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.