Randomised controlled trial to compare safety and efficacy of vaginal versus oral route of misoprostol for induction of labour in term pregnancy with unfavourable cervix

摘要

Background: The objective of the study was to compare safety and efficacy of vaginal versus oral route of misoprostol for induction of labour in term pregnancy. Methods: A total of 100 pregnant women with clinical indication for labour induction and poor bishops score were randomly assigned to receive vaginal or oral misoprostol. Group A received 25 μg of misoprostol vaginally (maximum up to 3 doses 4 hourly interval) and group B received 25 μg of misoprostol orally (up to 5 doses 2 hourly interval) in solution form. Maternal and fetal outcomes were compared in both groups to assess the safety and efficacy of vaginal versus oral route. Results: Fifty women received vaginal and 50 women received oral misoprostol. Average interval from induction to active stage was shorter in oral misoprostol (7.42±4.2 hours versus 10.30±5.1 hours) (p=0.006). There was no significant difference (p=0.272) in the average interval from induction to delivery between the vaginal group (14.42±5.01hrs) and oral group (13.14±5.5 hrs). No significant difference in caesarean section rates (p=0.42). Incidence of hyperstimulation was significantly higher (p=0.025) in vaginal group as compared to oral group (18 % vs 4 %). Incidence of nausea, vomiting, vaginal or cervical tears and postpartum hemorrhage were comparable in both the groups. There were no statistically significant differences in neonatal outcomes. Conclusions: Oral misoprostol has a better safety profile than vaginal route as the incidence of hyperstimulation and tachysystole was significantly more in vaginal group, although there were no significant differences in the maternal and neonatal outcomes.