Caesarean and Corticotherapy

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Strasbourg, France Identifier:
First received: March 12, 2007
Last updated: October 13, 2015
Last verified: September 2013

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.

Condition Intervention Phase
Neonatal Distress
Drug: betamethasone
Other: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Neonatal respiratory distress [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: February 2007
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
2x 12 mg betamethazone
Drug: betamethasone
2x12 mg betamethazone c-section at 38 weeks
Placebo Comparator: 2
no drugs
Other: placebo
c-section at 39 weeks


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00446953

Le Parc Centre pour la Mère et l'Enfant
Colmar, France, 68000
Centre Hospitalier de Haguenau
Haguenau, France, 67504
Hôpital de Hasenrain
Mulhouse, France, 68051
Schiltigheim, France, 67303
Hôpital de Hautepierre
Strasbourg, France, 67000
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: Bruno Langer, MD Les Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France Identifier: NCT00446953     History of Changes
Other Study ID Numbers: 3740
Study First Received: March 12, 2007
Last Updated: October 13, 2015
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
Caesarean section
Neonatal distress

Additional relevant MeSH terms:
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on November 30, 2015