections appear to be caused primarily by Actinomyces. IUDs as well as oral contraceptives appear to alter the vaginal flora, with significantly more anaerobic bacteria isolated compared with barrier method users who maintained a lactobacilli-dominated flora. The significance of this finding is uncertain.
To reduce the incidence of postinsertion pelvic infection, some investigators advocate the use of antibiotics (single 200-mg oral dose of doxycycline, most commonly, or 500 mg erythromycin if breast-feeding or allergic to tetracycline) just before IUD insertion. Although studies show a decreased incidence of infection (31 percent in one large study) with this approach, the number of women who developed PID is too small to confer adequate power to detect a significant difference.
A disadvantage of the paragard is the increased volume of bleeding per cycle (50 to 100 percent increase), which may result in anemia. In clinical trials, this abnormal bleeding resulted in 4 to 15 percent of women discontinuing this method during the first year of use; the higher rates of removal were seen primarily among younger women who may be less tolerant of this side effect.
Absolute contra indications to insertion of an IUD are active or recurrent pelvic infection, known or suspected pregnancy, and a distorted uterine cavity. Cautious use is advised for the other conditions. Women with previous problems with an IUD and difficulty obtaining follow-up or emergency care for complications may also wish to consider another method.
Women with a history of ectopic pregnancy are not candidates for the Progestasert, but may use the Paragard because of its protective effect against ectopic pregnancy and infrequent need for replacement.
Emergency contraception is the use of a drug or device to prevent pregnancy following intercourse. Options for emergency contraception include OCs, levonorgestrel, high-dose estrogen, mifepristone (RU 486), danazol, and insertion of a copper IUD. Of these, the combination of estrogen and progestin (often referred to as the Yuzpe regimen) is the method most commonly used in the United States.
This form of contraception is greatly underutilized, partially due to ignorance on the part of providers and the women they serve. It has been estimated that each year in the United States, wide-spread use of emergency contraception would prevent over 1 million abortions and 2 million unintended pregnancies carried to childbirth. This form of contraception, whether given at the time of the emergency or in advance, has been shown to be cost-effective. In addition, nearly one-half of women with unintended pregnancies report that they would have considered emergency contraception if they had known that it was available.
It is important to stress to patients that emergency contraceptive methods are forms of contraception (preventing pregnancy before implantation) and not abortifacents. Mechanisms of action include inhibition or delay of ovulation if given before ovulation (estrogen/progestin, mifepristone, danazol), interference with fertilization (IUD due to toxic effects on sperm), interference with function of the corpus luteum (mifepristone and possibly estrogen/progestin, danazol, and high dose estrogen), and prevention of implantation Cmifepristone delays endometrial maturation).
The efficacy rates for the methods of emergency contraception along with the timing of use, status of method, and source of data . With respect to efficacy, available data on mifepristone show that this method is more effective than the Yuzpe regimen (100 percent versus 75 to 80 percent of pregnancies prevented) with fewer reported side effects. Unfortunately, this drug is not available in the United States for use as a contraceptive.
In a recent randomized clinical trial of levonorgestrel for emergency contraception versus combined estrogen/progestin, investigators found levonorgestrel to be more effective (85 percent versus 57 percent of expected pregnancies prevented; crude RR for pregnancy 0.36, 95 percent CI .18 to .70). This method also had fewer side effects. The major limitation to use of this drug is the lack of availability of a 0.75-mg tablet. Using current preparations, women would have to take 20 tablets of Ovrette for two doses, 12 h apart, resulting in a large pill burden and high cost (approximately $52).
Emergency contraception is safe and effective for preventing pregnancy following unprotected intercourse. The major side effects of the estrogen/progestin regimen are nausea On up to 50 percent) and vomiting On up to 20 percent). Subsequent menses may be heavier than usual but should occur when expected. Some women have mild mastalgia for a few days after treatment.
