Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2007-02-28
2013-11-30
Brief Summary
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* caesarean section planned at 38 weeks after 2 antenatal injections of 12 mg of betamethasone 48 h before.
* caesarean section planned at 39 weeks without corticosteroid.
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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
2x 12 mg betamethazone
betamethasone
2x12 mg betamethazone c-section at 38 weeks
2
no drugs
placebo
c-section at 39 weeks
Interventions
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betamethasone
2x12 mg betamethazone c-section at 38 weeks
placebo
c-section at 39 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* toxaemia
* rhesus immunization
* fetal infection
* maternal gastro-duodenal ulcer
* mother HIV+
* prior injection of corticosteroid during the pregnancy
FEMALE
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Bruno Langer, MD
Role: PRINCIPAL_INVESTIGATOR
Les Hôpitaux Universitaires de Strasbourg
Locations
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Le Parc Centre pour la Mère et l'Enfant
Colmar, , France
Centre Hospitalier de Haguenau
Haguenau, , France
Hôpital de Hasenrain
Mulhouse, , France
Cmco-Sihcus
Schiltigheim, , France
Hôpital de Hautepierre
Strasbourg, , France
Countries
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References
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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.
Other Identifiers
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3740
Identifier Type: -
Identifier Source: org_study_id