NCT03045939

Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours

Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours. A Randomized Multicenter Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Bnai Zion Medical Center · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the insertion of double balloon device (DBD) for cervical ripening for 12 h vs 6 hours.

Detailed description

This randomized controlled study is designed to: 1. To assess and compare the Bishop score when removing the DBD 12 hours' vs 6hours' after insertion. 2. To compare the efficacy (vaginal delivery rate and time to VD) in the two arm groups 200 women are expected to be randomized in to two arms. One will be randomized to DBD removal after 12 hours and the other to DBD removal after 6 hours. Each patient will sign an informed consent. The following screening will be completed: medical and gynecological history, general physical and gynecological examination, ultrasonography to exclude contraindication to vaginal delivery or insertion if the DBD and non stress test (NST) for baseline. Bishop score will be assessed. After confirming eligibility for study, randomization into the following groups will take place. Insertion of the DBD and removal 6 hours following its insertion. Insertion of the DBD and removal 12 hours following its insertion.

Conditions

• Induction of Labor
• Unfavorable Cervix

Interventions

Type	Name	Description
DEVICE	cervical ripening device	insertion of the double balloon device for 12 hours (standard care) vs 6 hours, following oxytocin IV infusion according local protocol guidelines as mentioned above

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-02-01
• Completion: 2019-03-01
• First posted: 2017-02-08
• Last updated: 2019-03-05

Locations

1 site across 1 country: Israel