Rare cases of venous thrombosis have also been reported, but the rates are far less than the risk of venous thrombosis associated with pregnancy.
The availability of legal abortion has resulted in a large decrease in maternal mortality and morbidity, primarily from causes such as sepsis, hemorrhage, and trauma.43 Unfortunately, there are still 20 million unsafe abortions performed annually worldwide and 200,000 women in developing countries die annually of complications after illegal abortion. Even in the United States, many women do not have access to legal/safe abortion, in a 1990 review of abortion services, 83 percent of counties in the United States had no identified abortion provider. Medical abortion, especially for women with pregnancies under 42 days of gestation, is a safe and effective alternative to surgical abortion and should be considered as an alternative for pregnant women who desire pregnancy termination. Blood loss may be greater with medical abortion, although differences in blood loss do not appear to be clinically important. Although medical abortion is 90 to 95 percent successful, success rates with surgical abortion are higher (98 to 99 percent).
As noted in a recent review of the literature on medical abortion in early pregnancy, either methotrexate or mifepristone (RU 486) plus a prostaglandin (most often misoprostol) are safe and effective medications for this purpose. Mifepristone, however, is not an FDA-approved agent in the United States.
Methotrexate is a dihydrofolate reductase inhibitor that is believed to act by damaging the connection of the trophoblast to the endometrium and also by decreasing trophoblast production of human chorionic gonadotropin.
Efficacy In the first randomized clinical trial of methotrexate (given intramuscularly) followed by misoprostol, investigators found the combination to be more effective than misoprostol alone with a reported efficacy of over 90 percent, Since that time, this group of investigators documented an equally high success rate with oral methotrexate (50 mg), higher success rates with earlier (up to 49 days’ gestation) versus later pregnancies, and higher success rates with higher-dose misoprostol (800 ug versus 600 ug) given at 7 days rather than 3 days following the methotrexate. Completed abortion rates from case series are 88 to 100 percent. In the randomized trial of oral methotrexate, efficacy was decreased with increasing body surface area and the authors suggest that the intramuscular route or higher oral doses be considered for larger women.
Regimen, Progress Of Abortion, And Side Effects Regimens and side effects for methotrexate and misoprostol are provided. Fewabortions 17 percent) occur before administration of misoprostol. Cramping usually begins within hours after the misoprostol and bleeding within 5 h for women with immediate success (75 to 84 percent of women). Pain can usually be controlled with oral analgesics. Approximately 17 percent of women have delayed success, with abortion occurring within 10 to 45 days (median 23 days); these women did not require further intervention. The duration of bleeding regardless of whether abortion is immediate or delayed averaged 9 days total. Bleeding is rarely heavy enough to require transfusion.
Side effects overall are lower with intramuscular administration of methotrexate, with the exception of oral ulcers. Side effects with combination therapy (methotrexate and misoprostol) are similar to those with drug therapy with methotrexate alone.
Mifepristone is a glucocorticoid antagonist and an antiprogestin and acts by antagonizing progesterone receptors in the uterus, thereby causing decidual breakdown and detachment of the embryo. Mifepristone also enhances myometrial contractions by increasing both uterine production of prostaglandins and uterine sensitivity to their effects.
Efficacy The aggregate success rates, based on randomized clinical trials, for the regimen of mifepristone and misoprostol is 93.7 percent (91 to 96 percent). As with methotrexate, success rates are best for women with pregnancies at lower gestational age (:5 49 days), but efficacy from case series reports continues to be over 90 percent for women with pregnancies of up to 63 days’ gestation or less.
Regimen, Progressof Abortion, And Side Effects
The currently recommended In the most recent report of a large case series of mifepristone (600 mg orally once) and misoprostol, termination of pregnancy occurred in 4 percent of women prior to administration of misoprostol, within 4 h after misoprostol insertion in 49 percent of women, and within 24 h in 75 percent of women.
