Caesarean and Corticotherapy
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.
1 other identifier
interventional
200
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2007
Longer than P75 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 12, 2007
CompletedFirst Posted
Study publicly available on registry
March 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedDecember 22, 2025
December 1, 2025
6.7 years
March 12, 2007
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neonatal respiratory distress
15 days
Study Arms (2)
1
EXPERIMENTAL2x 12 mg betamethazone
2
PLACEBO COMPARATORno drugs
Interventions
Eligibility Criteria
You may qualify if:
- woman who needs elective caesarean section
You may not qualify if:
- multiple pregnancy
- toxaemia
- rhesus immunization
- fetal infection
- maternal gastro-duodenal ulcer
- mother HIV+
- prior injection of corticosteroid during the pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Le Parc Centre pour la Mère et l'Enfant
Colmar, 68000, France
Centre Hospitalier de Haguenau
Haguenau, 67504, France
Hôpital de Hasenrain
Mulhouse, 68051, France
Cmco-Sihcus
Schiltigheim, 67303, France
Hôpital de Hautepierre
Strasbourg, 67000, France
Related Publications (1)
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.
PMID: 28342389RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno Langer, MD
Les Hôpitaux Universitaires de Strasbourg
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2007
First Posted
March 13, 2007
Study Start
February 1, 2007
Primary Completion
October 1, 2013
Study Completion
November 1, 2013
Last Updated
December 22, 2025
Record last verified: 2025-12