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...
Date First Received: March 12, 2007
Last Updated: January 23, 2008
Verified by: University Hospital, Strasbourg, France, January 2008
Clinical Trial Phase: Phase 4 | Start Date: March 2007
Overall Status: Recruiting
Estimated Enrollment: 600
Brief Summary
Official Title: “Interest in Programming Caesarean Section at 38 Weeks of Pregnancy With Antenatal Betamethasone to Prevent Neonatal Respiratory Distress and to Avoid Emergency Caesarean Section Before Planned Date.”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Study Primary Completion Date: March 2009
Intervention(s) in this Clinical Trial
- Drug: betamethasone
- 2x12 mg betamethazone c-section at 38 weeks
- Other: placebo
- c-section at 39 weeks
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- 2x 12 mg betamethazone
- Placebo Comparator: 2
- no drugs
Outcome Measures for this Clinical Trial
Primary Measures
- Neonatal respiratory distress
- Time Frame: 15 days
Safety Issue?: Yes
- Time Frame: 15 days
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- woman who needs elective caesarean section
Exclusion Criteria:
- multiple pregnancy
- toxaemia
- rhesus immunization
- fetal infection
- maternal gastro-duodenal ulcer
- mother HIV+
- prior injection of corticosteroid during the pregnancy
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University Hospital, Strasbourg, France
Overall Clinical Trial Officials and Contacts
Bruno Langer, MD Principal Investigator Les Hôpitaux Universitaires de Strasbourg
Overall Contact: Bruno Langer, MD 0333 88127503 bruno.langer@chru-strasbourg.fr
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00446953
Study ID Number: 3740
ClinicalTrials.gov Identifier: NCT00446953
Health Authority: France: Ministry of Health
Clinical Trials Authorship and Review
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