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Family planning needs: new opportunities, emergency contraception and other new technologies.

Modern contraception is considered to be one the major advances of the 20th century. Yet, as the next century begins, it is estimated that there is still a largely unmet need for contraception, with millions of couples worldwide who express a wish to limit the number of their children but do not use or are not satisfied with their contraceptive method. While the reasons are numerous, it is clear that there is a need for improved and new methods which are easier to use, under the user's control, with fewer side-effects and responding to the needs of different groups of users, including men. To respond to this need, current contraceptive research and development efforts focus on five main areas: emergency post-coital methods, user-controlled long-acting methods, dual protection methods against both pregnancy and sexually transmitted infections, methods for men, and methods with fewer side-effects including some that are more targeted to specific reproductive biological events. A number of leads are presented which are at various stages of development. Concluding remarks stress the numerous challenges of contraceptive development, not the least of which is the vision required of what the needs of future generations will be, since it takes 10-15 years to bring a new contraceptive to the market. More fundamentally, overall progress towards reducing the unmet need for contraception will depend on the status of women, specifically their decision-making power, and access to education and income.

Journal Article↗

Is the intrauterine device appropriate contraception for HIV-1-infected women?

OBJECTIVE: To assess whether the risk of complications is higher in HIV-1-infected women compared with non-infected women in the two years following insertion of the intrauterine contraceptive device. DESIGN: Prospective cohort study. POPULATION: Six hundred and forty-nine women (156 HIV-1-infected, 493 non-infected) in Nairobi, Kenya who requested an intrauterine contraceptive device and met local eligibility criteria. METHODS: We gathered information on complications related to the use of the intrauterine contraceptive device, including pelvic inflammatory disease, removals due to infection, pain or bleeding, expulsions, and pregnancies at one, four, and 24 months after insertion by study physicians masked to participants' HIV-1 status. Cox regression was used to estimate hazard ratios. RESULTS: Complications were identified in 94 of 636 women returning for follow up (14.7% of HIV-1-infected, 14.8% of non-infected). The incidence of pelvic inflammatory disease was rare in both infected (2.0%) and non-infected (0.4%) groups. Multivariate analyses suggested no association between HIV-1 infection and increased risk of overall complications (hazard ratio = 1.0; 95% CI 0.6-1.6). Infection-related complications (e.g. any pelvic tenderness, removal for infection or pain) were also similar between groups (10.7% of HIV-1-infected, 8.8% of non-infected; P = 0.50), although there was a non-significant increase in infection-related complications among HIV-1-infected women with use of the intrauterine contraceptive device longer than five months (hazard ratio = 1.8; 95% CI 0.8-4.4). Neither overall nor infection-related complications differed by CD4 (immune) status. CONCLUSIONS: HIV-1-infected women often have a critical need for safe and effective contraception. The intrauterine contraceptive device may be an appropriate contraceptive method for HIV-1-infected women with ongoing access to medical services.

Adult↗

[Contraception and pregnancy in adolescence]

OBJECTIVE: To review and discuss different contraceptive methods currently used by adolescents, and also discuss adolescent pregnancy, including the associated risks and the importance of prenatal care. METHODS: Review of literature and clinical experience with different contraceptive methods and with adolescent pregnancy. RESULTS: The oral contraceptive pill is the most common method used by teenagers due to its low failure rate and other non-contraceptive effects. Emergency contraception is a good option in cases of rape, unplanned sexual intercourse, condom rupture, nonuse of oral contraceptives during short intervals. In this case, the pill should be taken within 72 hours after the intercourse (preferably before 24 hours for best effect). Most problems related to adolescent pregnancy have a social or economic origin; however, some medical complications such as preterm labor and anemia are frequently reported. CONCLUSIONS: The use of male and female condoms combined with other contraceptive methods should be encouraged to prevent sexually transmitted diseases. If pregnancy is confirmed, prenatal care must be implemented as soon as possible in order to minimize the risks of complication and to allow for an effective multidisciplinary approach.

Journal Article↗

Contraceptive Options for Perimenopausal Women.

A number of safe and effective contraceptive choices exist for the perimenopausal woman. With increasing experience, we have learned that hormonal methods are safer than initially thought, particularly with the lower-dose formulations currently prescribed. Furthermore, the pill offers many noncontraceptive health benefits. And while progestins, in contraceptive doses, have a slight adverse impact on the lipoprotein profile, there has been no parallel increase in clinical cardiovascular disease. Since elimination of the Dalkon shield, the IUD has been recognized as a very safe and effective method of contraception; the risk of associated infection seems primarily related to the insertion procedure. Barrier methods provide somewhat reliable contraception, with varying degrees of added protection against STD. The decreased fertility rate among perimenopausal women allows some latitude when contraceptive methods with suboptimal efficacies are selected; however, unintended pregnancy is a significant problem for women older than 40 years, should it occur. Surgical sterilization remains the most popular form of contraception among perimenopausal-aged couples. Natural family planning techniques are safe and somewhat underutilized. All women should be counseled about the availability of postcoital contraceptive methods.

