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Vaginal misoprostol tablets are used off-label to induce cervical ripening for induction of labor; however, controlled-release drug delivery would be preferable. In a manufacturer-sponsored phase II dose-ranging study, U.S. investigators randomized 374 pregnant women (≥36 weeks' gestation) who required labor induction to undergo cervical ripening with 100-µg, 150-µg, or 200-µg misoprostol vaginal inserts (MVIs). The primary outcome was proportion of vaginal births within 24 hours of misoprostol administration; continuous uterine and fetal heart rate monitoring were performed.
Women who received 200-µg MVI entered active labor fastest and had shortest median time to any delivery mode. In all, 24% of women in the 200-MVI group, compared with 3…