Diagnosis and treatment of presumed STIs at Mexican pharmacies: survey results from a random sample of Mexico City pharmacy attendants.

OBJECTIVES: People in developing countries often seek medical advice for common ailments from pharmacies. As one example, pharmacists routinely diagnose and treat symptomatic sexually transmitted infections (STIs). We aimed to assess the quality of advice provided in Mexico City pharmacies by presenting hypothetical STI related syndromes and recording pharmacy attendants' suggested diagnoses and treatments. METHODS: We interviewed the first available attendant in each of a 5% random sample of Mexico City's pharmacies. We inquired about the training, age, and experience of the attendant and about the typical number of clients coming for treatment of suspected STIs. After considering three hypothetical case studies, attendants recommended diagnoses, treatments, and, sometimes, physician follow up. RESULTS: Most Mexico City "pharmacists" are actually clerks, with trained pharmacists rarely available on the premises. The average pharmacy attendant was 32 years old, with a median of 5 years' experience at that pharmacy, but very limited (if any) training. 62% reported seeing 10 or more clients with genital or vaginal infections per month. Depending on the case study, attendants provided appropriate diagnoses in 0-12% of cases, recommended appropriate treatments in 12-16% of cases, and suggested physician follow up for 26-67% of cases. CONCLUSIONS: In general, surveyed pharmacy personnel were unable to diagnose accurately or offer appropriate treatment advice when presented with classic, common STI symptoms. Given the volume of clients seeking advice from this source, training pharmacy attendants could significantly help to reduce the burden of disease associated with STIs in Mexico City.

Emergency contraception.

Emergency contraceptives are methods that prevent pregnancy when used shortly after unprotected sex. Three different emergency contraceptive methods are safe, simple, and widely available in the United States. These are: (1) ordinary combined oral contraceptives containing ethinyl estradiol and levonorgestrel taken in a higher dose for a short period of time and started within a few days after unprotected intercourse; (2) levonorgestrel-only tablets used similarly; and (3) copper-bearing intrauterine devices inserted within approximately 1 week after unprotected intercourse. Emergency contraceptive use is best known for women who have been raped, but the methods are also appropriate for women who have experienced condom breaks, women who did not use any method because they were not planning on having sex, or women who had unprotected intercourse for any other reason. Unfortunately, few women know about emergency contraceptives, and few clinicians think to inform their patients routinely about the option. A nationwide toll-free hotline (1-888-NOT-2-LATE) and a website (http://not-2-late.com) can help women learn about these options. Sharing "family planning's best-kept secret" widely with women could prevent as many as a million unwanted pregnancies annually in the United States.

Acceptability and feasibility of Micralax applicators and of methyl cellulose gel placebo for large-scale clinical trials of vaginal microbicides.

OBJECTIVE(S): To evaluate the feasibility and acceptability of the Micralax applicator and of methyl cellulose placebo gel for use in vaginal microbicide clinical trials. DESIGN: A two-centre prospective study following women for 2 months. SETTING: Two primary health care clinics in South Africa. PATIENTS, PARTICIPANTS: Female volunteers (n = 28) 18 years or older who were HIV negative and had no clinically detectable genital tract abnormalities or reproductive tract infections. INTERVENTIONS: Participants used pre-filled Micralax applicators to apply methyl cellulose gel every other day, as well as up to 1 h before to every episode of vaginal sex. MAIN OUTCOME MEASURE(S): Consistency in the weight of gel dispensed per application; side-effects attributed to applicator or gel use; and acceptability of the applicator and of the gel. RESULTS: Over a 2 month follow-up period the 22 women completing the study reported no adverse events related to gel or applicator use. The Micralax applicator proved acceptable. The gel was not too messy and did not reduce sexual frequency or pleasure. On average, the applicator dispensed 4.7 ml per use (close to the 4 ml planned). CONCLUSIONS: The Micralax applicator performs well as a delivery system for potential vaginal microbicides; and methyl cellulose is an appropriate placebo for future microbicide trials.