Journal Article↗

Plasma levels of ethinylestradiol (EE) during cyclic treatment with combined oral contraceptives.

The purpose of the present study was to extend the still limited data concerning ethinylestradiol (EE) plasma levels after repeated daily ingestion of a combination pill during the course of classical cyclic treatment. Plasma EE levels were followed in 13 volunteers throughout, in total, 19 treatment cycles with either a 50 ug EE (+ 125ug d-norgestrel) or a 30 ug (+ 150ug d-norgestrel) containing oral contraceptive. In addition, single plasma EE determinations were performed in 110 chronic oral contraceptive users. Whereas different patterns in plasma EE levels (sampling 24 hours following last pill ingestion) were observed among the different volunteers, the mean levels increased progressively during treatment and reflected closely the differences in dosage. The values obtained in the volunteers at the end of the treatment cycle showed important interindividual variations. The findings during a first treatment cycle or during the following ones were similar and for different treatment cycles in the same patient, the patterns in plasma EE levels were consistent. The results for single plasma determinations in chronic contraceptive users (sampling between 8th and 21st day of treatment cycle, 9 to 24 hours since last pill ingestion) showed more pronounced interindividual variations, the individual EE levels being not correlated to parameters such as body weight, body surface, months of oral contraception prior to the study, sex hormone binding capacity or day of the cycle. However, significant differences in mean plasma EE levels were noticed for patients treated with different commercial preparations with identical EE content, suggesting the existence of differences in bioavailability. The relevancy of plasma EE determinations is discussed and from the results of the present study, it is concluded that a strictly standardized time of sampling is an absolute condition for obtaining interpretable results.

Contraceptives, Oral↗

Interrelationship of serum levonorgestrel and sex hormone-binding globulin levels following vaginal and oral administration of combined steroid contraceptive tablets.

Ten women were treated daily with a standard dose contraceptive tablet containing 0.25 mg levonorgestrel (LNG) in combination with 0.05 mg ethinylestradiol. Five women used the tablet vaginally, while the other five used it orally. Blood samples were taken at frequent intervals on the first day of treatment and after 1 and 2 hours on treatment days 7 and 14. Serum LNG levels were measured by radioimmunoassay, and sex hormone-binding globulin (SHBG) was quantitated by charcoal assay. On day 1, peak concentrations of LNG (5.1 ng/ml) occurred within 2 hours in the oral group, whereas in the vaginal group a peak of 2.2 ng/ml was reached after 4 hours. After 24 hours, mean serum concentrations of LNG were 1.1 and 0.69 ng/ml in the oral and vaginal groups, respectively. In both groups, mean LNG concentrations increased dramatically on days 7 and 14 compared to day 1. There was no significant difference between the two groups in LNG concentrations, except after 2 hours on day 1. SHBG levels were increased after one day of treatment. By day 14 of treatment, there was a 3.5- to 4.5-fold rise in SHBG levels from pretreatment values in both groups. However, there was no significant difference in SHBG levels between the two groups throughout the study. A high correlation was found between serum levels of SHBG and LNG in both the vaginal and oral groups. The results suggest that the increase in serum LNG levels in women receiving combined contraceptive tablets either vaginally or orally is due to increased levels of SHBG. Also, the measured concentrations of LNG in the vaginal group are consistent with the previously reported clinical contraceptive efficacy of combined contraceptive tablets administered vaginally.

Contraceptives, Oral, Hormonal↗

Contraception for the insulin-dependent diabetic woman: the view from one clinic.

Experience in a large diabetic clinic has confirmed the suspicion that insulin-dependent diabetic women are at considerably increased risk of thromboembolic disease if they take combined estrogen/progestogen oral contraceptive preparations. The most obvious alternative, an intrauterine device, is associated with an unexpectedly high failure rate, probably because of an unusual metabolic interaction with the diabetic endometrium. In a small group of diabetic women the progestogen-only pill was found to be a successful form of contraception not associated with any side effects except for menstrual irregularities. For most diabetic women the choice of contraceptive should therefore be between a progestogen-only pill and a mechanical method. Female sterilization and injectable progesterone each have their place in particular circumstances. Careful counseling of each patient is essential to ensure the best choice of contraceptive and correct application of the chosen method.

