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

Abstract

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.

Keywords: IOL; balloon catheter; cervical ripening; labor induction; meta-analysis; systematic review.