Caesarean and Corticotherapy

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Completed

CT.gov ID

NCT00446953

Collaborator

(none)

200

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Feb 1, 2007

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Neonatal respiratory distress [15 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Le Parc Centre pour la Mère et l'Enfant	Colmar	France	68000
2	Centre Hospitalier de Haguenau	Haguenau	France	67504
3	Hôpital de Hasenrain	Mulhouse	France	68051
4	Cmco-Sihcus	Schiltigheim	France	67303
5	Hôpital de Hautepierre	Strasbourg	France	67000