Malitha PATABENDIGE

and 13 more

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Criteria: Randomised controlled trials (RCTs), viable singleton gestation, no language restrictions, published and unpublished data.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.