Misoprostol dose and route after mifepristone for early medical abortion: a randomised controlled noninferiority trial.

OBJECTIVE: To compare 400 and 800 microg sublingual or vaginal misoprostol 24 hours after 200 mg mifepristone for noninferiority regarding efficacy in achieving complete abortion for pregnancy termination up to 63 days of gestation. DESIGN: Placebo-controlled, randomised, noninferiority factorial trial, stratified by centre and length of gestation. Misoprostol 400 or 800 microg, administered either sublingually or vaginally, with follow up after 2 and 6 weeks. SETTING: Fifteen obstetrics/gynaecology departments in ten countries. POPULATION: Pregnant women (n = 3005) up to 63 days of gestation requesting medical abortion. METHODS: Two-sided 95% CI for differences in failure of complete abortion and continuing pregnancy, with a 3% noninferiority margin, were calculated. Proportions of women with adverse effects were recorded. OUTCOME MEASURES: Complete abortion without surgical intervention (main); continuing live pregnancies, induction-to-abortion interval, adverse effects, women's perceptions (secondary). RESULTS: Efficacy outcomes analysed for 2962 women (98.6%): 90.5% had complete abortion after 400 microg misoprostol, 94.2% after 800 microg. Noninferiority of 400 microg misoprostol was not demonstrated for failure of complete abortion (difference: 3.7%; 95% CI 1.8-5.6%). The 400-microg dose showed higher risk of incomplete abortion (P < 0.01) and continuing pregnancy (P < 0.01) than 800 microg. Vaginal and sublingual routes had similar risks of failure to achieve complete abortion (P = 0.47, difference in sublingual minus vaginal -0.7%, 95% CI -2.6-1.2%). A similar pattern was observed for continuing pregnancies (P = 0.21). Fewer women reported adverse effects with vaginal than sublingual administration and with the 400-microg dose than the 800-microg dose. Of the women, 94% were satisfied or highly satisfied with the regimens, 53% preferred the sublingual route and 47% preferred the vaginal route. CONCLUSIONS: A 400-microg dose of misoprostol should not replace the 800-microg dose when administered 24 hours after 200 mg mifepristone for inducing abortion in pregnancies up to 63 days. Sublingual and vaginal misoprostol have similar efficacy, but vaginal administration is associated with a lower frequency of adverse effects.

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.

Evaluation of the significance of dietary folate from wild vegetables in Vietnam.

Data on the overall dietary folate intakes among high-risk groups in poor countries is very limited. Vegetables are considered good sources but the evaluation of their contribution is hampered by the lack of data on folate concentrations in many traditional foods. Data on the analysis of folate concentrations in 16 wild vegetables used in the Mekong Delta and the Central Highlands in Vietnam and an evaluation of the relative importance of different foods in folate intakes of women is presented. Vegetable samples were collected in four study villages, blanched and frozen samples were transported to Sweden for analysis. Freeze-dried samples were analysed for total folate quantification using a commercial radio protein binding assay. Daily folate intakes among women were estimated from 7-day food frequency interviews with 213 women. The folate concentration in the vegetable samples ranged from 10 to 96 microg/100 g. The mean estimated daily folate intake among the 213 women in the study areas was 251 microg. Vegetables contributed approximately one-third of the daily folate intake, of which 72% and 42%, respectively, in the two regions was from wild vegetables. A majority of the women (87%) got some dietary folate from wild vegetables and nearly one-third had mean daily folate intakes of > 50 microg from such hidden food sources. The evaluation of dietary folate is complicated by data gaps in food composition tables, the unreliability of existing food data, variations between methods used for folate analysis and limited understanding of the bioavailability of food folate.

Significance of wild vegetables in micronutrient intakes of women in Vietnam: an analysis of food variety.

The association between food variety and nutrient intake/health status among rural women was tested in two agro-ecological settings in Vietnam. Special emphasis was placed on the significance of wild vegetables 'Rau Dai' in micronutrient supply and on the usefulness of food variety analysis in determining their current role. Data from 7-day food frequency interviews and a nutrition/health survey with 93 and 103 rural women in the Mekong Delta and the Central Highlands, respectively, were used in the analysis. Energy and nutrient intakes in the groups with the highest food variety score (FVS) (high = > or = 21) in the two regions were compared to those with the lowest food variety score (low = < or = 15). The high FVS groups in both regions also had a more diversified diet in terms of food categories. With the exception of low iron and riboflavin intakes in all groups, the high FVS groups had relatively adequate diets. A large variety of vegetables was used and only approximately half of the vegetable species were cultivated. In both regions the high FVS groups used a significantly greater variety of vegetables than the low FVS groups. Wild vegetables contributed significantly to the overall micronutrient intakes, mostly carotene, vitamin C and calcium intakes, but only the contribution to carotene intake was significantly higher in the high FVS group. Overall, we conclude that a food variety analysis is a useful tool in capturing the dietary role of wild vegetables.