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OpenTrials
Completed

NCT Number: NCT00446953

Caesarean and Corticotherapy

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.

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Key information

Conditions

Neonatal Distress

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Le Parc Centre pour la Mère et l'Enfant, Colmar, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Betamethasone

Drug

2x12 mg betamethazone c-section at 38 weeks

Placebo

Other

c-section at 39 weeks

Primary outcomes

  1. Neonatal respiratory distress

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Mar 13, 2007
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.