• S Kehl, J Ziegler, E Schleussner, B Tuschy, S Berlit, J Kirscht, F Hägele, C Weiss, J Siemer, and M Sütterlin.
• Department of Obstetrics and Gynaecology, University Medical Centre Mannheim, Heidelberg University, Heidelberg, Germany; Department of Obstetrics and Gynaecology, Erlangen University Hospital, Erlangen, Germany.
• BJOG. 2015 Jan 1; 122 (1): 129-36.

ObjectiveTo evaluate the efficacy of inducing labour using a double-balloon catheter and oral misoprostol sequentially, in comparison with oral misoprostol alone.DesignA multicentre randomised controlled trial.SettingFive hospitals in Germany.PopulationA total of 326 pregnant women with an unfavourable cervix undergoing labour induction at term.MethodsWomen were randomly assigned according to a computer-generated allocation sequence to sequential use of double-balloon catheter and oral misoprostol (study group) or oral misoprostol alone (control group). In the study group, the double-balloon catheter was used the first day before starting oral misoprostol the second day.Main Outcome MeasuresThe primary outcome measure was the induction-to-delivery interval, and a further outcome parameter was delivery within 48 hours.ResultsThe median times for induction of labour until delivery were 32.4 hours in the study group and 22.5 hours in the control group (P = 0.004). This difference was not seen when evaluating according to parity (nulliparous, P = 0.19; parous, P = 0.06). The rate of vaginal delivery within 48 hours did not differ between both groups. The number of applications of misoprostol (two versus three, P < 0.001) and the dose of misoprostol used was lower in the study group (100 versus 200 μg, P < 0.001). In the study group, there were more Apgar scores of <7 at 5 minutes (8 versus 1, P = 0.04).ConclusionsThe use of a double-balloon catheter on the first day, before starting oral misoprostol on the second day, did not improve the induction to delivery interval and the rate of delivery within 48 hours, in comparison with oral misoprostol alone.© 2014 Royal College of Obstetricians and Gynaecologists.

30 keywords...

hide…