ObjectivesThe aim of the study was to compare the efficacy and safety of two methods, a double balloon device and a vaginal prostaglandin E1 analog, for preinduction cervical ripening in term pregnancy. Study designThis prospective, randomized, controlled clinical trial was conducted at Ain-Shams Maternity Hospital during the period from January 2010 to January 2012. The included women were aged 18-40 years and were recruited from among women planned for elective induction of labor at term because of medical disorders or crossing of their due dates. The included women were randomized into two groups: group 1 (the study group) and group 2 (the control group). Group 1 included women who were subjected to cervical ripening using a cook double balloon device. The control group (group 2) included women who were subjected to cervical ripening using the prostaglandin E1 analog misoprostol. Randomization was done by the use of sealed, opaque envelopes at 1 : 3 ratio. The main outcome measures were induction to delivery interval, cesarean section rate, occurrence of complications, and oxytocin requirement. ResultsThere was no statistically significant difference between the two groups with regard to cesarean delivery rates (17.5% in group 1 vs. 27.5% in group 2; P = 0.292). Induction to delivery interval was significantly longer in group 1 than in group 2 (median 23.5 h, 95% confidence interval 16.8-25.5, versus median 19.3 h, 95% confidence interval 11.8-25, respectively). Intrapartum fetal distress was significantly higher among women of group 2 when compared with those of group 1 (9.2 vs. 0%; P = 0.047). There was a significantly higher rate of need for oxytocin infusion for augmentation of labor among women of group 1 when compared with those of group 2 (92.5 vs. 64.9%, respectively; P = 0.001). ConclusionBoth methods showed comparable results regarding safety and mode of delivery. While the double balloon catheter was associated with longer induction to delivery interval among primiparous women, it was associated with a lower rate of intrapartum fetal distress. However, there was no difference between the two groups regarding 5-min Apgar scores. Thus, because of its high cost, it is difficult to adopt the double balloon catheter for preinduction cervical ripening at our institution.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.