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Your journey
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More info
You can access this
clinical trial
if you have
Neonatal Complications
and you are
between 18 and 60
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

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.

Provided treatments

  • Drug: betamethasone 24 mg
  • Drug: 12mg betamethasone +placebo

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02897076. The sponsor of the trial is Assistance Publique - Hôpitaux de Paris and it is looking for 3250 volunteers for the current phase.
Official trial title:
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