Adult↗

Clinical breast and pelvic examination requirements for hormonal contraception: Current practice vs evidence.

Clinical breast and pelvic examinations are commonly accepted practices prior to provision of hormonal contraception. Such examinations, however, may reduce access to highly effective contraceptive methods, and may therefore increase women's overall health risks. These unnecessary requirements also involve ethical considerations and unwittingly reinforce the widely held but incorrect perception that hormonal contraceptive methods are dangerous. This article reviews and summarizes the relevant medical literature and policy statements from major organizations active in the field of contraception. Consensus developed during the last decade supports a change in practice: hormonal contraception can safely be provided based on careful review of medical history and blood pressure measurement. For most women, no further evaluation is necessary. Pelvic and breast examinations and screening for cervical neoplasia and sexually transmitted infection, while important in their own right, do not provide information necessary for identifying women who should avoid hormonal contraceptives or who need further evaluation before making a decision about their use.

Adolescent↗

Evaluating the safety of medicines, with particular reference to contraception.

Toxicological studies and clinical trials cannot be expected to predict all important adverse effects of medicines and contraceptives. Post-marketing surveillance is essentially an epidemiological task that involves detecting associations between drugs and events. The first alerts about drug safety problems have often come from case reports, but epidemiological studies are needed to confirm adverse (or beneficial) effects and to provide quantitative information. This article illustrates methodological principles by considering three examples from the field of contraceptive safety: oral contraceptives and breast cancer, intrauterine contraception and pelvic inflammatory disease, and newer oral contraceptives and venous thromboembolism. Key issues that emerge include bias and confounding, the place of subgroup analyses, random error, and the use of computerized databases. In research on contraceptive and drug safety, conclusions usually need to be based on careful assessment of multiple observational studies.

Bias↗

Chlamydial serologic characteristics among intrauterine contraceptive device users: does copper inhibit chlamydial infection in the female genital tract?

OBJECTIVE: Our objective was to assess the association between copper intrauterine contraceptive device use and the level of antichlamydial antibodies. STUDY DESIGN: Fifty-four women (29 with history of ectopic pregnancy, 2 with non-tubal factor infertility, 1 with tubal factor infertility, and 22 with intact intrauterine pregnancies) with current or prior intrauterine contraceptive device use were compared with 60 prenatal control subjects with respect to antichlamydial antibodies. RESULTS: When the intrauterine contraceptive device user group was subdivided into copper users and Lippes Loop device users, a significantly lower geometric mean serum antibody titer among copper intrauterine contraceptive device users was detected. The odds ratio estimates for past chlamydial exposure (> or = 1:64 immunoglobulin G, > or = 1:128 immunoglobulin G) in users of noncopper versus copper intrauterine contraceptive devices were 9.1 (95% confidence interval 1.9 to 43.0) and 10.5 (95% confidence interval 1.5 to 71.8), respectively. CONCLUSIONS: The lower geometric mean serum antibody titer of antichlamydial antibody among copper versus Lippes Loop device users and the large association measured between past chlamydial infection and noncopper intrauterine contraceptive device use suggest that copper may have a protective effect against Chlamydia trachomatis infection or a suppressive effect on development of antichlamydial antibodies.

Adult↗

Research activity on systemic contraceptive drugs by the U.S. pharmaceutical industry, 1963-1976.

The process of drug development and regulation in the U.S. is first reviewed, with special reference to contraceptives. We next summarize recent data on all pharmaceutical innovation in terms of new chemical entities (NCEs) developed by the U.S.-owned pharmaceutical industry from 1963-1976, and then examine the data on all contraceptive NCEs brought to the stage of clinical investigation by the U.S.-owned firms during that period. Of the 956 NCEs studied in man by 39 U.S.-owned firms, 20 NCEs from ten firms were identified as antifertility agents. Of these, 17 had INDs filed, three of the INDs reached NDA submission, and two of the submissions were approved. Since the mid-1960s there has been a decline in the number of antifertility NCEs taken into human testing anywhere in the world and in the number filed as INDs by U.S. firms. Apart from the approved NDAs, there were only two antifertility NCEs with active INDs at the end of 1976. There have been no marked differences between the oral systemic contraceptive NCEs marketed in the U.S. or Britain since 1963. However, taking both countries together, no true NCE has been introduced for systemic contraceptive use since 1968. Although this study shows declining activity in research on contraceptive NCEs by the U.S. industry, thus supporting to some extent Djerassi's prediction of a decade ago, it should be recognized that it does not include complete data on the research activities in this area by the U.S. government or other non-industrial organizations, or on research sponsored by any group on new contraceptive methods other than NCEs.

