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This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 induction in premature rupture of membranes. Half of participants will be used combine transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will be used alone vaginal prostaglandin E2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PGE2 with Foley balloon catheter | Active Comparator | 10 mg PGE2 vaginal ovul will be inserted to the posterior fornix and an 18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix |
|
| PGE2 vaginal ovule | No Intervention | 10 mg PGE2 vaginal ovule will be inserted to the posterior fornix |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foley balloon catheter | Device | 18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix |
|
| Measure | Description | Time Frame |
|---|---|---|
| induction-to- delivery time | the length of time between the beginning of induction and the end of labor | an average of one year |
| Measure | Description | Time Frame |
|---|---|---|
| tachysystole | uterine contractions more than 3 in 10 minutes | an average of one year |
| chorioamnionitis | clinical chorioamnionitis(Maternal fever and Fetal tachycardia >160/min and Maternal tachycardia >100/min |
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Inclusion Criteria:
Exclusion Criteria:
pregnant women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ahmet eser | Contact | 905067136880 | hicoice@yahoo.com | |
| and yavuz | Contact | 905062224075 | andyavuz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| ahmet eser | Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doga | Recruiting | Istanbul | Kucukcekmece | 34303 | Turkey (Türkiye) |
| 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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| an average of one year |
| postpartum hemorrhage | abnormal uterine bleeding after birth | an average of one year |
| neonatal outcome | APGAR scores | an average of one year |
| admission to neonatal intensive care unit | admission to neonatal intensive care unit | an average of one year |
| Zeynep Kamil Education and Research Hospital | Recruiting | Istanbul | Uskudar | 34668 | Turkey (Türkiye) |
|