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No participants enrolled
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The aim of this study is to compare two different preparation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | sustained release preparation of prostaglandin E2 |
|
| B | Active Comparator | short-acting (instant-released) preparation of prostaglandin E2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostaglandin E2 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of vaginal deliveries within the 48 hours after cervical ripening | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of total vaginal deliveries | 48 hours | |
| Vaginal deliveries at 12 hours, 24 hours and 36 hours | 48 hours | |
| Number of hyperkinesia with or without fetal heart rate monitoring abnormalities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franck Perrotin, MD-PhD | Tours Universiity Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olympe de Gouges Women Health Centre, Bretonneau University Hospital | Tours | 37044 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11236117 | Background | Lyrenas S, Clason I, Ulmsten U. In vivo controlled release of PGE2 from a vaginal insert (0.8 mm, 10 mg) during induction of labour. BJOG. 2001 Feb;108(2):169-78. doi: 10.1111/j.1471-0528.2001.00039.x. | |
| 16553177 | Background | Strobelt N, Meregalli V, Ratti M, Mariani S, Zani G, Morana S. Randomized study on removable PGE2 vaginal insert versus PGE2 cervical gel for cervical priming and labor induction in low-Bishop-score pregnancy. Acta Obstet Gynecol Scand. 2006;85(3):302-5. doi: 10.1080/00016340500523685. |
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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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| 48 hours |
| Number of hypertonia with or without fetal heart rate monitoring abnormalities | 48 hours |
| Apgar score at 5 min less or equal 7 | 48 hours |
| Apgar score at 10 min less or equal 7 | 48 hours |
| Arterial pH less or equal 7.20 | 48 hours |
| Arterial base excess more than 12 | 48 hours |
| Number of maternal post-partum haemorrhage | 48 hours |
| Time to reach 3cm cervical dilatation | 48 hours |
| 17071427 | Background | El-Shawarby SA, Connell RJ. Induction of labour at term with vaginal prostaglandins preparations: a randomised controlled trial of Prostin vs Propess. J Obstet Gynaecol. 2006 Oct;26(7):627-30. doi: 10.1080/01443610600903362. |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |