Dose Reduction of Antenatal Betamethasone Given to Prevent the Neonatal Complications Associated With Very Preterm Birth

• Status: Completed
• Trial end date: 2020-01-05
• Target enrollment: 0
• Participant gender: Female

Summary

Extensive animal studies have indicated that antenatal betamethasone exposure results in altered developmental trajectories of several fetal systems. Follow up of a randomized controlled trial has shown that antenatal betamethasone exposure might result in insulin resistance 30 years later. Furthermore, animal studies and randomized trials in Humans have clearly demonstrated that betamethasone-induced growth alterations were dose-related.

In ewes, a 50% reduced dose regimen resulted in maximal improvement in preterm lamb lung function, similar to those obtained after a full dose.

Our hypothesis is that antenatal betamethasone after a 50% dose reduction, justified by the potential long term effects of this drug, is not inferior to a full dose to promote fetal lung maturation in Humans.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate

Criteria

Inclusion Criteria:

• Singleton pregnancy

• Patient Having receipt the first injection of betamethasone and pregnancy term < 32 weeks of gestation

• Age > 18 years

• Patient affiliated to a social security regime

Exclusion Criteria:

• Chromosomal aberrations and major fetal malformations

• Cervical dilatation ≥ 4 cm and of cervical length ≥20mm.

• Patient who have already received a first course of betamethasone

• first intravenous injection of betamethasone