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.

• Balloon
• extra-amniotic saline infusion
• labor induction

Acknowledgements

E.M. conceived of the study, led the design and plan for analysis, drafted the manuscript, and is the guarantor for the study. All co-authors (A.W., C.V., and M.H.) contributed to the design, analysis plan and editing of the manuscript. All authors approved the final version of the submitted manuscript.

Details of ethics approval

The study was approved by the Israeli Ministry of Health (reference number: HTA4174) and by the Hillel Yaffe local Institutional Review Board (reference number: 15/2007) 28 November 2007.

The trial is registered at ClinicalTrials.gov, number NCT00604487 by the name “Induction of Labor in Patients with Unfavorable Cervical Conditions”.

Notes

^†Presented at the 59th Annual Meeting of the Society for Gynecologic Investigation, San Diego, CA, March 21–24 2012.