Making cervical ripening EASI: a prospective controlled comparison of single versus double balloon catheters

Abstract

Objective: To compare the efficacy of two mechanical devices for cervical ripening: double versus single balloon catheters, both with extra-amniotic saline infusion (EASI).

Methods: Women at term with a singleton pregnancy presenting for labor induction were assigned to receive the double balloon catheter (with EASI) or the single balloon catheter (with EASI). Outcomes included time from device insertion to delivery, rates of successful vaginal delivery and occurrence of adverse events.

Results: One hundred and eighty-six women completed the study. Ripening success was comparable between the double and single balloon arms (96.4% versus 92.7%, p = 0.55, respectively). Balloon insertion to delivery interval was significantly shorter, and cesarean section rate was significantly lower in the double balloon arm compared with the single balloon arm (14.3 versus 15.8 h, p = 0.04 and 8.3% versus 20%, p = 0.05, respectively). There were no significant differences in maternal characteristics, satisfaction or adverse outcomes.

Conclusions: This study is the first documented assessment of the double balloon catheter combined with EASI. Our findings suggest that the double balloon catheter results in reduced time to delivery and higher vaginal delivery rates, compared with the single balloon catheter with EASI, without compromising maternal or fetal safety.

Trial registration: ClinicalTrials.gov NCT00604487.

Keywords: Balloon; extra-amniotic saline infusion; labor induction.