Single versus double-balloon catheters for the induction of labor of singleton pregnancies: a meta-analysis of randomized and quasi-randomized controlled trials
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To compare the efficacy of single- versus double-balloon catheter (SBC vs. DBC) for cervical ripening and labor induction with an unfavorable cervix.
Systematic review and meta-analysis of randomized controlled trials (RCTs) or quasi-RCTs (qRCT) regarding the use of SBC or DBC for labor induction of live singleton cephalic pregnancies (≥ 35 weeks) of any parity with an unripe cervix (Bishop score ≤ 6). Nine research databases were searched for original articles published in all languages up to November 2017 comparing both devices for labor induction. Five RCTs and one qRCT were included. Primary outcome measures were time from intervention (device placement) to birth time, vaginal delivery and cesarean section rates, and maternal satisfaction with the procedure. Risk of bias was evaluated with the Cochrane tool. Random effects models were used to combine data for meta-analyses. Summary measures were reported as mean differences and risk ratios (RR) with 95% confidence intervals.
Regardless of parity, pooled analyses of the six trials (n = 1060 women) found that mean intervention to birth time, vaginal delivery and cesarean section rates, and maternal satisfaction to the procedure were similar for both studied groups (SBC vs. DBC).
Measured primary outcome measures were similar regardless of the type of device used for labor induction of singleton pregnancies.
KeywordsCervical ripening Cervical priming Double-balloon catheter Single-balloon catheter Single-balloon Foley catheter Double-balloon Cook catheter Induction of labor
HL carried out the search strategy, extracted data and assessed the risk of bias. SJMD carried out the search strategy, extracted data and performed the meta-analyses. GRPR conceived the study, searched clinical trial registries and interpreted the results. PC searched clinical trial registries and interpreted the results. FRPL designed, conceived, supervised and interpreted the study, and drafted the article. All authors approved the final manuscript.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
This systematic review and meta-analysis was performed following the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) statement for meta-analyses. Formal institutional review board approval was not required due to the fact that this analysis consisted of the pooling of published studies.
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