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Caesarean and Corticotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00446953
First Posted: March 13, 2007
Last Update Posted: October 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
  Purpose

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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446953


Locations
France
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
Cmco-Sihcus
Schiltigheim, France, 67303
Hôpital de Hautepierre
Strasbourg, France, 67000
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Bruno Langer, MD Les Hôpitaux Universitaires de Strasbourg
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00446953     History of Changes
Other Study ID Numbers: 3740
First Submitted: March 12, 2007
First Posted: March 13, 2007
Last Update Posted: October 14, 2015
Last Verified: September 2013

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

Additional relevant MeSH terms:
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents