Multicentre randomised controlled trial comparing the safety in the first 12h, efficacy and maternal satisfaction of a double balloon catheter and prostaglandin pessary for induction of labour.

Abstract

To evaluate the safety in the first 12h, efficacy and maternal satisfaction of a double balloon catheter (DBC) with vaginal prostaglandin (PGE) for induction of labour (IOL). We conducted a multicentre randomised controlled study of 420 patients from 1st January 2016 to 31st December 2017 to evaluate the use of DBC in IOL in an Asian population looking at the adverse effects in the first 12h after insertion. Women were assigned randomly to cervical ripening with either a DBC or a prostaglandin pessary. The adverse events in the 12h after DBC or first prostaglandin inserted, the efficacy of a DBC to a prostaglandin in labour induction and maternal satisfaction were evaluated. There were significantly less women with uterine hyperstimulation in the DBC (2 vs 24, p ≤ 0.0001) compared to the prostaglandin group. There were no women with uterine hyperstimulation and non-reassuring foetal status in the DBC while there were 5 women with uterine hyperstimulation and foetal distress in the prostaglandin group. Use of entonox was significantly less in the DBC group (p = 0.009). There were no significant differences in both groups in caesarean section, vaginal deliveries and time to delivery, although significant less time was needed to achieve cervical os dilation more than 4cm in the DBC group (p ≤ 0.0001). Neonatal birth outcomes were similar. Women's pain scores were similar for both methods. 80.1% of women allocated the DBC and 76.8% of women allocated the PGE were keen to recommend their method of induction. Double balloon catheter remains a good alternative method for inducing women in view of a good safety profile with low risk of hyperstimulation and high maternal satisfaction. ClinicalTrials.gov Identifier: NCT02620215.