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Trial record 66 of 272 for:    Betamethasone

Caesarean and Corticotherapy

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. Identifier: NCT00446953
Recruitment Status : Completed
First Posted : March 13, 2007
Last Update Posted : October 14, 2015
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.

Condition or disease Intervention/treatment Phase
Neonatal Distress Drug: betamethasone Other: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
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.
Study Start Date : February 2007
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Neonatal respiratory distress [ Time Frame: 15 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

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 identifier (NCT number): NCT00446953

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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
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Principal Investigator: Bruno Langer, MD Les Hôpitaux Universitaires de Strasbourg

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Responsible Party: University Hospital, Strasbourg, France Identifier: NCT00446953     History of Changes
Other Study ID Numbers: 3740
First Posted: March 13, 2007    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: September 2013
Keywords provided by University Hospital, Strasbourg, France:
Caesarean section
Neonatal distress
Additional relevant MeSH terms:
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Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents