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A prospective randomized controlled trial to evaluate the safety and efficacy of labor induction with a double balloon catheter (Atad Ripener Device) in women desiring TOLAC (trial of labor after cesarean) with PROM (pre labor rupture of membranes).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double balloon catheter for induction of labor | Experimental | in this group a trans-cervical double balloon catheter will be inserted. Following device insertion, 20 minutes of external monitoring is performed. The patient will be transferred to the Ob/Gyn ward for hospitalization. 12 hours after insertion of the device the balloons are deflated and the device removed. At this stage the patient is assessed for a second Bishop score and expectant management is resuming. |
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| Expectant management | No Intervention | Women in the expectant management group will be transferred to the Ob/Gyn ward for hospitalization and conservative management until spontaneous labor ensues. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double Balloon catheter for induction of labor | Device | With the patient in lithotomy position or lying supine in bed, a speculum is inserted to visualise the cervix. The device is inserted into the cervix using long forceps until both balloons enter the cervical canal. Then, the uterine balloon is inflated with 20 ml of saline (by means of a 20 ml syringe). The device is then pulled out until stopped by the uterine balloon covering the internal cervical os. At this point the cervico-vaginal balloon located at the external os is inflated with 20 ml of saline and the speculum is removed. Then both balloons are additionally inflated with alternate increments of 20 ml normal saline to a total volume of 80 ml in each balloon. The device is loosely taped to the patient's inner thigh. |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal birth after cesarean (VBAC) rates | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| PROM to delivery interval (time) | 5 days | |
| intrapartum and post-partum infection rates | 5 days | |
| Cesarean section rates |
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Inclusion Criteria:
Only patients who meet the following criteria will be approached.
Exclusion Criteria:
Patients having any of the following conditions will be excluded from the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gil Gutvirtz, MD | Contact | 972509630022 | Giltzik@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka University Medical Center | Recruiting | Beersheba | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36996264 | Derived | de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4. |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005322 | Fetal Membranes, Premature Rupture |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007744 | Obstetric Labor Complications |
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| ID | Term |
|---|---|
| D007751 | Labor, Induced |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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200 pregnant women with one previous cesarean section and PROM along with an unfavourable cervix (Bishop Score ≤ 6) are expected to be entered into the study.
All eligible women will be presented with the study protocol by a study coordinator.The following screening medical procedures will be completed:
Medical and gynecological history, physical and vaginal speculum examination, Ultrasonography and a non-stress test (NST).
For eligible patients, and following an informed consent, group randomization will take place:
GROUP 1: Expectant management (standard protocol). GROUP 2: Insertion of a balloon cervical catheter (study group).
The randomization process will be as follows:
A. The eligible patient will sign the informed consent prior to randomization. B. The patient will receive a subject number for the study (from 1 to 200) The study coordinator will open a sealed envelope with the patient's study number to reveal the patient's assigned study group.
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| 5 days |