Side effects were rated as severe in some women (30 percent for nausea, 10 percent for vomiting, 3 percent for diarrhea), increased with increasing gestational age, but rarely resulted in hospitalization or need for transfusion.
Medical abortion can be offered earlier than surgical abortion and affords a woman making this difficult decision both privacy and autonomy. Most women will be able to avoid surgical intervention. Despite the high rate of reported side effects, most women report satisfaction with the procedure, and 64 to 95 percent of women would select the method again.
In addition to higher rates of side effects compared to surgical abortion, medical abortion is delayed in a substantial minority of women, particularly for single-drug therapy with methotrexate. There is also a higher failure rate than with surgical abortion and the added inconvenience of several visits that are often required to confirm termination or for further intervention. Women also need to be aware that they will need a suction procedure if abortion is incomplete or pregnancy continues. Misoprostol has been associated with fetal anomalies.
Medical abortion is contraindicated in women whose pregnancies are more advanced than those reported as resulting in successful termination in the clinical trials (within 49 days for Use of methotrexate and 63 days for mifepristone). Medical abortion is also contraindicated for women who have suspected ectopic pregnancy and for women with asthma, cardiovascular disease, heavy smoking, or severe anemia. Some investigators have excluded women aged 35 and older, and less is known about the safety and efficacy of these regimens for these women. Medical abortion should not be attempted in settings where there is not immediate access to surgical abortion.
Method: Screening for safety and optimal Decision-Making
Providing information ahead of time on all available methods of contraception may be the most useful strategy in enhancing use of contraception. In a study conducted in an STD clinic using video presentations and group discussion with three different counseling messages (full choice of women’s barrier methods, female condom counseling only, or enhanced male condom counseling), the reduction in number of unprotected acts of interCourse at 2 weeks (N = 233) was greatest in the full choice arm, as compared with female condom and male condom arms (83 percent, 54 percent, and 39 percent, respectively).
During the initial office examination, the following aspects of the history and physical examination will assist the clinician in providing important risk information for women and their partners to consider in making their initial decision.
Aspects of the medical, menstrual, and sexual history are important in considering birth control options. Contraindications for individual methods are reviewed . Because menstrual patterns may be altered in positive or negative ways by hormonal methods, a review of a woman’s current menstrual pattern is often helpful. Women should be asked whether they have a new partner and a monogamous relationship with a partner. This information is used to determine the need for protection against STDs. It is also important to consider the frequency of intercourse, how effective the method needs to be for the individual and any contraindications to the specific method chosen. Questioning the patient about the desired length of contraception needed will also aid in the de clslon. incorporates many of these questions in an algorithm.
Some practitioners recommend a lipid profile prior to use of OCs in all women in whom individual risk is not known or who have a family history of hyperlipidemia, a first-degree relative with a history of MI before age 50, or for women over the age of 35. Kjos et al.,53 however, found no significant adverse metabolic markers (lipids or carbohydrate) in women over the age of 35 who were long-term users of combined OCs. An author of this chapter (MS) does not perform routine screening beyond annual Pap smears for sexually active women, but reserves laboratory investigation (such as culture for SIDs, blood tests for hemoglobin or hematocrit, liver function, VDRL, rapid plasma reagin, HIV) for patients with risk factors; this is established on an individual basis.
The algorithm presented may be useful in assisting couples or individuals selecting a method of birth control. Condoms should be strongly encouraged for new partnerships, teenage partners, patients with a history of SIDs, and for couples where one partner has a viral SID and the other partner is not infected. When maximal pregnancy protection also is needed, patients should combine condoms with a hormonal method such as the OCs or Depo-Provera. For the majority of women selecting an OC, the appropriate initial dose of EE is 30 to 35 ug; lower-dose OCs or steppedestrogen products can be used for women at risk of thrombotic complications and for those who do alot tolerate standard doses of estrogen. Rarely would a 50ug product be necessary.