Women's willingness to participate in microbicide trials in Northern Thailand.

To assess women's interests and concerns regarding participation in trials of microbicides in Chiang Rai, Thailand, we administered structured questionnaires. Before answering the questionnaire, women attended an educational session on microbicides and clinical trials. Of 370 participants, 82% correctly answered 8 or more of the 11 overall comprehension questions, indicating an adequate knowledge base among the women from which to answer questions about attitudes toward microbicide trials. The most common motivations for participating in a trial were "getting tested for HIV" and "doing something good for women's health." The greatest barrier to participation was women's fear that if they proposed use of a microbicide, their husbands might feel protected and thereby have more sex partners. Overall, 6.2% said they would be "definitely willing to participate," and 66.8% said they wanted to participate but wanted to think about it. Most women previously unacquainted with the concept of microbicides or clinical trial design displayed adequate knowledge of these subjects after the short educational session. If women's initial reactions are validated by actual willingness, surveys could prove valuable for selecting sites for microbicide trials, estimating enrollment rates, and tailoring trials to make them most acceptable to women.

Emergency contraception: randomized comparison of advance provision and information only.

OBJECTIVE: To determine whether multiple courses of emergency contraceptive therapy supplied in advance of need would tempt women using barrier methods to take risks with their more effective ongoing contraceptive methods. METHODS: We randomly assigned 411 condom users attending an urban family planning clinic in Pune, India, to receive either information about emergency contraception along with three courses of therapy to keep in case of need, or to receive only information, including that about the locations where they could obtain emergency contraception if needed. For up to 1 year, women returned quarterly for follow-up, answering questions about unprotected intercourse, emergency contraceptive use, pregnancies, sexually transmitted infections, and acceptability. RESULTS: Women given advance supplies reported unprotected intercourse at rates nearly identical to those among women given only information (0.012 versus 0.016 acts per month). Among those who did have unprotected intercourse, however, supply recipients were nearly twice as likely (79% versus 44%) to have taken emergency contraception, although numbers were too small to permit statistically significant inferences. No women used emergency contraception more than once during the study, even though everyone in the advance-supplies group had extra doses available. All women found knowing about emergency contraception useful, and all those receiving only information wished they had received supplies as well. CONCLUSION: Multiple emergency contraception doses supplied in advance did not tempt condom users to risk unprotected intercourse. After unprotected intercourse, however, those with pills on hand used them more often. Women found advance provision useful.

Can women in less-developed countries use a simplified medical abortion regimen?

BACKGROUND: Mifepristone-misoprostol abortion, consisting of oral pills, is potentially simple and safe enough for use in less-developed countries. But the labour-intensive, costly, clinic-based European protocols are not affordable or feasible in most less-developed countries. METHODS: We prospectively tested two simplifications to the French mifepristone-misoprostol regimen in Vietnam and Tunisia. Women (n=315) with amenorrhoea 8 weeks or less since their last menstrual period received 200 mg mifepristone in the clinic and then chose whether to take 400 mg oral misoprostol 2 days later either at home or in the clinic. FINDINGS: Despite the two-thirds reduction in mifepristone dose, success rates were high: Vietnam 93%, Tunisia 91%. About 88% of participants chose home administration of misoprostol. Most Vietnamese and Tunisian women were satisfied with their abortions, but efficacy and satisfaction rates were higher among those who used misoprostol at home. INTERPRETATIONS: A simplified medical abortion regimen of 200 mg mifepristone followed by the option of home administration of misoprostol seems feasible.

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.

Mifepristone abortion outside the urban research hospital setting in India.

