Induction of Labor Clinical Trial
Official title:
Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours. A Randomized Multicenter Controlled Trial
This study will evaluate the insertion of double balloon device (DBD) for cervical ripening for 12 h vs 6 hours.
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.
;
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