It is helpful to mention that periods of abstinence from intercourse may be desired or needed based on medical or social situations. Women may need information on other forms of sexual expression and help in enforcing this decision. Deciding what one wishes to do about sexual intimacy in advance, informing one’s partner Cin advance), and avoiding high-pressure situations are helpful techniques to discuss. Additional techniques, particularly for adolescents, to reinforce a decision for abstinence include saying no clearly and repetitively, providing reasons for the decision “I’m not ready,” “I am concerned about infections”), leaving the situation, double-dating or keeping friends nearby, and threatening to call someone with authority for help.
Common side effects with combined OCs and their management. The most common side effect of POPs is menstrual irregularities. If menstrual irregularities are bothersome, bleedmg patterns may be improved by the administration of prostaglandin inhibitors (NSAIDs). This side effect often decreases over time.
Diaphragm and Cervical Cap
To prevent odor and deterioration, these devices should be cleaned after each use with a mild soap or detergent (avoid deodorant or perfumed soap) and stored in a clean and cool place.
common problems with the IUD and recommended management strategies. If pregnancy should occur with the IUD in place, women should be advised to have it removed immediately. When the IUD is left in place, spontaneous abortion occurs in 50 to 60 percent of intrauterine pregnancies, half during the second trimester, and the risk of premature delivery, stillbirth, and infants of low birth weight are increased. The risk of a septic abortion, while rare, is 26 times more common when the IUD is left in place. The risk of miscarriage is greatly lessened and the risk of septic abortion is eliminated once the IUD is removed.
The newest barrier method awaiting approval is called Lea’s Shield. It is a bowl-shaped silicone device, 55 mm in diameter, thicker posteriorly (to fill the posterior fonix of the vagina) that is resistant to petroleum-based lubricants, does not absorb odors, and does not cause allergic reactions in users with latex sensitivity. It has an anterior loop.Jor ease of removal and a one-way flutter valve to prevent pressure buildup over the cervix. In a phase I trial, no motile sperm were found in the cervical mucus in any cycle in which Lea’s Shield or the diaphragm was used with spermicide. In a phase II trial, 6-month life table pregnancy rates among the 185 women enrolled was 5.6 for spermicide users and 9.3 for nonspermicide users (P = .086).
Newer spermicides are also being developed. Unlike nonoxynol-9, which acts as a detergent degrading sperm as well as some of the natural protective vaginal microorganisms, these new agents are far more specific in action and are designed to interrupt sperm maturation. Chemicals impeding the release of cholesterol from the plasma membrane encasing the sperm head (preventing the membrane from achieving a more fluid state), blocking the calcium channels in the sperm membrane (preventing the acrosome reaction where enzymes are released, allowing penetration of the egg’s coat), and preventing protein binding between the sperm and the zona pellucida are being developed. 55 These should offer greater safety and high efficacy.
Hormonal alternatives for men include a longacting (3-month duration) intramuscular injection of testosterone and progestin or injection of nonpeptide inhibitors, which halt sperm production by reducing the secretion of gonadotropin-releasing hormone. 55 For women, progestin-releasing vaginal devices, with or without estrogen, and dual-rod Norplant devices, which may be biodegradable, are being tested.
A new levonorgestrel-releasing IUD awaiting release has the advantage of the Progestasert in reducing menstrual blood loss but can be left in place up to 10 years. Due to suppression of the endometrium, 83 percent of users in one study had no bleeding or spotting after 1 year of use. No adverse effects on lipids were demonstrated. The efficacy rate is comparable to the Cu T 380A (0.5 percent)
Finally, vaccines for men and women (immuno-contraceptives) are undergoing phases I and II trials. The use of these agents results in the development of antibodies to selected proteins (FSH and LH-releasing hormone for men, human chorionic gonadotropin for women, or sperm antigens) involved in reproduction. These vaccines wili need to be reversible and demonstrated to be safe particularly with respect to inducing unwanted immune responses against other tissues, before they are likely to be released.
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