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.

Amniotic fluid index measurements in normal pregnancy after 28 gestational weeks.

OBJECTIVE: The purpose of this study is to establish a normative scale of amniotic fluid index (AFI) or four-quadrant amniotic fluid index throughout gestation in uncomplicated singleton pregnancies, and to identify the lower and upper limits for each gestational week. METHOD: A prospective longitudinal study was used. One hundred seventeen uncomplicated singleton pregnancies were examined every 4 weeks between 28 and 42 week's gestation. The uterine cavity was divided into four quadrants. With the use of linear-array, real-time B-scanning, the vertical diameter of the largest pocket in each quadrant was measured. The amniotic fluid index is the sum of these four quadrants. RESULTS: The amniotic fluid index observations from regression equation curve were stratified in week-specific normative curves. The variation between mean AFI of the total population and the means of the preterm was significantly greater than term pregnancies (P<. 05). The AFI 2.5%, 5%, 10%, 90% 95% and 97.5% limits about the 50th (124 mm) were 68, 81, 90, 135, 144 and 145 mm, respectively, in term gestation. The 5th and 95th percentile serves as lower and upper limits of normal, respectively for 28-42 weeks gestation. CONCLUSIONS: Gestational age-specific values of AFI were established, determining the significant trends of changes in the amniotic fluid volume with gestation. The normogram may have a clinical benefit to accurate, reliable and semiquantitative diagnosis of oligohydramnios and polyhydramnios.