BETADOSE : Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth: a randomized, multicenter, double blind placebo-controlled non inferiority trial

Phase 1

• Conditions: Very preterm birth; MedDRA version: 19.0Level: LLTClassification code 10053593Term: Premature baby 26 to 32 weeksSystem Organ Class: 100000004868; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2016-001486-90-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-27
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 3142

Inclusion Criteria

- Singleton pregnancy
- Patient who has already received the first injection of betamethasone and term pregnancy <32 weeks of gestation
- Age > or = 18 years
- Patient with health insurance coverage

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3142
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Chromosomal aberrations and major fetal malformations
- Cervical dilatation > ou = 4 cm
- Patient who has already received a first betamethasone course

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified