Effectiveness and safety of a new vaginal misoprostol product specifically labeled for cervical ripening and labor induction
Source: Acta Obstetricia et Gynecologica Scandinavica, Volume 85, Number 6, June 2006 , pp. 706-711(6)
Publisher: Informa Healthcare
Abstract:Objective . The purpose of this study was to evaluate the effectiveness and safety of misoprostol in two different formulations: vaginal tablets of 25µg and one-eighth of a 200-µg oral tablet, also administered intravaginally, for cervical ripening and labor induction of term pregnancies with an indication for that. Methods . A single-blind, randomized, controlled clinical trial was carried out in 120 pregnant women who randomly received one of the two formulations. The main dependent variables were mode of delivery, need for additional oxytocin, time between beginning of induction and delivery, perinatal results, complications, and maternal side effects. Student's t , Mann-Whitney, χ 2 , Fisher's Exact, Wilcoxon and Kolmogorov-Smirnoff tests, as well as survival analysis, were used in the data analysis. Results. There were no significant differences between the groups in terms of general characteristics, uterine contractility, and fetal well-being during labor, cesarean section rates, perinatal outcomes, or maternal adverse events. The mean time between the beginning of cervical ripening and delivery was 31.3h in the vaginal tablet group and 30.1h in the oral tablet group, a difference that was not statistically significant. Conclusion . The results showed that the 25-µg vaginal tablets of misoprostol were as effective and safe for cervical ripening and labor induction as the dose-equivalent fraction of 200-µg oral tablets.
Document Type: Research article
Affiliations: 1: Department of Obstetrics and Gynecology, School of Medical Sciences (FCM), University of Campinas (UNICAMP) 2: Department of Obstetrics and Gynecology, School of Medical SciencesState University of São Paulo (UNESP), Botucatu
Publication date: 2006-06-01