Multicentre randomised controlled trial comparing the safety in the first 12 h, efficacy and maternal satisfaction of a double balloon catheter and prostaglandin pessary for induction of labour
Document Type
Article
Publication Date
1-1-2022
Abstract
Objective To evaluate the safety in the first 12 h, efficacy and maternal satisfaction of a double balloon catheter (DBC) with vaginal prostaglandin (PGE) for induction of labour (IOL). Methods 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 12 h after insertion. Women were assigned randomly to cervical ripening with either a DBC or a prostaglandin pessary. The adverse events in the 12 h after DBC or first prostaglandin inserted, the efficacy of a DBC to a prostaglandin in labour induction and maternal satisfaction were evaluated. Results 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 4 cm 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. Conclusion 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.
Keywords
Induction of labour, Double balloon catheter, Prostaglandin E, Safety, Efficacy, Satisfaction
Divisions
obstetrics
Funders
SingHealth DukeNUS OBGYN Academic Clinical Program (ACP) Grant
Publication Title
Archives of Gynecology and Obstetrics
Volume
305
Issue
1
Publisher
Springer Verlag (Germany)
Publisher Location
TIERGARTENSTRASSE 17, D-69121 HEIDELBERG, GERMANY