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The goal of this interventional study is to evaluate the effectiveness of membrane stripping in cervical ripening compared to double balloon catheter induction.
The study population consists of women undergoing labor induction.
The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double Balloon Catheter induction | Active Comparator | A Double balloon catheter will be inserted for 12 hours in this group of women |
|
| Membrane stripping | Active Comparator | This group of women will undergo membrane stripping twice (every 4-6 hours) over a period of 12 hours |
|
| PGE2 induction | Active Comparator | This group of women will undergo cervical ripening using a vaginal PGE2 pessary |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double Baloon Catheter | Device | A double Baloon Catheter will be inserted for 12 hours to one of the arms of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of successful cervical ripening at the end of 12 hours, duration of cervical ripening | What percentage of the women in this arm had a successful cervical ripening after 12 hours | from 12 hours after intervention until patient&s discharge or 150 hours, whichever came first, assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of vaginal delivery within 24 hours | What percentage of the women in this arm delivered within 24 hours | from 12 hours after intervention until patients discharge or 150 hours, whichever came first, assessed up to 100 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gal Cohen, MD | Contact | +972545915788 | galcwork@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Recruiting | Kfar Saba | Central District | 4428164 | Israel |
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| ID | Term |
|---|---|
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Membrane Stripping | Procedure | Stripping will be considered as 3-5 rotations of separating the amniotic sac from the cervix and will be perfomed twice (every 4-6 hours) |
|
| PGE2 | Drug | A PGE2 vaginal pessary (Cervidil) will be inserted for 12-24 hours |
|
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |