What is the comparative safety and effectiveness of balloon catheters versus vaginal prostaglandins for induction of labor?
Balloon catheters and vaginal prostaglandins as single agents are similarly effective for induction of labor with regard to a principal outcome of cesarean delivery rate. Individual participant meta-analysis allowed for analysis of composite outcomes of safety for mothers and infants. The use of balloon catheter was associated with reduced adverse outcomes for infants. For mothers, there was no difference in safety profile between the 2 methods. These results cannot be extrapolated to combination interventions including both vaginal prostaglandin and balloon catheter.
Plan de l'etude:
Meta-analysis (randomized controlled trials)
Several aggregate meta-analyses have demonstrated that balloon catheters and vaginal prostaglandins are equally effective for cervical ripening as part of labor induction. This collaborative group undertook an individual participant meta-analysis with a main purpose to establish a composite safety profile for both mothers and infants, something not easily accomplished with aggregate meta-analysis. They included individual patient data from 12 studies (N = 5460 participants) with authors who responded to the request for their data and provided data of adequate quality. Participants in all studies had a viable singleton term pregnancy. Studies could include single balloon catheter (n = 8), double balloon catheter (n = 3), or both (n = 1). The prostaglandin type was PGE2 (n = 8), PGE1 (n = 3), or both (n = 1). Interventions could not include concurrent balloon catheter and prostaglandin. Inclusion criteria required that the PGE1 dose was not more than 50 mcg every 4 or more hours, because of prior evidence that dosing exceeding that limit is not safe. The authors found that both approaches were similarly effective with regard to cesarean delivery rate, with effect size equivalent to aggregate meta-analyses. The composite maternal safety outcome measure included antibiotic use during labor, maternal fever, and severe postpartum hemorrhage, which was not statistically different between the 2 interventions. The composite infant safety outcome included an Apgar score of less than 7 at 5 minutes, arterial umbilical cord pH less than 7.1, and admission to the neonatal intensive care unit, which favored balloon catheters (adjusted odds ratio 0.84; 95% CI 0.71 - 0.99).
Linda Speer, MD
Professor and Chair, Department of Family Medicine
University of Toledo