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A randomized controlled trial comparing labor induction with vaginal PGE2 tablets and foley catheter for cervical ripening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PGE2 | Active Comparator | Patients allocated to vaginal PGE2 (Prostin) for cervical ripening |
|
| Foley catheter | Active Comparator | Patients allocated to foley catheter placement for cervical ripening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostin (PGE2) tablets | Drug |
| ||
| Foley catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Time to active labor | Hours from foley cather placement or first PGE2 tablet placment to active labor, defined as cervical dilitation >4 cm and/or cervical effacement>80% | Post labor- up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Delivery within 24 hours | Delivery within 24 hours from foley catheter /first PGE2 tablet palcement | post-labor - up to 24 hours |
| Cesarean section rate | Delivery via cesarean section |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hadas Ganer Herman, MD | Contact | 972526206696 | hadassganer@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edith Wolfson Medical Center | Recruiting | Holon | Israel |
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| ID | Term |
|---|---|
| C501608 | KLK15 protein, human |
| D015232 | Dinoprostone |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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|
| post labor - up to 24 hours |
| Maternal complications | Documented complications during labor, including: excessive hemmorhage, infection (chorioamnionitis) | participants will be followed for labor course and the duration of hospital stay, an expected average of 5 days |
| Neonatal complications | Documented complications such as non-reassuring fetal heart rate, fetal pH, NICU admission, early neonatal sepsis | Neonates of participants will be followed for labor course and the duration of hospital stay, up to 1 month |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |