A randomised controlled trial of intravaginal dinoprostone, intravaginal misoprostol and transcervical balloon catheter for labour induction.

OBJECTIVE: To compare the efficacy and safety of induction of labour by vaginal application of dinoprostone or misoprostol or transcervical insertion of a balloon (Bard) catheter.

DESIGN: A non-blinded, randomised, controlled trial.

SETTING: A tertiary level Swedish hospital.

POPULATION: A total of 592 women who had undergone full-term pregnancies, not previously been subjected to a caesarean section, and required induction of labour for common, routine indications.

METHODS: Women were randomly assigned to induction of labour using intravaginal dinoprostone (2 mg once every 6 hours) or misoprostol (25 micrograms once every 4 hours) or a transcervical balloon catheter.

MAIN OUTCOME MEASURES: The time interval between induction to delivery in general and vaginal delivery in particular, the mode of delivery, maternal and neonatal parameters of outcome.

RESULTS: Of the 588 subjects included in the final intention-to-treat analysis, 191 were assigned to treatment with dinoprostone, 199 with misoprostol and 198 with the balloon catheter. The shortest mean induction-to-delivery interval was obtained with the catheter (12.9 hours versus 16.8 and 17.3 hours for dinoprostone and misoprostol, respectively). The efficacies of the two prostaglandins were similar. The maternal and neonatal outcomes associated with each of the three procedures were similar.

CONCLUSIONS: Induction of labour with a transcervical balloon catheter is effective and safe and can be recommended as the first choice. The two prostaglandins, dinoprostone and misoprostol, were shown to be equally effective and safe, while misoprostol costs significantly less and is easier to store.