At a glance
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Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
In Brief
A Phase 3 clinical trial evaluating Betamethasone and Placebo for Pregnancy and 3 related conditions. Completed, enrolled 2,831 participants across 17 sites.
Detailed Summary
This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period
Study Details
Timeline
Interventions
The active study drug, betamethasone. 3 mg per ml betamethasone sodium phosphate 3 mg per milliliter betamethasone acetate The first dose of study drug medication will be administered at randomization as 2 ml injection; the next dose of 2 ml will be administered 24 hours later.
Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.