Caesarean and Corticotherapy

• Register: ClinicalTrials.gov
• Last refreshed on: 26 October 2015
• Main ID: NCT00446953
• Date of registration: 12/03/2007
• Prospective Registration: No
• Primary sponsor: University Hospital, Strasbourg, France
• Public title: Caesarean and Corticotherapy
• Scientific 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.
• Date of first enrolment: February 2007
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00446953
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Bruno Langer, MD
• Affiliation: Les Hôpitaux Universitaires de Strasbourg

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Neonatal Distress

Intervention(s)

Other: placebo

Drug: betamethasone

Primary Outcome(s)

Neonatal respiratory distress [Time Frame: 15 days]

Secondary ID(s)

3740

Source(s) of Monetary Support

Please refer to primary and secondary sponsors