Foley catheter vs oral misoprostol for the induction of labor: an individual participant data meta-analysis.

Objectives To compare the effectiveness and safety of Foley catheter and oral misoprostol use in induction of labor (IOL). Methods We searched the Cochrane Review on Mechanical Methods for Induction of Labour, Ovid MEDLINE, Embase via Ovid, Ovid Emcare, CINAHL Plus, ClinicalTrials.gov and Scopus from inception to April 2019, for randomized controlled trials comparing Foley catheter to oral misoprostol for IOL in viable singleton gestations. Co-primary outcomes were vaginal birth, a composite of adverse perinatal outcome, and a composite of adverse maternal outcome. The quality of included RCTs was assessed using the Cochrane Risk of Bias 2 tool and the certainty of evidence was evaluated using the GRADE approach. We used two-stage random-effects model for the meta-analysis according to the intention-to-treat principle and assessed interactions between treatment and baseline characteristics. Results From seven eligible studies, four shared individual participant data for a total of 2815 participants, of which 1399 women were assigned to Foley catheter and 1416 to oral misoprostol. Compared with oral misoprostol, Foley catheter recipients had a slightly decreased chance of having a vaginal birth (4 trials, 2815 women, RR 0.95, 95% CI 0.91-0.99, I2 2.0%, moderate-certainty evidence). Foley catheter may lead to fewer adverse perinatal outcomes in comparison with oral misoprostol (4 trials, 2815 women, risk ratio [RR] 0.71, 95% CI 0.48-1.05, I2 14.9%, low-certainty evidence). Adverse maternal outcome did not differ (4 trials, 2815 women, RR 1.00, 95% CI 0.97-1.03, I2 0%, moderate-certainty evidence). Meta-analyses of effect-modifications did not show significant interactions between interventions, parity and gestational age on primary outcomes. Conclusions For women undergoing IOL Foley catheter is less effective than oral misoprostol as it was associated with fewer vaginal births. However, while we found no significant difference in maternal safety, Foley catheter induction may reduce adverse perinatal outcomes. This article is protected by copyright. All rights reserved.