Safety and efficacy of the double balloon catheter and the prostaglandin pessary: A multicentre randomised controlled trial

Abstract

Objective We compare the adverse events in the 12 hours after double balloon catheter(DBC) or first prostaglandin(PGE) inserted and the efficacy of DBC to that of PGE in labour induction. Design Multi-centre Randomised controlled Trial (RCT), in 2 centers with 2 arms: (i)DBC (ii)prostaglandin pessary. Setting 2 tertiary hospitals, Singapore and Malaysia Population Southeast-Asian women Method This is a prospective cohort randomised controlled study. 210 women were recruited in each center and assigned randomly to cervical ripening with either DBC or prostaglandin pessary. Main outcome The adverse events in the 12 hours after DBC or first PGE inserted and the efficacy of a DBC to that of a prostaglandin in labour induction were evaluated. Results There were significantly less women with uterine hyperstimulation in the double balloon catheter group (2 vs 24, p=<0.0001) compared to the prostaglandin group. There were no women with uterine hyperstimulation and non-reassuring fetal status in the double balloon group while there were 5 women with uterine hyperstimulation and fetal distress in the prostaglandin group. Use of pain relief was significantly less in the double balloon catheter group (p=0.009). There were no significant differences in both groups in mode and time to delivery, although significant less time was needed to achieve os dilation more than 4cm in the double balloon catheter group (p=<0.0001). Conclusion DBC remains a good alternative method for inducing women in view of low adverse events and a good safety profile with low risk of hyperstimulation. Keywords: Double balloon catheter;prostaglandin;hyperstimulation;induction of labour ClinicalTrials.govIdentifier:NCT02620215.URL:https://clinicaltrials.gov/ct2/show/NCT02620215