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Comparison of two randomized group :
The aim is to demonstrate that programming caesarean section at 38 weeks of pregnancy, after antenatal corticosteroid, allows to avoid caesarean section in emergency (because of a labour before 39 weeks), without increasing the neonatal respiratory distress rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 2x 12 mg betamethazone |
|
| 2 | Placebo Comparator | no drugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| betamethasone | Drug | 2x12 mg betamethazone c-section at 38 weeks |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal respiratory distress | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Langer, MD | Les Hôpitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Le Parc Centre pour la Mère et l'Enfant | Colmar | 68000 | France | |||
| Centre Hospitalier de Haguenau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28342389 | Result | Sananes N, Koch A, Escande B, Aissi G, Fritz G, Roth E, Weil M, Bakri A, Bolender C, Meyer N, Vayssiere C, Gaudineau A, Nisand I, Favre R, Kuhn P, Langer B. Pilot randomised controlled trial comparing the risk of neonatal respiratory distress in elective caesarean section at 38 weeks' gestation following a course of corticosteroids versus caesarean at 39 weeks. Eur J Obstet Gynecol Reprod Biol. 2017 May;212:54-59. doi: 10.1016/j.ejogrb.2017.03.020. Epub 2017 Mar 10. |
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| ID | Term |
|---|---|
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Other |
c-section at 39 weeks |
|
| Haguenau |
| 67504 |
| France |
| Hôpital de Hasenrain | Mulhouse | 68051 | France |
| Cmco-Sihcus | Schiltigheim | 67303 | France |
| Hôpital de Hautepierre | Strasbourg | 67000 | France |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |