Trans-cervical double balloon catheter with and without extra-amniotic saline infusion for cervical ripening: a prospective quasi-randomized trial

Abstract

Objective: To compare the efficacy and safety of the trans-cervical double balloon catheter with and without extra-amniotic saline infusion (EASI) for cervical ripening.

Methods: This is a secondary analysis of a prospective randomized study conducted between November 2007 and January 2011 evaluating different ripening methods. Women presenting for labor induction were assigned to receive the double balloon catheter with (study group) or without EASI (control group). Outcomes included time from device insertion to delivery, cesarean section rates, and adverse events.

Results: One hundred and sixty women completed the study. Cesarean section rate (8.3% in study group, versus 20% in controls p = 0.07) and ripening success were comparable between the groups. Catheter insertion to delivery interval was significantly shorter and spontaneous catheter expulsion rate was significantly higher in the study group (14:19 hours versus 20:45 hours, p < 0.001, and 68.5% versus 51%, p = 0.04, respectively). Hospitalization length was significantly shorter in the study arm. There were no differences in other outcomes evaluated. A multivariable analysis found the EASI to be an independent predictor of a shorter insertion to delivery interval.

Conclusions: The addition of EASI to the double balloon catheter for cervical ripening results in a shorter labor induction process without compromising its safety.

• Atad catheter
• cesarean section rate
• induction to delivery interval
• labor induction
• mechanical ripening

Declaration of interest

All authors declare that no authors (nor their institutions) received payments for their efforts on this project. The authors report no conflict of interests.

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) date: 28/11/2007.

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

Contribution to authorship

EM and AW conceived the study, led the design and plan for analysis, drafted the manuscript and are the guarantors for the study. All co-authors contributed to the design, analysis plan and editing of the manuscript. All authors approved the final version of the submitted manuscript.