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PubMed1996

Lea's Shield: a study of the safety and efficacy of a new vaginal barrier contraceptive used with and without spermicide.

The purpose of this study was to evaluate the safety, efficacy and acceptability of Lea's Shield, a new vaginal contraceptive barrier device, when used with either spermicidal or non-spermicidal lubricant. One-hundred-eighty-five (185) women enrolled at six centers. Half were randomized to use the device with spermicide and half with a non-spermicidal lubricant. To be eligible, volunteers had to be 18-40 years old (inclusive), in good health with regular menses, sexually active in an ongoing relationship and at risk for pregnancy, and willing to use Lea's Shield as their sole means of contraception for six months. Participants were seen at admission, one week, one month, three months and six months. Gross cumulative life table rates were calculated for pregnancy and others reasons for discontinuation. Adverse experiences and responses to an acceptability questionnaire were evaluated. One-hundred-eighty-two (182) volunteers contributed data to the analysis of safety and 146 to that of contraceptive efficacy. The unadjusted six-month life table pregnancy rate was 8.7 per 100 women for spermicide users and 12.9 for non-spermicide users (p = 0.287). After controlling for age, center, and frequent prior use of barrier methods, the adjusted six-month life table pregnancy rate was 5.6 for spermicide users and 9.3 for non-spermicide users (p = 0.086), indicating that use of spermicide lowered pregnancy rates, although not significantly, during typical use. For purposes of comparison, it is important to note that this study differed from the cap/diaphragm and sponge/ diaphragm studies in that a high percentage (84%) of volunteers were parous. For reasons that are unclear, pregnancy rates among parous women using barrier contraceptives tend to be higher than among nulliparous women. Indeed, in this study there were no pregnancies among nulliparous users of Lea's Shield. Standardization of parity of this study population on those of the cap/diaphragm and sponge/diaphragm studies suggests that unadjusted pregnancy rates for this device would have been considerably lower (2.2 and 2.9 per 100 users of spermicide and non-spermicide, respectively) had the study been done using the populations of earlier studies. Since no directly comparative study has been done, these figures provide a tentative estimate of the relative efficacy of Lea's Shield compared with the sponge, cap, and diaphragm. There were no serious adverse experiences attributed to the use of Lea's Shield. Acceptability was very good. Seventy-five percent (75%) of women responded to an end-of-study questionnaire; 87% of these reported that they would recommend Lea's Shield to a friend. Lea's Shield is a new vaginal contraceptive that does not require clinician fitting. Pregnancy rates in this study compare favorably with other studies of barrier contraceptive methods including the cervical cap, diaphragm, and sponge, even though this study was done with greater rigor and with a greater percentage of parous women than previous barrier studies. Lea's Shield appears to be safe and very acceptable to study volunteers.

Adult↗

PubMed1984

Urinary tract infections among diaphragm users.

An association between diaphragm use and the subsequent development of lower urinary tract infections (urethritis, cystitis, etc) has been suggested by two recent studies in the literature. The present study uses a case-control approach to determine the relative risk of developing urinary tract infections among diaphragm users aged 15 to 45 years during a 15-month period. Patient charts at a family practice clinic were reviewed for evidence of documented urinary tract infections and method of contraception (n = 98). As a control, all women aged 15 to 45 years seen for upper respiratory tract infection during the same period were reviewed (n = 126). Depending upon how a urinary tract infection was defined (urinalysis positive, culture positive, both positive), the relative odds for the development of subsequent urinary tract infections range from 0.88 to 1.10. When all barrier methods were considered together, this odds ratio ranged from 0.88 to 1.21. Documentation of symptoms and laboratory confirmation of urinary tract infection were lacking in many charts reviewed. Despite these limitations, the study findings call into question the assumption that diaphragm use may lead to the subsequent development of urinary tract infection.

Adolescent↗

PubMedDate not supplied

Birth control methods in the United States.

U.S. women have fewer birth control options than do women in other developed countries. Reliance on sterilization helps many couples make up for their lack of choices, but high rates of sterilization among relatively young women are a cause for concern, given the chance of later regret. Although pill use is very high among young women, it falls dramatically among those in their 30s and, often unnecessarily, is minimal among those over 35. The IUD is most appropriate for older women in mutually monogamous relationships who have completed their families, and its availability has been limited in recent years because of liability problems. Although barrier methods are widely used by women of all ages, they are less effective than the pill or IUD. It is fair to conclude that given U.S. women's sometimes long intervals of exposure to the risk of unintended pregnancy, too few safe and effective reversible contraceptives are available in the United States. The addition of an acceptable new method would certainly lead to a reduction in unintended pregnancies, but many potentially useful new methods will not be developed in this century unless the amount of money invested in contraceptive research and development is substantially increased.