Contraceptive Agents↗

Contraceptive use in Vietnam: the effect of individual and community characteristics.

Data from the 1988 Vietnamese Demographic and Health Survey and the 1990 Vietnam Study of Accessibility of Contraceptives were used in this analysis to determine how selective individual and community characteristics influenced the use of modern methods of contraception in Vietnam. Although there were no significant differences in the use of contraceptives between women with a primary education and those with a higher educational attainment, the illiterate women with no formal education were significantly less likely to use modern methods of contraception. Women living in provinces with high infant mortality rates were significantly less likely to use modern methods of contraception than women in low-infant-mortality provinces. Independent of other individual and community characteristics, there were no significant differences in the use of contraception between urban and rural women.

Adolescent↗

The perimenopause and contraception.

OBJECTIVES: To review the implications of pregnancy in women in their forties and the contraceptive options open to them. METHOD: Medline and popline reviews of the literature. RESULTS: Women in their forties are still potentially fertile, and pregnancy in this age group is attended with increased maternal mortality, spontaneous abortion, fetal anomalies and perinatal mortality. In developing countries, these risks are compounded by high parity and poor medical care. Contraception for women in this age group has special risks and benefits, both should be balanced to choose between the different options available. Recent epidemiological and clinical pharmacology studies have indicated the safety of extending the use of combined oral contraceptives (COCs) beyond the age of 35 years and up to menopause. The improved picture of COCs has largely resulted from the use of low-dose-formulations, and avoidance of their use in women with risk factors for developing cardiovascular diseases. Besides their high reliability, which is desirable at this age, COCs will prevent the occurrence of climacteric symptoms and menstrual irregularities which are frequently complained of in the premenopausal years. Moreover, the use of COCs has a substantial protective effect against ovarian and endometrial cancers. Women who have reasons for avoiding COCs can use progestogen-only contraceptives like pills, depot injectables and implants. Norplant combines high efficacy and the long-term effect. Both copper-releasing and levonorgestrel-releasing IUDs (LNG-IUD) combine the advantages of high efficacy and long term effect. The reduced fecundity above the age of forty can allow extending the use beyond the accepted term, and up to one or two years beyond the menopause without the need for replacement. The levonorgestrel IUD has the advantage of reducing the amount of menstrual bleeding. The extent of use of barrier methods will depend upon the availability of a back-up by abortion service in case of failure. The condom has the added benefit of protection against STDs. Male or female sterilization is an excellent contraceptive option, provided that this approach is culturally acceptable and available at reasonable cost and low risk. CONCLUSION: Increasing the number of contraceptive options available to premenopausal women will improve proper counseling and enhance compliance.

Adult↗

Use of the Retinoid Pregnancy Prevention Program in Canada: patterns of contraception use in women treated with isotretinoin and etretinate.

We sought to describe demographic characteristics of and pattern of contraception use by Canadian women prescribed synthetic retinoids who voluntarily contacted the Motherisk Program in Toronto and to describe the degree of use of the Pregnancy Prevention Program (PPP) for retinoids. Prospectively gathered intake data from isotretinoin-exposed women was statistically compared to that from matched controls selected from our database. Intake data is qualitatively reported for etretinate-exposed women. We included women who voluntarily contacted the Motherisk Program from November 1, 1988, to January 30, 1991, for counseling about reproductive risks of isotretinoin or etretinate. Primary outcome parameters were maternal age, race, marital status, socioeconomic status; gravity, parity, previous miscarriages and elective abortions, maternal tobacco and ethanol exposure, contraception use, and use of PPP (educational components used, patient recollection of warnings). The 26 isotretinoin-exposed women were younger than controls (25.2 [SD 6.7] years vs 28.9 [SD 5.1] years, P = 0.03), tended to be adolescent (30.8% vs. 3.8%, P = 0.014) and sought counselling later in gestation (10.1 [SD 8] weeks vs. 6 [SD 4.2] weeks, P = 0.01). Twenty (77%) knew the drug was teratogenic, yet 10 (38.5%) used no contraception, 6 (23.1%) experienced method failure, and 2 (8%) stopped contraception during isotretinoin therapy. In conclusion, although cognizant of the teratogenicity of isotretinoin, more than one-third of the women in this study used no birth control or experienced contraception failure. In this same group, however, compliance with contraception use appeared to increase in those who saw more of the PPP.

Adult↗

Future developments in hormonal contraception.

