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Family Planning

 Overview/Lessons Learned | Contraceptive Methods | Key Issues
Annotated Bibliography | Program Examples | Links | Presentations

Key Issues

This section provides brief summaries of current research related to selected family planning methods; much of this was important in developing the WHO eligibility criteria. Summaries for other methods will be added as part of RHO's quarterly updates. More detailed discussions of specific key issues are included in the Annotated Bibliography.

Be sure to use the Glossary if you are unfamiliar with any of the terms on this page.

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Combined oral contraceptives

Combined oral contraceptives (COCs) are among the most intensely investigated family planning products in history. A growing body of research confirms that COCs are safe for most women and provide significant non-contraceptive health benefits. Recent studies have confirmed that long-term COC use protects against ovarian cancer and endometrial cancer (ARHP Clinical Proceedings, 1997). Results suggest that protection is long-lasting, and may persist for 15 years or more after stopping COC use. Although many previous epidemiological studies indicated a greater risk of liver cancer in women who used combined OCs for a long period of time, new data from several studies suggest the effect of OCs on liver cancer is negligible (MILTS, 1997; Waetjen, 1996). The most important risk factors for liver cancer were confirmed as a prior history of hepatitis B and C (Anonymous, 1997). Analysis of data from epidemiological studies conducted by the Collaborative Group on Hormonal Factors in Breast Cancer identified an overall relative risk of breast cancer associated with ever use of COCs of 1.07. Women who had used COCs within the past 10 years or who were current users were at slightly increased risk. Risk declined over time and disappeared after 10 years. The only subgroup at slightly elevated risk was women who started using COCs before the age of 20 years. For most women, especially those in developing countries, the benefits of effective pregnancy prevention outweigh the very slight increased risk of breast cancer associated with COC use (FHI, 1996; PATH/Outlook, 1997). Another concern has been the risk of certain diseases of the cardiovascular system. While COC use does carry the risk of cardiovascular disease, the risk is very small, except in older women (over age 35) who smoke or women with high blood pressure. Research is ongoing to clarify whether the risk of cardiovascular disease varies with lower-dose formulations, long-term use, and use by younger or older women. The new eligibility criteria provide strong guidance on how to screen women at risk of cardiovascular disease so that COCs are provided properly (WHO, 1996).

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Emergency contraception

 Emergency postcoital contraception can be used to prevent pregnancy after unprotected intercourse. Administration of emergency contraceptive pills within 72 hours of unprotected intercourse, followed by a second dose 12 hours later, is the most common method of emergency contraception. Insertion of an IUD within 5 days of unprotected intercourse also can be used to prevent an unintended pregnancy (Glasier, 1998).

Emergency contraceptive pills (ECPs) have been available since the 1960s, but service delivery protocols were not standardized, many providers did not know about this method, and access has been limited. The safety and effectiveness of ECPs has been well documented (ACOG, 1996; Trussell, 1996; Van Look, 1996) . While several specially packaged products (including PC4, Postinor-2, Preven, and Plan B) have become available in some countries, it is also common practice to use special elevated doses of regular oral contraceptives (see the Emergency Contraception Web Site at opr.princeton.edu/ec/ec.html for information on correct dosages). While the "Yuzpe" regimen (ethinyl estradiol plus levonorgestrel or norgestrel) is most commonly used, research has shown that progestin-only regimens are equally or more effective. Furthermore, a 1998 WHO study that evaluated the safety and efficacy of the Yuzpe regimen and a levonorgestrel-only regimen found that levonorgestrel-only ECPs caused significantly fewer side effects (WHO, 1998; PATH/Outlook, 1999). Research also has shown that the regimen should be started as soon as possible after unprotected sex to maximize effectiveness.

Several efforts are underway to help providers understand the service delivery implications of providing emergency contraception and increase overall access to ECPs (Consortium for Emergency Contraception, 1997; Population Council, 1999; PATH/Outlook, 1996). Key issues of interest include the following: whether making ECPs more widely available will serve as an effective bridge to regular contraceptives; what level of health care provider can dispense ECPs; whether advanced distribution of ECPs will encourage non-use of regular family planning methods; whether additional pill formulations also are effective as ECPs; how to reduce barriers to access; and how to best reach women and service providers with information about ECPs. In the U.S. state of Washington, pharmacist prescribing of ECPs is being evaluated as a method of improving access to services (PATH, 1999).

