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