Medical abortion holds great promise in less-developed countries, where abortion morbidity and mortality remain high. We tested the French mifepristone-misoprostol regimen in two urban outpatient family-planning clinics (n=600) and a rural hospital (n=300) in India. 4% of urban women and 1% of rural women were lost to follow-up. Perfect use and typical-use success rates were as high as European rates at all sites. Although rural women reported fewer side-effects, most women in urban and rural settings were satisfied with their medical abortions. Medical abortion can be offered safely, effectively, and acceptably in urban outpatient clinics and rural hospitals in India.

The mifepristone-misoprostol regimen for early medical abortion.

The combination of mifepristone, an antiprogesterone known in the United States as Mifeprex (Danco Laboratories, New York, NY), and misoprostol, a prostaglandin analogue marketed in the United States under the brand name Cytotec (Pharmacia [formerly Searle], Peapack, NJ), provides a nonsurgical abortion in the early stages of a pregnancy. Mifepristone blocks the action of progesterone, a hormone necessary to sustain a pregnancy, whereas misoprostol causes contractions that expel the embryo and other pregnancy tissue. Since September 2000, mifepristone has been approved by the United States Food and Drug Administration for induced abortions of gestations of 49 days or less since the last menstrual period, but is not yet approved for any other uses. Misoprostol has long been approved to prevent and treat stomach ulcers.

Vaginal misoprostol administered 1, 2, or 3 days after mifepristone for early medical abortion: A randomized trial.

CONTEXT: The conventional timing of misoprostol administration after mifepristone for medical abortion is 2 days, but more flexible intervals, which may make the regimen more convenient, have not been studied. OBJECTIVE: To determine whether vaginal misoprostol administered 1, 2, or 3 days after mifepristone influences safety or effectiveness for abortion at up to 56 days' gestation. DESIGN: Prospective, randomized, open-label trial conducted from March 1998 to June 1999. SETTING: Sixteen US primary care and referral abortion facilities. PATIENTS: A total of 2295 healthy patients aged 18 years or older who were 56 or fewer days pregnant. Forty (1.7%) were lost to follow-up. INTERVENTIONS: Patients received 200 mg of oral mifepristone and were randomly assigned to self-administer 800 microg of vaginal misoprostol at home 1 (n = 745), 2 (n = 778), or 3 (n = 772) days later. Women returned to the clinic up to 8 days after mifepristone for ultrasonographic evaluation. A second dose of misoprostol was administered if the abortion was not complete. Patients with continuing pregnancy, excessive bleeding, or retained pregnancy tissue 5 weeks later received an aspiration curettage. MAIN OUTCOME MEASURES: Effectiveness of the procedure (ie, a complete medical abortion without surgical intervention), adverse effects, acceptability of the procedure based on patient questionnaires, reasons for surgical intervention, and adverse outcomes, compared among the study groups. RESULTS: Of the 2255 women completing follow-up, complete medical abortion rates were 98% (95% confidence interval [CI], 97%-99%) among those using misoprostol after 1 day, 98% (95% CI, 97%-99%) for those using misoprostol after 2 days, and 96% (95% CI, 95%-97%) among those using misoprostol after 3 days. Fifty-five subjects aborted before taking misoprostol, 9 had early surgery, and 103 did not take misoprostol on their assigned day. No blood transfusions were required. Cramping and nausea were the most common adverse effects reported, with similar percentages of patients in all 3 groups reporting such effects. Thirteen unexpected or serious adverse events occurred: 6 in those using misoprostol after 1 day; 4 in those using it after 2 days; and 3 in those using it after 3 days. Nearly all women (>90%) found the procedure to be acceptable. CONCLUSIONS: Our results suggest that vaginal misoprostol, 800 microg, can be used from 1 to 3 days after mifepristone, 200 mg, for early medical abortion, and need not be administered strictly 48 hours after mifepristone. JAMA. 2000;284:1948-1953.

What do family planning clients and university students in Nairobi, Kenya, know and think about emergency contraception?

