Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours. A Randomized Multicenter Controlled Trial
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:
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.
Inclusion Criteria:
Parous patients 18 years of age or older.
Diagnosed to be parous pregnant women with an indication for induction of labour.
Having a Bishop score of 5 or less.
Diagnosed as having a singleton pregnancy in a vertex presentation, with intact membranes, and no significant regular uterine contraction at gestational age of 37 completed gestational weeks or more.
Willingness to comply with the protocol for the duration of the study.
Have signed the informed consent.
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Exclusion Criteria:
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