Dose Reduction of Antenatal Betamethasone Given to Prevent the Neonatal Complications Associated With Very Preterm Birth: a Randomized, Multicentre, Double Blind Placebo-controlled Non Inferiority Trial

P150944

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.

2017-01-01

2020-01-05

2020-01-05

Completed

Early phase I

3250

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

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2023-02-03