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Female barrier contraceptives

With the widespread epidemic of sexually transmitted disease and HIV infection, barrier contraceptives have taken on renewed importance in reproductive health programs for infection prevention. WHO recommends that anyone at risk of STDs use condoms and spermicide. What do we know about the effectiveness of female barrier methods in preventing STD transmission? A review of several female barrier methods estimated that they reduce transmission of STDs by 50 to 75 percent (Elias, 1996; Feldblum, 1994). While few data are available on the degree of STD protection conferred by female condom use, use-effectiveness results from U.S. and Thai studies are promising (PATH/Outlook, 1997). In a summary review of the safety, effectiveness, and acceptability of the female condom, WHO estimated that perfect use could possibly reduce HIV transmission by 93 percent (WHO, 1997).

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Spermicides

Research on the effectiveness of spermicides, particularly nonoxynol-9 (N-9), to reduce STD transmission has provided conflicting results. Laboratory tests of N-9 consistently show that N-9 kills HIV and other STD pathogens. Early small-scale studies of N-9 use suggest that it may protect against STDs (Kreiss, 1992; Niruthisard, 1992). Results of a two-year study in Cameroon, however, found that where a high percentage of sexual acts were protected by condoms, use of N-9 (lower-dose film) did not confer additional protection against gonorrhea, chlamydia, or HIV (FHI, 1997). Data presented at the XIII International AIDS Conference indicated that frequent use and higher doses of N-9 can lead to tissue trauma, thus possibly increasing the risk of infection. These latest data show that N-9 is ineffective against HIV transmission among women who use large amounts of spermicide on a frequent basis. Based on data presented at the conference, the U.S. Centers for Disease Control (CDC) recommends that HIV prevention guidelines by revised to indicate that N-9 should not be recommended as an effective means of HIV prevention. UNAIDS and the CDC will convene meetings in the next several months to consider official revisions to public health guidelines for the use of N-9 for HIV prevention and for pregnancy prevention in populations at high risk for HIV.

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Injectable contraceptives

Although injectable contraceptives were developed shortly after COCs, political controversy has limited their availability until recently. DMPA (known widely under the brand name Depo Provera) has been the most widely studied injectable contraceptive. Recent research by the World Health Organization has allayed much of the fear about DMPA and cancer. According to a 9-year WHO study, DMPA did not increase women's overall risk of breast cancer, invasive cervical cancer, liver cancer, or ovarian cancer, and it decreased the risk of endometrial cancer. Women may face a slightly increased risk of breast cancer in the first five years after they start DMPA, perhaps due to accelerated growth of existing tumors (PATH/Outlook, 1992; Lande, 1995). These studies and the 1992 approval of DMPA in the United States has helped pave the way for increased use of both progestin-only and combined injectable contraceptives (PATH/Outlook, 1992).

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Intrauterine devices (IUDs)

The intrauterine device is one of the most commonly used methods of fertility regulation, especially in developing country programs. It is a safe and effective method for women who are in a monogamous sexual relationship and not at risk of sexually transmitted diseases (PATH/Outlook, 1992). WHO estimates that more than 100 million women use IUDs, with more than 74 million users in China alone. A review of studies confirmed that: (1) IUDs are not abortifacients; (2) newer comprehensive IUDs are highly effective and long-lasting; (3) IUDs can be safely used by lactating women; (4) IUD use is not associated with an increased risk of pelvic inflammatory disease (PID), of ectopic pregnancy, or of subsequent infertility (Chi, 1993). The most definitive review of IUD safety, particularly regarding PID, is the World Health Organization review of 12 studies involving nearly 23,000 IUD users around the world (Farley, 1992). That study found that, overall, the rate of PID among IUD users was very low, that the PID rate was highest during the first 20 days after insertion and low and stable after that, even among users who had and IUD in place for eight years or more. PID among IUD users was found to be most strongly related to the insertion process rather than the IUD. Recent efforts by the Technical Guidance Working Group, a panel of family planning experts from around the world, has helped refine key precautions that will help IUD providers minimize PID risk during insertion; chief among these are client screening and aseptic insertion technique (FHI, 1996). Results of a randomized clinical trial in Nigeria found that use of a systemic antibiotic at the time of IUD insertion did not significantly reduce the incidence of PID during the first three months of IUD use. Careful screening of IUD candidates and sterile insertion technique were suggested as more cost-effective interventions to control IUD-related PID than use of expensive antibiotic therapy (Ladipo, 1991).