Acquired Immunodeficiency Syndrome↗

PubMed1975

Herpes genitalis and circumcision.

214 patients with genital herpes infection proven by culture and a control group of 410 other patients were included in a retrospective study devised to investigate the relationship of circumcision to genital HSV infection in the male. The percentage of patients circumicised in the control group was significantly larger than in the herpes group (P less than 0-01). The was not found to be the case for other sexually-transmitted diseases apart from monilial balanitis. There was also a significant difference in contraceptive methods in the two groups, barrier methods being used less ofter than other methods in the herpes group and the reverse in the control group. It is concluded that there is a positive relationship between absence of circumicision and genital HSV infection, but that a prospective study should be undertaken to confirm these results.

Adult↗

PubMedDate not supplied

[Current status of the female condom in Africa].

The female condom was developed in the 1980s. It is a contraceptive device used by women that protects against both pregnancy and sexually-transmitted diseases (STDs) including HIV infection. Two studies have investigated the contraceptive effectiveness of the female condom, and it was found to be as effective as other barrier methods. It has been shown to be effective against STD and HIV transmission in vitro but there is only limited evidence of its efficacy in vivo. No serious local side effects or allergies have been reported and the female condom can be used with any type of lubricant, spermicidal cream or foam. The female condom is the only device other than the male condom that has been shown to prevent HIV transmission. The female condom has been marketed in 13 countries since the summer of 1996. Most of these countries are industrialized and the selling price in these countries is too high for developing countries. Sub-Saharan Africa has very high prevalence rates for HIV infection, at least 30% of the general population in Eastern and Central regions. The epidemic is also spreading fast in some parts of the Western region. In Ivory Coast for example, 12 to 15% of pregnant women are infected. African women are subordinate to men in many aspects of their lives, politically, educationally, socially and sexually. This sexual inequality makes them highly vulnerable to STDs, including HIV, and unwanted pregnancies. This paper reviews 10 of the 15 studies carried out in sub-Saharan African countries between 1990 and 1996 and compiled by the World Health Organization. Recruitment methods, education of subjects, methodology and assessment of acceptability differed between studies. Despite these limitations, most studies concluded that the women who participated in the trials generally found the female condom acceptable. Acceptability was established quicker among prostitutes than among other women and men found the female condom less acceptable than did women. However, the sample size is too small to draw any firm conclusions. Commercial sex workers in the studies reviewed were very interested in this new method because it gave them an additional method of safer protection during sex. However, they were occasionally faced with difficult negotiations with some clients, refusal to use the female condom and sexual violence. Reuse of the device was reported in four studies, but the term reuse is seldom defined. In cases where it was defined, the frequency of reuse, with washing of the device, accounted for no more than 1% of the total number of uses. The acceptability of the female condom among women other than prostitutes faces two obstacles, the reaction of the woman's regular partner and attitudes to the device itself (appearance, difficulties or uneasiness concerning its use). However, some women liked it because it provided dual protection against pregnancy and STDs and sexual pleasure. The moderate level of acceptability to male partners may be overestimated because women whose partners disliked the device would be more likely to discontinue its use. The studies of acceptability reviewed here show that use of the female condom in Africa is realistic and that it provides women with more independent protection. Initial negative perceptions of the device are often replaced with a more positive reaction after several uses. The experience gained with use reduces the technical problems. We need to overcome the stereotypes, simplifications and strong opinions that threaten to damage the acceptance of this new method and efforts to encourage women to adopt it. However, we still require further clinical data on the effectiveness of the female condom at preventing pregnancy and HIV transmission. Availability of the female condom is improving in Africa. Pilot marketing studies were launched in 1996 in Guinea, Zambia, South Africa, followed by Uganda and Tanzania. There are local initiatives in Ivory Coast and Zimbabwe. (ABSTRACT TRUNC

Africa↗

PubMedDate not supplied

Postcoital test abnormalities in relation to contraceptive use.

