Caesarean and Corticotherapy

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00446953

Enrollment

200

Registered

2007-03-13

Start date

2007-02-28

Completion date

2013-11-30

Last updated

2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Distress

Keywords

Caesarean section, Corticosteroids, Betamethasone, Neonatal distress

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.

Interventions

DRUGbetamethasone

2x12 mg betamethazone c-section at 38 weeks

OTHERplacebo

c-section at 39 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame
Neonatal respiratory distress	15 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026