Currently, emergency contraception is seldom used in Kenya. As part of a larger study designed to provide insight into the possible roles for the method in Kenya, we assessed the knowledge of and attitudes towards emergency contraception in two groups of potential users, and we focus on these data specifically in this paper. We interviewed clustered samples of clients at ten family planning clinics in Nairobi (n = 282) and conducted four focus group discussions with students at two universities in Kenya (n = 42). Results show that despite relatively low levels of awareness and widespread misinformation, when the method was explained, both clients and students expressed considerable interest, but also expressed some health and other concerns.

Is medical abortion acceptable to all American women: the impact of sociodemographic characteristics on the acceptability of mifepristone-misoprostol abortion.

OBJECTIVE: To determine whether mifepristone-misoprostol medical abortion is more acceptable to some American women than to others. METHODS: Using previously reported acceptability data from a large US multicenter study (n = 2121), we conducted a more detailed analysis to test whether characteristics such as race/ethnicity, education, age, gestational age, and geographic location affect acceptability. RESULTS: In the United States, Asian women were more than twice as likely as other women to choose this method because they believed it was safer, while white women were twice as likely to select it because they considered it more natural. More educated women were likely to select this method to show support for greater choice and were more pleased about being able to avoid surgery. Particular features of the protocol also appealed to different women. White and African-American women as well as women with more education would feel significantly more comfortable taking one or both of the drugs at home than they would in the clinic. Nearly all groups of women were equally satisfied with this method and found it highly acceptable. The data showed surprisingly few differences among women's overall satisfaction level, their willingness to choose the method again, or to recommend it to others. CONCLUSION: Mifepristone-misoprostol medical abortion has widespread appeal to a broad range of women, but different women choose and prefer this method for different reasons.

[Emergency contraception: a simple, safe, effective and economical method for preventing undesired pregnancy]. / Anticoncepción de emergencia: un método simple, seguro, efectivo y económico para prevenir embarazos no deseados.

In the following article, the most recent knowledge on emergency contraception (EC) is reviewed. EC is defined as those contraceptive methods that may be used to prevent an unwanted pregnancy up to 3 days after unprotected intercourse, contraceptive failure or rape. In case of non-hormonal methods (IUD), the time window for pregnancy prevention goes up to 5 days after intercourse. The different regimens now available, hormonal and non-hormonal methods, indications, contraceptive effectiveness, side effects and safety profile, possible mechanisms of action and counseling strategies will be reviewed. The potential benefits on reproductive health of wide-spread knowledge and easy, non-restrictive access to this methodology are emphasized. An extensive list of recent references is enclosed.

Emergency contraception: a review of the programmatic and social science literature.

Many biomedical aspects of emergency contraception have been investigated and documented for >30 years now. A large number of social science questions, however, remain to be answered. In this article, we review the rapidly growing but geographically lopsided literature on this topic. Using computer database searches supplemented by reference reviews and professional correspondence with those active in the field, we gathered literature on the social science and service delivery aspects of emergency contraception published in English up through December 1998, as well as a few unpublished papers from the same time and slightly later, representing regions where published material is practically nonexistent. Methodologically acceptable papers are summarized in our tables and text, and form the basis for suggested improvements in existing emergency contraceptive services. The review also offers ideas for designing new emergency contraception services where they do not yet exist. We conclude by proposing an agenda for further social science research in this area.

Preliminary safety and acceptability of a carrageenan gel for possible use as a vaginal microbicide.