Abnormalities of cervical mucus can have a bearing on a woman's fertility. One means of detecting the presence of such abnormalities is the postcoital test (PCT). As part of a population-based case control study of risk factors for infertility, the reproductive, contraceptive, medical, and sexual histories of women seeking treatment for infertility who had abnormal PCT results were compared with those of fertile controls. A greater proportion of infertile women with an abnormal PCT had previously used a diaphragm than had control women (relative risk (RR) = 3.5, 95% CI = 1.1-11.3). The excess risk associated with use of a diaphragm was particularly high for women who had used one for longer than one year (RR = 7.3, 95% CI = 1.4-37.8), or within one year of attempting to conceive (RR = 5.5, 95% CT = 1.4-22.1). No increased risk was associated with the use of other barrier methods, oral contraceptives, or the intrauterine device.

Adult↗

PubMed1986

Bacterial flora of the cervix in women using different methods of contraception.

Bacteriologic culture samples were taken from the cervix in three groups of 10 healthy, sexually active women using barrier contraception, oral contraceptives, or a levonorgestrel-releasing intrauterine contraceptive device. Culture samples for Candida albicans and Trichomonas vaginalis were taken, a cytologic vaginal smear was obtained, and an amine sniff test was performed; these were in addition to a routine gynecologic examination. Multiple bacteria were isolated from the cervix in women using oral contraceptives or an intrauterine contraceptive device, whereas lactobacilli alone dominated the flora of women using barrier contraception. Significantly more anaerobic bacteria were isolated from the cervix in oral contraceptive and intrauterine contraceptive device users when compared with the barrier method users. Symptoms and findings evident of anaerobic vaginosis were associated with the occurrence of anaerobic bacteria in the cervix of three patients using the intrauterine contraceptive device. The results showed that the cervical bacterial flora in sexually active healthy women is rich in anaerobes that can be regarded as a normal finding in women using oral contraceptives or intrauterine contraceptive devices. Barrier contraception with a condom prevents this anaerobic shift and maintains a lactobacilli-dominated flora in the cervix.

Adolescent↗

PubMed1996

Contraception in the 1990s.

Contraceptive technology has recently provided the market place with new barrier methods, new progestin oral contraceptives, an injectable contraceptive, the female condom, new male condoms, and the contraceptive implant. During the last decade, epidemiologists have clearly defined the non-contraceptive benefits of current contraceptive methods that include decreased infections, protection from various cancers, protection from many gynecologic problems that lead to surgery, as well as symptomatic relief from many gynecologic conditions. In conjunction with medical specialists, contraceptive researchers have established the increased safety and benefits of various contraceptive choices in women with medical conditions that, until recently, were contra-indications for their use. That these advances have occurred despite multiple legal and scientific assaults gives hope that the field will continue to grow.

Contraception↗

PubMed1986

Parity and use-effectiveness with the contraceptive sponge.

The results of a randomized United States study indicated that the Today contraceptive sponge was less effective than the diaphragm (1-year cumulative life-table rate of 17.4 versus 12.9 pregnancies per 100 women, p = 0.01). However, this overall comparison is misleading. Using univariate and multivariate analyses to account for the effects of user characteristics we found parity to be the most important single determinant of effectiveness for users of the sponge, but parity was unimportant as a risk factor for pregnancy among diaphragm users. For nulliparous women the sponge was as effective as a physician-prescribed barrier method (13.9 for sponge, 12.8 for diaphragm, p = 0.45); however, parous women using the sponge were twice as likely to become pregnant (28.3 for sponge, 13.4 for diaphragm, p = 0.001). The effect of parity among sponge users is consistent with the results of international studies of the contraceptive sponge.

Adult↗

PubMed1997

Teaching about the female condom.

Reality female condoms became available for over-the-counter purchase in the fall of 1994. Because the female condom is a new sexual barrier device, women need to learn how to use it correctly. Health care providers must also be knowledgeable about the correct use of the female condom so that they can teach women how to use it as a barrier method. To facilitate learning about the female condom, a curriculum was developed that included a quiz on knowledge about the female condom. Content validity was established through a content validity index completed by six content experts. This quiz was used to evaluate educational sessions offered to 42 persons in an urban college setting and 18 women in a community setting. The article describes the female condom along with the curriculum that was developed to teach its correct use and the reactions of potential users of the female condom.

Adult↗

PubMed1999

Heterosexual men's attitudes toward the female condom.

