Caesarean and Corticotherapy
NCT00446953 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-12-22
Summary
Comparison of two randomized group :
* 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.
Conditions
- Neonatal Distress
Interventions
- DRUG
-
betamethasone
2x12 mg betamethazone c-section at 38 weeks
- OTHER
-
placebo
c-section at 39 weeks
Sponsors & Collaborators
-
University Hospital, Strasbourg, France
lead OTHER
Principal Investigators
-
Bruno Langer, MD · Les Hôpitaux Universitaires de Strasbourg
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-02-28
- Primary Completion
- 2013-10-31
- Completion
- 2013-11-30
Countries
- France
Study Locations
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