Caesarean and Corticotherapy

Phase 4

Completed

• Conditions: Neonatal Distress
• Interventions: Other: placebo; Drug: betamethasone

• Registration Number: NCT00446953
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-03-12
• Study First Submitted QC: 2007-03-12
• Study First Posted: 2007-03-13
• Status Verified: 2013-09
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• woman who needs elective caesarean section

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Exclusion Criteria

• multiple pregnancy
• toxaemia
• rhesus immunization
• fetal infection
• maternal gastro-duodenal ulcer
• mother HIV+
• prior injection of corticosteroid during the pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	no drugs
1	betamethasone	2x 12 mg betamethazone

Primary Outcome Measures

Name	Time	Method
Neonatal respiratory distress	15 days

Trial Locations

Locations (5)

Cmco-Sihcus; 🇫🇷 Schiltigheim, France

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

Centre Hospitalier de Haguenau; 🇫🇷 Haguenau, France

Hôpital de Hasenrain; 🇫🇷 Mulhouse, France

Hôpital de Hautepierre; 🇫🇷 Strasbourg, France