Balloon catheter plus concurrent vaginal misoprostol versus vaginal
misoprostol alone for cervical ripening in induction of labour: An
individual participant data meta-analysis of randomised controlled
trials.
Abstract
Background: Cervical ripening in labour induction using a
combination of methods is gaining popularity, but the effectiveness and
safety of this approach are not clear. Objective: To compare
the effectiveness, perinatal and maternal safety of cervical ripening in
the induction of labour (IOL) using a balloon catheter with concurrent
low-dose vaginal misoprostol (combined group) versus low-dose vaginal
misoprostol alone. Search Strategy: MEDLINE, Embase, Emcare,
Scopus, Cochrane Library, WHO ICTRP and clinicaltrials.gov.
Selection Criteria: Randomised controlled trials (RCTs), viable
singleton gestation, no language restrictions, published and unpublished
data. Data Collection and Analysis: Systematic search,
screening for trustworthiness and study quality, and an individual
participant data (IPD) meta-analysis were conducted. Main
Results: Eight of 22 RCTs provided IPD, of which three were excluded
due to trustworthiness concerns after IPD checking (604 women). Thirteen
of 22 RCTs (59.1%) were identified as ‘ not meeting
trustworthiness criteria’. This IPD meta-analysis included five RCTs
(649 women): two had prospective, another two had retrospective trial
registrations, and one RCT was unregistered. Vaginal delivery rate,
composite adverse perinatal and maternal outcomes were comparable
between the two groups in the IPD meta-analysis. Vaginal delivery rate,
based on aggregate data from eight RCTs ‘meeting trustworthiness
criteria’ (IPD and non-IPD), had an Odds Ratio (OR) of 1.07 (95% CI
0.68;1.68). In comparison, data from thirteen RCTs ‘not meeting
trustworthiness criteria’ (IPD and non-IPD) showed an OR of 1.25 (95%
CI 0.88;1.77). Conclusions: Based on trustworthy data, the
effectiveness of the combined group and the low-dose vaginal misoprostol
group is likely to be comparable. We are uncertain about the safety of
using a balloon catheter with concurrent low-dose vaginal misoprostol
due to low data retrieval and trustworthiness concerns among the
underlying RCTs.