This article addresses heterosexual men's familiarity with the female condom and their attitudes toward this barrier method. Qualitative interviews were conducted with 71 ethnically diverse and heterosexually active men who were recruited in sexually transmitted disease (STD) clinics or through word of mouth in communities with high HIV/STD seroprevalence in New York City during fall 1994 to fall 1995. Only one man reported previous experience with the female condom. The large majority of men had no or limited knowledge of the female condom. Men's reactions to learning about this method ranged from positive to negative, although most men reported willingness to have sex with a partner who wanted to use the female condom. Positive reactions included: endorsement of a woman-controlled condom and her right to use it, the potential for enhancing one's sexual pleasure, and an eagerness to have a new sexual experience. Negative reactions centered on the "strangeness" and "bigness" of the female condom, concerns about prevention efficacy, and concerns about reductions in sexual pleasure. Our findings highlight the need for HIV prevention programs that target heterosexual men and promote the use of the female condom.

Adult↗

PubMed2000

Predictors of female condom use among women exchanging street sex in New York City.

BACKGROUND: Alternative female-initiated barrier methods, such as the female condom, are needed among women exchanging street sex to enhance their ability to protect themselves from HIV and STD infection. OBJECTIVE: To describe predictors of female condom use among 96 women exchanging sex for money and drugs on the streets of New York City. STUDY DESIGN: A total of 113 sex workers received a baseline interview, a demonstration on proper female condom use, and 10 female condoms. A total of 101 sex workers received a followed-up evaluation at 2 weeks, of which 96 were included in data analysis. Predictors of condom use were analyzed for (1) any type of use; and (2) use with commercial partners. RESULTS: The strongest predictors of female condom use among this sample of sex workers were (1) living with someone with a drug or alcohol problem; (2) having heard of the female condom; and (3) homelessness. Current physical or sexual abuse by a commercial partner and marriage decreased the probability of female condom use. CONCLUSIONS: Female condom distribution encouraged sex workers who may be most vulnerable or who reported characteristics or behaviors associated with the highest sexually transmitted disease and HIV risk to try female condoms with commercial partners. Implications for intervention development include the need to develop innovative programs provided on the street (e.g., through peers) that can access homeless, drug-using sex workers in the most at-risk environments.

Adult↗

PubMed2000

Male-condom and female-condom use among women after counseling in a risk-reduction hierarchy for STD prevention.

BACKGROUND: A concern with hierarchy messages, which promote male condoms and female-controlled barrier methods along a prevention continuum, is that they may discourage condom use. GOAL: To measure male-condom and female-condom use among women who received hierarchy counseling and compare this with women counseled about condoms only. STUDY DESIGN: Three observational cohorts that correspond to prevention message received were assembled, and consisted of female sexually transmitted disease clinic patients who were counseled about male condoms, female condoms, or a hierarchy message. The hierarchy message promoted male and female condoms, the diaphragm and cervical cap, spermicides, and withdrawal, in descending order of effectiveness against sexually transmitted diseases. After counseling, women were interviewed and returned for follow-up visits at 2 weeks, 4 months, and 6 months. The outcome was the mean proportion of male condom- or female condom-protected coital acts at each follow-up visit in the hierarchy cohort. The outcome was dichotomized as high (> or = 70% of coital acts protected) or low (< 70%), and generalized estimating equations were used to compare observed follow-up condom use with baseline within the hierarchy cohort and observed follow-up condom use between cohorts. It was assumed that condom use in persons not present at 6 months was equal to baseline levels, and condom use estimates were calculated for each full cohort that was initially enrolled.

Cohort Studies↗

PubMed1993

Contraception choice and sexually transmitted disease.

Sexually active couples need to be concerned with the risk of sexually transmitted diseases (STDs) and how their choice of contraception influences that risk. Condoms provide the best documented protection against such pathogens as: gonorrhea, herpes simplex virus (HSV), hepatitis B, HIV, and chlamydia. Female dependent barrier methods also provide protection against most STDs and also possibly HIV. Most hormonal non-barrier contraceptives, although providing excellent protection against unwanted pregnancies, provide little protection against STDs. Oral contraceptive pills (OCP) may increase the risk of infection with human papillomavirus (HPV) and cervical infections of chlamydia. Individuals at high risk for both an unwanted pregnancy and an STD should be counseled to use both a hormonal and barrier contraceptive. Recently, nonoxynol-9 (N-9) and OCP use have been associated with an increase in HIV infection in African women at high risk for HIV. This association has not been found in other studies and currently does not outweigh the proven benefits of these contraceptive methods.