The newest generations of copper IUDs combine high continuation rates with very low pregnancy rates. Since little can be done to increase the efficacy of these devices, recent research has focused on developing devices to address side effects, particularly bleeding and pain, which account for a significant number removals. The levonorgestrel-releasing IUD, a device with high effectiveness and acceptability, reduces menstrual blood loss compared to pre-insertion levels (Luukkainen, 1995). Frameless IUDs, such as the Gynefix (Kishen, 1998; Van Os, 1998; Wildermeersh, 1999) have been specifically designed to reduce cramping and pain. This device consists of a surgical nylon thread that holds copper sleeves and is anchored to the uterine fundus during insertion. It recently became available in Europe, and is licensed for five-year use. Studies suggest that the Gynefix is as effective as the Copper T380A, and expulsion rates are less than 1 per 100 women years.

Other research has looked at improving IUD services by training non-physicians to provide IUDs. IUD insertions by trained non-physicians is increasing, and some countries, such as the Philippines, have initiated training programs specifically for non-physicians. Studies in Brazil, Turkey, and the Philippines found that trained health care workers can provide IUDs as safely and effectively as physicians in many settings (Farr, 1998). Additional training may be required to ensure correct placement of the IUD in the uterine fundus to reduce the likelihood of expulsions. Training non-physicians to safely and effectively provide IUDs could result in higher use of this method. Recent studies also have investigated the possibility that the increased menstrual bleeding and upper genital tract infections associated with IUDs may increase the risk of HIV among IUD users. Data from several studies, however, have not demonstrated an increased risk (Mati, 1995; Martin, 1998). IUDs generally are not recommended for women at risk of any STD, including HIV (PATH/ Outlook 1999).

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Male condoms

Condoms in various forms have been used for centuries. Since the 1930s latex condoms have been used, though generally not extensively, in many parts of the world to prevent both pregnancy and sexually transmitted diseases (STDs). The promotion of condoms for HIV prevention led to an increase in research and technical knowledge during the past decade and the first substantial modifications in manufacturing of condoms since the 1930s.

If used consistently and correctly, condoms can be very effective. Reviews of literature confirm that condoms can prevent both pregnancy and STDs, including HIV (Lisken, 1990; FHI, 1998; PATH/Outlook, 1994). Laboratory studies show that sperm and disease organisms cannot pass through an intact latex condom. Consistent condom use is very effective at preventing HIV infection, even among serodiscordant couples, where one partner is infected and the other is not. Studies have confirmed that, with consistent condom use, the HIV infection rate among the uninfected partners was less than 1 percent per year (de Vincenzi, 1994). Where one partner is definitely infected, however, inconsistent condom use can be as risky as not using condoms at all.

In actual use, however, couples relying on condoms generally are not as successful at preventing unwanted pregnancy as users of many other methods. Evidence suggests that the individual -- not the condom -- is usually responsible for most condom failures and to inconsistent use, incorrect use, and breakage due to improper use. Breakage rates for high quality condoms are really quite low (less than 1 to 12 per 100 condoms) during either vaginal or anal intercourse. Substandard products, either manufactured badly or stored badly, may have holes or defects that lead to tearing the condom or leakage. Or the failure may be caused by the condom user's behavior. A recent study found that breakage related to: (1) having a male sexual partner, (2) infrequent condom use, (3) having the condom partially slip, and (4) the technique use to don the condom (Richters, 1995). Slippage was related to: (1) young age, (2) having less lifetime condom experience, (3) being circumcised, and (4) the donning technique. These researchers suggest that condom counseling protocols should acknowledge the complexity of condom use.