The range of contraception options has recently increased to include long-term, reversible, and highly effective methods. Several new oral contraceptive (OC) formulations are now available in the United States, where OCs are the most popular reversible method. Long-term contraceptive systems that deliver hormones via subdermal implants, vaginal ring, intrauterine system, and transdermal patch afford convenient and effective alternatives to OCs. Contraceptives using hormone combinations appear to be especially effective with safety profiles comparable to OCs. All recently approved in the United States, the transdermal contraceptive patch offers once-weekly dosing with an improved compliance profile, the monthly vaginal ring has the convenient advantage of being user-controlled; a monthly combination injectable provides good pregnancy protection and improved bleeding control compared with the progestin-only formulatin; and the 5-year the levonorgestrel-releasing intrauterine system significantly diminishes menstrual blood loss. A single subdermal implant has been approved for use in Europe. With 60% of all unintended pregnancies occurring in women using birth control, it is anticipated that this increasing range of options will enhance compliance and provide more effective contraception suitable for the individual user.

Contraceptive Agents, Female↗

Sociocultural and religious influences on the normative contraceptive practices of Latino women in the United States.

Presumably, Latino women engage in little family planning because of religious or cultural objections to contraception. The purpose of this study was to examine how acculturation, religion and various demographic factors were related to the family-planning behaviors of Latino women in the United States. Data were collected on 234 pregnant women (aged 18-40 years), on their family size, how actively they planned their current pregnancy, and how consistently they used contraception in the past. Through path analysis, we found that Spanish-speaking women were more consistent contraceptive users than their English-speaking counterparts, suggesting that acculturation negatively impacts contraceptive use. However, Spanish-speaking women with longer US residency were more likely to be consistent contraceptive users than Spanish-speaking women who had lived in the United States for briefer periods, suggesting a positive effect of acculturation. Religiosity and years of education were associated with family size, but not contraceptive use. Women who were married and had fewer children were more likely to plan their current pregnancy, indicating that Latino women take family size and marital status into consideration when actively deciding to become pregnant.

Acculturation↗

Hormonal contraceptive use and risk of sexually transmitted infections: a systematic review.

Previous research has suggested that hormonal contraceptive users, compared with nonusers, may be at increased risk for acquiring sexually transmitted infections (STIs). We searched the MEDLINE and EMBASE databases for all articles from January 1966 through February 2005 for evidence relevant to all hormonal contraceptives and STIs (including cervical chlamydial and gonococcal infection, human papillomavirus, trichomoniasis, herpes and syphilis). We used standard abstract forms and grading systems to summarize and assess the quality of 83 identified studies. Studies of combined oral contraceptive and depot medroxyprogesterone use generally reported positive associations with cervical chlamydial infection, although not all associations were statistically significant. For other STIs, the findings suggested no association between hormonal contraceptive use and STI acquisition, or the results were too limited to draw any conclusions. Evidence was generally limited in both amount and quality, including inadequate adjustment for confounding, lack of appropriate control groups and small sample sizes. The observed positive associations may be due to a true association or to bias, such as differential exposure to STIs by contraceptive use or increased likelihood of STI detection among hormonal contraceptive users.

Chlamydiaceae Infections↗

[Effect of hormonal contraception on bone mineral density].

Oral contraceptives are used by numerous women very often throughout a prolonged period of time and more and more frequently early in life, within the first reproductive years. The close relationship between oestrogen metabolism and bone turnover raises the question of the potential bone impact of oral contraceptives containing low dose of ethinyl-oestradiol and especially in adolescent girls. During adulthood, most studies have reported that oral contraceptive pills, even those containing a low dose of ethinyl-oestradiol (20 mug), had neutral, or possibly beneficial, effect on bone health. Use of oral contraceptives within the perimenopausal years also would allow to preventing bone loss, given that all vascular and metabolic contra-indications are respected. However, the skeletal effects of oral contraceptives are a greater concern for adolescent girls. Some data suggest that the use of 20 mug pills may impede the development of peak bone mass, particularly when started within the teen years. The bone impact of other hormonal contraceptive methods appears correlated with the degree of suppression of oestrogen levels. There is no effect of low dose progestagen-only pills or progestagen implants on bone health. On the other hand, administration of depot medroxyprogesterone acetate is associated with significant bone loss at all skeletal sites. However, the loss of bone mass might be reversed after discontinuation of use, especially in younger women. The bone impact of progestin only pills that have a strong antigonadotrophinic activity is not currently evaluated although there is some concern about increased bone loss in case of oestrogen deficiency period of long duration.

Adolescent↗