Introduction
In light of recent evidence in the literature advocating for elective induction of uncomplicated singleton pregnancies at 39 weeks of gestation, [1] we can expect that induction of labour (IOL), which is one of the most common procedures a woman may experience in pregnancy, will become even more frequently employed. As such, there is a pressing need to study the most optimal method of cervical ripening among pharmacological, mechanical or surgical methods.
There are increasing amounts of evidence of safety and efficacy of mechanical IOL including an updated publication of the Cochrane Database of Systematic Reviews in 2012 [2] and a NICE interventional procedure guidance on the double balloon catheter (DBC).[3] A well-conducted meta-analysis by Du et al. published in 2016 demonstrated that mechanical IOL with cervical ripening balloons appeared to have similar efficacy profiles, and greater safety and cost-effectiveness than prostaglandin (PGE2) agents. A randomised-controlled study on 98 women in 2018 specifically addressing patient experience between IOL methods found that pain during induction was significantly lower with the double-balloon cervical ripening balloon while other satisfaction and acceptability scores were similar. [4]
To the best of our knowledge, current large randomised controlled trials have not directly examined the immediate effects or potential adverse events that occur in the first 12 hours of double-balloon catheter or first prostaglandin insertion in IOL. [5, 6,7,8,]Outcomes on the efficacy and safety during this period will be valuable to support its clinical application in high risk pregnancies. We conducted a multi-centre study to specifically evaluate the use of DBC in IOL in a Southeast-Asian population with regards to adverse effects in 12 hours after insertion while using a non-incremental balloon-filling regime.