OBJECTIVE: We sought to determine the safety and acceptability of vaginal gel formulation PC-503 among low risk, abstinent women. The active ingredient was 2% pharmaceutical grade lambda carrageenan, a sulphated polymer that is generally recognised as safe by the US Food and Drug Administration. METHODS: 35 women in five sites applied 5 ml of the PC-503 gel vaginally once a day for 7 days while abstaining from sexual intercourse. Visual vaginal examinations were performed on days 1, 4, and 8. STI testing and vaginal pool Gram stain preparations were done on days 1 and 8. Participants were asked about product acceptability. RESULTS: 34 of the 35 women enrolled completed 7 days' use. Following product use, five reported mild symptoms including "bladder fullness," "genital warmth," or discomfort, and lower abdominal pain, and one had moderate pale yellow cervical discharge. Using the Nugent criteria, three women had bacterial vaginosis (BV) before and after use; three had BV before but not after, and two had BV after but not before. Most of the women found PC-503 to be pleasant or neutral in feel and smell and considered extra lubrication to be an advantage; however, one third found it to be messy. CONCLUSIONS: Vaginal use of PC-503 gel did not cause significant adverse effects in a small number of low risk, sexually abstinent women. Further testing in larger numbers of sexually active women is planned. A smaller volume of gel may be more acceptable to some women.

Accuracy of assessment of pregnancy duration by women seeking early abortions.

BACKGROUND: Advances in medical abortion might allow women seeking early abortions to terminate their pregnancies safely and effectively without medical supervision. We investigated whether such women can calculate pregnancy duration accurately, a key step in unsupervised use. METHODS: 422 women seeking first-trimester abortions in two clinics (Pune, India, and Atlanta, USA) used a simple worksheet and calendar to calculate the duration of gestation from the date of last menstrual period (LMP) and/or of unprotected intercourse. Clinicians then used standard clinic practices to estimate pregnancy duration. We compared the two sets of estimates, focusing on women who fell into the "caution zone" (ie, had pregnancy durations >8 weeks according to providers, but < or =8 weeks by their own estimates). FINDINGS: The participants were generally representative of the women seeking abortion at the two clinics. 217 (97.7%) of 222 women in Atlanta and 173 (86.5%) of 200 in Pune could produce an estimate of pregnancy duration. Most (85.4% in Atlanta; 93.6% in Pune) of these estimates were within 2 weeks of those made by providers. For estimates based on LMP, only 10.0% (exact 95% CI 6.2-15.0) of women in Atlanta and 9.8% (5.8-15.3) in Pune fell into the caution zone. For estimates based on a date of intercourse, just 7.7% (4.0-13.1) of women in Atlanta and 3.4% (0-17.8) in Pune fell into the caution zone, although fewer women could use this method. INTERPRETATION: The vast majority of women seeking first-trimester abortion in this study could accurately calculate pregnancy duration within a margin of error clinically inconsequential for safe use of unsupervised medical abortion.

Misoprostol used alone for the termination of early pregnancy. A review of the evidence.

Increased access to medical methods of abortion could significantly reduce maternal mortality, especially in developing countries. In light of the political and commercial difficulties in distributing the abortifacient mifepristone, the widely studied mifepristone-misoprostol regimen may not be sufficiently available in the near future. Thus, researchers have begun to look for alternative regimens, including regimens using misoprostol alone. This article reviews the current available evidence on the potential of a misoprostol-alone regimen for medical abortion. Although the data are varied and difficult to compare, recent studies indicate that a misoprostol-alone regimen could be safe and effective as a method of medical abortion. Misoprostol is widely marketed around the world for its other indications and is inexpensive, stable in tropical climates, easy to transport, and simple to administer. A misoprostol-alone regimen of medical abortion could thus greatly improve the access to safe medical abortion services by women in developing countries.

PIP: Studies have been conducted to examine the potential of misoprostol alone for early termination of pregnancy. These studies were done by Norman et al. (1991), Creinin and Vittinghoff (1994), Bugalho et al. (1996), Koopersmith and Mishell (1996), Carbonell et al. (two studies: 1997, 1998), and Jain et al. (1998). The designs, population sampling methods and regimens varied from study to study. Thus, comparison of results has been difficult. Overall, though, findings indicate that a misoprostol-alone regimen could be safe and effective as a method of medical abortion. This regimen could greatly improve access to safe medical abortion services for women in developing countries, which in turn would lead to a significant reduction in maternal mortality.