Safety and efficacy of double-balloon catheter for cervical ripening: a Bayesian network meta-analysis of randomized controlled trials

Abstract

Background: Various methods are used for cervical ripening during the induction of labor. Mechanical and pharmacological methods are commonly used for cervical ripening. A double-balloon catheter was specifically developed to ripen the cervix and induce labor; however, the efficacy of the double-balloon catheter in cervical ripening compared to other methods is unknown.

Methods: We searched five databases and performed a Bayesian network meta-analysis. Six interventions (double-balloon catheter, Foley catheter, oral misoprostol, vaginal misoprostol, dinoprostone, and double-balloon catheter combined with oral misoprostol) were included in the search. The primary outcomes were cesarean delivery rate and time from intervention-to-birth. The secondary outcomes were as follows: Bishop score increment; achieving a vaginal delivery within 24 h; uterine hyperstimulation with fetal heart rate changes; need for oxytocin augmentation; instrumental delivery; meconium staining; chorioamnionitis; postpartum hemorrhage; low Apgar score; neonatal intensive care unit admission; and arterial pH.

Results: Forty-eight randomized controlled trials involving 11,482 pregnant women were identified. The cesarean delivery rates of the cervical ripening with a double-balloon catheter and oral misoprostol, oral misoprostol, and vaginal misoprostol were significantly lower than cervical ripening with a Foley catheter (OR = 0.48, 95% CI: 0.23-0.96; OR = 0.74, 95% CI: 0.58-0.93; and OR = 0.79, 95% CI: 0.64-0.97, respectively; all P < 0.05). The time from intervention-to-birth of vaginal misoprostol was significantly shorter than the other five cervical ripening methods. Vaginal misoprostol and oral misoprostol increased the risk of uterine hyperstimulation with fetal heart rate changes compared to a Foley catheter. A double-balloon catheter with or without oral misoprostol had similar outcomes, including uterine hyperstimulation with fetal heart rate changes compared to a Foley catheter.

Conclusion: Double-balloon catheter did not show superiority when compared with other single method in primary and secondary outcomes of labor induction. The combination of double-balloon catheter with oral misoprostol was significantly reduced the rate of cesarean section compared to Foley catheter without increased risk of uterine hyperstimulation with fetal heart rate changes, which was shown in oral or vaginal misoprostol.

Keywords: Cervical ripening; Dinoprostone; Double-balloon catheter; Foley; Labor induction; Meta-analysis; Misoprostol.

Fig. 1

Flow chart of study selection

Fig. 2

Forest plots of network meta-analysis of all trials for primary and secondary outcomes

Fig. 3

Heat maps of cervical ripening interventions for 14 Outcomes. Each column represents a cervical ripening intervention, and each row represents an outcome. Each box is colored according to the SUCRA value of the corresponding intervention and outcome. The color scale consists of values that represent SUCRA which range from 0 (white, indicating a treatment is always last) to 1 (purple, indicating a treatment is always first). Uncolored boxes labeled “NA” show that the underlying treatment was not included for that particular outcome. The values in each box represent the SUCRA value of the corresponding treatment and outcome. NA, not applicable; SUCRA: surface under the cumulative ranking curve