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

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

Detailed Description
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This randomized controlled study is designed to: To assess and compare the Bishop score when removing the DBD 12 hours' vs 6hours' after insertion. 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.

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

Conditions
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Induction of Labor, Unfavorable Cervix

Intervention / Treatment
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* Device: cervical ripening device


Participation Criteria
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Eligibility Criteria
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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. - Exclusion Criteria: A non -vertex presentation Placenta previa Ruptured membranes Documented labour Foetal distress necessitating immediate intervention Proven malignancy of the cervix Active inflammatory or purulent condition of the lower genital tract Twin pregnancy Any other contraindication for vaginal delivery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 12 hours<br>This arm is the standard management that includes insertion of the DBD into the cervical canal according to manufacture guidelines, removal after 12 hours followed by artificial rupture of membranes and oxytocin infusion according to departments protocol. (a total of 10 units of oxytocin is infused, initiated with 10 cc/h, increased by 10cc every 20-30 min until 3-5 contractions are present, total of not more than 120 cc\h) | Device: cervical ripening device<br>* 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<br>* Other names: atad double balloon device;|
| Active Comparator: 6 hours<br>Removal of the DBD after 6 hours, followed by artificial rupture of membranes and oxytocin infusion according to departments protocol. (a total of 10 units of oxytocin is infused, initiated with 10 cc/h, increased by 10cc every 20-30 min until 3-5 contractions are present, total of not more than 120 cc\h) | Device: cervical ripening device<br>* 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<br>* Other names: atad double balloon device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time from insertion of the DBD to delivery | the time from insertion of the DBD until delivery will be assessed for each patient from each arm by hours/minutes | minutes or hours from insertion to delivery, assessed up to an estimated total of 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of vaginal delivery | calculation of the rate of vaginal delivery in each arm will be calculated by number of Vaginal deliveries in each arm and the percentage. | 1 year | 
| maternal and neonatal adverse events |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical ripening, labor induction, double balloon device, cervical ripening device, unfavorable cervix