Comparative satisfaction of receiving medical abortion service from nurses and auxiliary nurse-midwives or doctors in Nepal: results of a randomized trial.

BACKGROUND: Early first-trimester medical abortion (MA) service (≤ 63 days) has been provided by doctors and nurses under doctors' supervision since 2009 in Nepal. This paper assesses whether MA services provided by specifically trained and certified nurses and auxiliary nurse-midwives independently from doctors' supervision, is considered as satisfactory by women as those provided by doctors. METHODS: The data come from a multi-center, randomized, controlled equivalence trial conducted between April 2009 and March 2010 in five district hospitals in Nepal. Women seeking MA were randomly assigned to doctors or nurses and auxiliary nurse-midwives(ANMs).Eligible women were administered 200 mg mifepristone orally followed by 800 µg misoprostol vaginally two days later by their assigned providers and followed up 10-14 days later. At the follow-up visit women's reported satisfaction with MA service they received was measured. RESULTS: Of 1295 women screened for eligibility, 535 were randomly assigned to a doctor and 542 to a nurse or ANM. Nineteen women were lost-to-follow up in the former group and 27 were lost-to-follow up or did not complete the acceptability interview in the latter group. This study is, therefore, based on516womenin the doctor's group and 515 women in the nurse or ANM group. All women in the nurse or ANM group reported being satisfied or highly satisfied by MA compared to 99% in the doctor's group. Satisfaction was similar regardless of the type of provider; 38% among nurse or ANM and 35% among the doctor group were "highly satisfied", and 62% and 64%, respectively, were "satisfied". Women's experiences such as 'less than expected amount or duration of bleeding following MA', 'shorter than expected duration of the abortion process', and 'able to manage symptoms', were found to be associated with women's higher satisfaction with MA. Counseling and information on the method, potential complications of MA and post-abortion contraception was nearly universal. No statistically significant differences were found in the level of satisfaction by age, parity, marital status, education or occupation of women. CONCLUSIONS: Women's satisfaction with MA service provided by trained nurses or auxiliary nurse-midwives was similar to that provided by doctors. The findings, therefore, provide support for extending safe and accessible medical abortion services by government-trained nurses and auxiliary nurse midwives to women seeking early first trimester pregnancy termination. TRIAL REGISTRATION: The trial was retrospectively registered with ClinicalTrials.gov (identifier: NCT01186302 ). Registered August 20, 2010.

Two mifepristone doses and two intervals of misoprostol administration for termination of early pregnancy: a randomised factorial controlled equivalence trial.

OBJECTIVE: To compare the efficacy of 100 mg and 200 mg of mifepristone and 24- and 48-hour intervals to administration of 800 microg vaginal misoprostol for termination of early pregnancy. DESIGN: Placebo-controlled, randomized, equivalence trial, stratified by centre. SETTING: 13 departments of obstetrics and gynecology in nine countries. POPULATION: 2,181 women with 63 days or less gestation requesting medical abortion. METHODS: Two-sided 95% CI for the risk differences of failure to complete abortion were calculated and compared with 5% equivalence margin between two doses of mifepristone and two intervals to misoprostol administration. Proportions of women with adverse effects were compared between the regimens using standard testes for proportions. OUTCOME MEASURES: Rates of complete abortion without surgical intervention and adverse effects associated with the regimens. RESULTS: Efficacy outcome was analysed for 2,126 women (97.5%) excluding 55 lost to follow up. Both mifepristone doses were found to be similar in efficacy. The rate of complete abortion was 92.0% for women assigned 100 mg of mifepristone and 93.2% for women assigned 200 mg of mifepristone (difference 1.2%, 95% CI: -1.0 to 3.5). Equivalence was also evident for the two intervals of administration: the rate of complete abortion was 93.5% for 24-hour interval and 91.7% for the 48-hour interval (difference -1.8%, 95% CI: -4.0 to 0.5). Interaction between doses and interval to misoprostol administration was not significant (P = 0.92). Adverse effects related to treatments did not differ between the groups. CONCLUSIONS: Both the 100 and 200 mg doses of mifepristone and the 24- and 48-hour intervals have a similar efficacy to achieve complete abortion in early pregnancy when mifepristone is followed by 800 micrograms of vaginally administered misoprostol.

Rates of complication in first-trimester manual vacuum aspiration abortion done by doctors and mid-level providers in South Africa and Vietnam: a randomised controlled equivalence trial.

BACKGROUND: We assessed whether the safety of first-trimester manual vacuum aspiration abortion done by health-care providers who are not doctors (mid-level providers) is equivalent to that of procedures done by doctors in South Africa and Vietnam, where mid-level providers are government trained and accredited to do first-trimester abortions. METHODS: We did a randomised, two-sided controlled equivalence trial to compare rates of complication in abortions done by the two groups of providers. An a-priori margin of equivalence of 4.5% with 80% power and 95% CI (alpha=0.05) was used. 1160 women participated in South Africa and 1734 in Vietnam. Women presenting for an induced abortion at up to 12 weeks' gestation were randomly assigned to a doctor or a mid-level provider for manual vacuum aspiration and followed-up 10-14 days later. The primary outcome was complication of abortion. Complications were recorded during the abortion procedure, before discharge from the clinic, and at follow-up. Per-protocol and intention-to-treat analyses were done. This trial is registered at with the identifier . FINDINGS: In both countries, rates of complication satisfied the predetermined statistical criteria for equivalence: rates per 100 patients in South Africa were 1.4 (eight of 576) for mid-level providers and 0 for doctors (difference 1.4, 95% CI 0.4 to 2.7); in Vietnam, rates were 1.2 (ten of 824) for mid-level providers and 1.2 (ten of 812) for doctors (difference 0.0, 95% CI -1.2 to 1.1). There was one immediate complication related to analgesics. Delayed complications were caused by retained products and infection. INTERPRETATION: With appropriate government training, mid-level health-care providers can provide first trimester manual vacuum aspiration abortions as safely as doctors can.

Comparative phase III clinical trial of two injectable contraceptive preparations, depot-medroxyprogesterone acetate and Cyclofem, in Vietnamese women.

A multicenter clinical trial was conducted in Viet Nam, comparing two injectable contraceptive preparations: the three-monthly injectable depot-medroxyprogesterone acetate (DMPA) and the once-a-month injectable Cyclofem. A total of 600 volunteers were randomized to the two treatment groups and followed for one year. No pregnancy occurred during the trial. Approximately one quarter of the women in each group discontinued early from the trial. In the DMPA group, this was mostly because of amenorrhea and vaginal bleeding irregularities. In the Cyclofem group, an equal number discontinued because of menstrual problems and personal reasons. These personal reasons are probably related to the inconvenience of having to return to the clinic for injection on a monthly basis. Thus, Vietnamese women experience less side effects with Cyclofem than with DMPA, and once Cyclofem is made more widely available and is more accessible, it may better meet their needs than does DMPA.