Comparison of two mechanical devices for cervical ripening: a prospective quasi-randomized trial

TLDR

The study aims to compare the efficacy of a Foley catheter with extra‑amniotic saline infusion versus a Cook cervical ripening balloon for cervical ripening. Women at term with singleton pregnancies were quasi‑randomly assigned to receive either a Foley catheter or a Cook balloon, and outcomes measured included time to delivery, vaginal delivery rates, and adverse events. The Foley catheter group had significantly shorter times to device expulsion and delivery compared with the Cook balloon, with no other outcome differences, indicating that the Foley catheter is superior because of its faster induction and lower cost.

Abstract

Objective: To compare the efficacy of two mechanical devices for cervical ripening: Foley catheter with extra-amniotic saline infusion and the Cook cervical ripening balloon. Methods: Women at term with a singleton pregnancy who presented for labor induction were randomly assigned to the Foley catheter or the Cook cervical ripening balloon (costs $3 and $41, respectively). The main outcome measures included time from device insertion to delivery, rates of successful vaginal delivery and occurrence of adverse events. Results: The study was completed by 188 women. Time from balloon insertion to expulsion and from insertion to delivery was significantly shorter in the Foley catheter group when compared with the Cook cervical ripening balloon group (6.9 ± 4.2 vs. 10.1 ± 4.7 hours, p = .001 and 19.6 ± 11.4 vs. 23.4 ± 15.5 hours, p = .03, respectively). There were no significant differences in other outcomes. Conclusions: Considering its shorter induction process and lower cost, Foley catheter with extra-amniotic saline infusion is superior to the Cook cervical ripening balloon for initiating cervical ripening.