Choice Behavior↗

PubMed1984

A prospective controlled study of the effect on blood pressure of contraceptive preparations containing different types and dosages of progestogen.

A prospective controlled study investigated the effects of oral contraceptives on blood pressure in 485 women who were between 17 and 46 years of age and had blood pressures of less than 140/90 mmHg at entry. The women were divided into seven groups depending on the chosen method of contraception: intrauterine device or barrier method (control group): ethinyl oestradiol 30 micrograms plus levonorgestrel 150 micrograms (Microgynon-30 or Ovranette); norethisterone 350 micrograms (Micronor); norgestrel 75 micrograms (Neogest); norethisterone oenanthate 200 mg intramuscularly every 2 months for the first 6 months, then every 3 months thereafter; ethinyl oestradiol 30 micrograms plus ethynodiol diacetate 2 mg (Conova-30); and ethynodiol diacetate 500 micrograms (Femulen). Blood pressures were measured every 3 months by the family planning clinic nurse under standardized conditions using an Elag-Köln automatic sphygmomanometer. After one year, blood pressure had risen significantly (P less than 0.05) in the 137 women taking ethinyl oestradiol plus levonorgestrel (mean systolic and diastolic rises 6.4 and 2.7 mmHg respectively) and in the 91 women taking ethinyl oestradiol plus ethynodiol diacetate (mean systolic and diastolic rises 6.2 and 3.0 mmHg respectively). The 94 women taking the progestogen-only preparations and the 143 women in the control group showed no increases in blood pressure. These data were confirmed after 2 years of follow-up.

Adolescent↗

PubMed1985

Contraceptive usage during lactation: analysis of 1973 and 1976 National Survey of Family Growth: I. Age and race.

Data from the National Survey of Family Growth are analyzed to estimate the prevalence of contraceptive use during lactation. Approximately 20 per cent of lactating women were sexually active and did not use a method in months two through six, postpartum. Among method users, the largest proportion chose barrier methods but 14 per cent used oral contraceptives in the early postpartum period. Between 1973 and 1976 there was an increase in the percentage of women who utilized a contraceptive method during lactation and a decrease in the per cent using oral contraceptives.

Adolescent↗

PubMed1980

Contraception in the adolescent: current concepts for the pediatrician.

An overview is presented of the major methods of contraception available to the sexually active adolescent. Emphasis is given to the combined birth control pill, while the literature describing absolute and relative contraindications to oral contraception is reviewed. It is noted that adolescents with chronic illness must also be evaluated for contraceptive needs. Other methods covered include the intrauterine device, barrier methods (diaphragm, condom, and vaginal contraceptives), injectable contraceptives, postcoital contraception, and methods under current investigation. The approach to each patient must be individualized, based on her coital activity, understanding of alternatives, medical status, and what method is chosen.

Adolescent↗

PubMedDate not supplied

Contraceptive use in Canada, 1984.

Canada's first national fertility survey, carried out by telephone in 1984, found that 68 percent of all women aged 18-49-73 percent of currently married women, 69 percent of the previously married women and 57 percent of single women--are practicing contraception. Overall, the most widely used method of birth control in Canada is sterilization (male and female), which is relied on by almost 60 percent of all married users and 66 percent of previously married users. Among single women, the preferred method is the pill, chosen by seven out of 10 of such users. Among all women, the major determinant of method choice is age: The pill is overwhelmingly chosen by women under 25, and sterilization, by those 30 and over. While the IUD and the condom are used by roughly 10-14 percent of women in their 20s who practice contraception, these methods decline in importance with increasing age. Highly educated women are less likely than those with little education to elect sterilization, and more likely to rely on barrier methods. Differences in contraceptive prevalence and patterns of use between Catholics and Protestants have all but disappeared in Canada, but church attendance and country of birth appear to exert a modest influence on method choice. As might be anticipated, women whose family size is complete have considerably higher levels of contraceptive use than those who expect to have more children. The survey reveals no difference in contraceptive use between Quebec women and those in the rest of Canada, thus confirming both the accuracy of earlier Quebec studies showing extremely high levels of sterilization and the applicability of these findings to all other Canadian women.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