Caesarean and Corticotherapy

University Hospital, Strasbourg, France

Status and phase: Completed; Phase 4

Conditions: Neonatal Distress

Treatments: Drug: betamethasone; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00446953

3740

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Female

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

2x 12 mg betamethazone

Treatment:

Drug: betamethasone

2

Placebo Comparator group

Description:

no drugs

Treatment:

Other: placebo