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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 hours | Other | 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) |
|
| 6 hours | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cervical ripening device | 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 |
| 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 |
| 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 |
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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.
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inna Bleicher, Dr | Contact | +972506268345 | innakreinin@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bnai Zion Mc | Recruiting | Haifa | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39445570 | Derived | Sammour R, Dikopoltsev E, Sagi S, Vitner D, Bleicher I. Cervical ripening with a double balloon device for 6 h in patients with a long cervix: Secondary analysis of a randomized controlled trial. Int J Gynaecol Obstet. 2025 Mar;168(3):1055-1059. doi: 10.1002/ijgo.15955. Epub 2024 Oct 24. | |
| 32282603 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 10, 2019 | |
| Reset | Jul 31, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 10, 2019 | Jul 31, 2019 |
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|
| 1 year |
| Bleicher I, Dikopoltsev E, Kadour-Ferro E, Sammour R, Gonen R, Sagi S, Eshel A, Nussam L, Vitner D. Double-Balloon Device for 6 Compared With 12 Hours for Cervical Ripening: A Randomized Controlled Trial. Obstet Gynecol. 2020 May;135(5):1153-1160. doi: 10.1097/AOG.0000000000003804. |