Six vs 12-hour balloon catheter placement for the induction of labor: a systematic review and meta-analysis of randomized controlled trials

Objective: Balloon catheters have shown promising results in the induction of labor (IOL); however, evidence regarding the optimal time of balloon catheter placement is still lacking. Thus, this study aims to evaluate the efficacy and safety of 6-hour placement compared to 12 hours.

Data source: We conducted a comprehensive search through a search strategy across "Embase, SCOPUS, PubMed (via MEDLINE), and Cochrane Central Register of Controlled Trials (CENTRAL)" from inception until April 20, 2024.

Study eligibility criteria: We included the randomized controlled trials (RCTs) evaluating the efficacy and safety of 6-hour balloon catheter placement compared with 12 hours for cervical ripening in IOL. Covidence was used to screen eligible articles.

Methods: All relevant outcome data were synthesized using risk ratios (RR) or mean differences (MD) with 95% confidence intervals (CIs) in meta-analysis models within RevMan 5.4.

Prospero id: CRD42024540935.

Results: We included five RCTs with 960 women undergoing the IOL with balloon catheter placement. Six-hour placement was associated with significant lower insertion to overall delivery interval (MD: -4.25, 95% CI [-5.34, -3.15], P<.00001) and insertion to vaginal delivery interval (MD: -4.65, 95% CI [-6.08, -3.23], P<0.00001) without significant difference in BISHOP score change (MD: -0.02, 95% CI [-0.23, 0.20], P=.88), catheter removal to delivery interval (MD: 0.72, 95% CI [-0.39, 1.83], P=.20) and total duration of oxytocin infusion (MD: -0.36, 95% CI [-0.85, 0.14], P=.16) compared to 12 hours. Also, significantly lower overall cesarean delivery (CD) rate (RR: 0.81, 95% CI [0.68, 0.96], P=.01) and CD due to malpresentation (RR: 0.39, 95% CI [0.16, 0.93], P=.03) were observed with 6-hour placement.

Conclusion: A planned 6-hour balloon catheter placement reduced insertion to delivery intervals and CD rate and has equal efficacy in BISHOP score change and catheter removal to delivery interval compared to 12 hours.