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Induction of labor in women desiring TOLAC has long been a topic of controversy. The paucity of published data on mechanical cervical ripening in the setting of TOLAC and term PROM has led us to undertake the present clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expectant management | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double balloon cervical catheter | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| vaginal delivery rate | 20% higher vaginal delivery rate | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| safety | safety of the double balloon device in women with one previous cesarian section and PROM at >/=34 weeks by monitoring fetal heart rate, increased uterine hemorrhage, maternal hemodinamic changes, and uterine atony. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| satisfaction | maternal experience and satisfaction with the method of delivery that was applied | 48 hours |
Inclusion Criteria:
Exclusion Criteria: Patients having any of the following conditions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asnat Walfisch, MD | Contact | 050-4492200 |
| Name | Affiliation | Role |
|---|---|---|
| Asnat Walfisch, MD | Hillel Yaffe Medical Center | Principal Investigator |
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| 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 |
|---|---|
| D005322 | Fetal Membranes, Premature Rupture |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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