To improve user acceptability, researchers have developed improved condoms made of non-latex materials, such as polyurethane, that are thinner, and offer improved sensitivity and comfort. As of 1997, the U.S. Food and Drug Administration had approved five male synthetic condoms. Studies are evaluating whether synthetic condoms have higher breakage and slippage rates than latex condoms.

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Hormonal contraception, IUDs, and HIV risk

Hormonal contraception includes a group of modern contraceptive devices such as oral contraceptives (the pill), injectables (DepoProvera, "the shot"), and contraceptive implants (Norplant). When used properly, these methods, like intrauterine devices (IUDs), provide reliable, consistent protection against pregnancy. Women who use hormonal contraceptive methods or IUDs often are in stable relationships, and use contraception to prevent pregnancy rather than to protection against STD transmission.

Investigators are working to determine if hormonal contraceptives or IUDs themselves might affect a woman's risk of HIV. Some studies have suggested that contraceptives containing high levels of progestins, including injectables and some oral contraceptives, may increase a woman's risk of HIV by promoting certain physiological changes (PATH/Outlook, 1999). Hormonal contraceptives all contain progestins, synthetic versions of the hormone progesterone, and also may contain estrogen. Progesterone has been found to cause endometrial, cervical mucus, and bleeding changes that might affect STD/HIV risk (Mostad, 1997). Estrogen alters the degree of cervical ectropion, which may affect users' susceptibility to certain infections.

A Kenyan study of HIV-positive women found that use of oral contraceptives and the three-month injectable DMPA may be associated with increased endocervical shedding of HIV (Mostad, 1997). Another study, among prostitutes in Nairobi, Kenya, concluded that oral contraceptives may increase risk of HIV infection (Plummer, 1991). However, methodological questions concerning both studies have been raised, making it difficult to interpret the results (PATH/Outlook, 1999). Other studies have shown no association between use of hormonal contraception and increased risk of HIV, including a study of Rwandan women attending prenatal and pediatric clinics (Allen, 1991), and a study of Kenyan women attending family planning clinics in Nairobi (Mati, 1995). Concern that increased menstrual bleeding and possible increases in upper genital tract infections might put IUD users at higher risk for HIV has been raised by some studies (Costello Daly, 1994) but discounted by others (Mati, 1995).

Further data are required before definitive conclusions can be made regarding use of hormonal methods or IUDs and the risk of HIV. Family planning providers should inform clients that hormonal contraceptives and IUDs do not protect against STDs, including HIV, and that use of male or female condoms provides is strongly recommended for the protection of for both partners

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Quinacrine sterilization

Intrauterine application of quinacrine hydrocholoride is a method of non-surgical female sterilization that has received considerable attention during the last decade and has generated significant controversy. To date, more than 100,000 women in over 20 countries have been sterilized using this method, mainly in Viet Nam, India, and Pakistan. Inserted directly into the uterus in pellet form, quinacrine liquefies and flows into the fallopian tubes, causing permanent scarring. Although recorded failure rates and persistent side effects related to quinacrine sterilization have been low, controversy has developed around quinacrine's long-term safety, efficacy, and link to upper genital tract infections. As a result, several countries and regulatory agencies, including the U.S. FDA, have taken steps to ban both the manufacture and use of quinacrine for sterilization (PATH/Outlook, 1999).

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Contraceptive research and development

Although more than 100 contraceptive technologies currently are under development, most are modifications of existing products or alternative delivery systems for existing steroids. A systematic review of the environment surrounding contraceptive research and development has documented the many challenges and obstacles to bringing new products to market (National Academy of Sciences/Institute of Medicine, 1994; WHO, 1994). International efforts supported by the Rockefeller Foundation and other donors are working to revitalize the field of contraceptive research and development. Much research is focused on improved barrier methods for women for both pregnancy and STD prevention, menses inducers, and methods for men (PATH/Outlook, 1995). Researchers (including at CONRAD and the Population Council) are working to develop new spermicides and microbicides from compounds such as gramicidin or cholic acid. Also, the development of buffer gels that lower the pH look quite promising.

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Copyright 1997-2000, PATH.

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