NCT02469519

Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes

A Randomized Double-blinded Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome in the Patient With Prelabor Premature Rupture of the Membranes

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Pediatrix · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor premature rupture of the membranes.

Detailed description

This is a multicenter randomized double blinded trial that hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity including respiratory distress syndrome in pregnant women with a singleton gestation between 24w0d - 32w6d gestation who have documented premature rupture of the membranes.

Conditions

• Premature Birth

Interventions

Type	Name	Description
DRUG	Betamethasone - ACTIVE	antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.
OTHER	Normal Saline - PLACEBO	normal saline of the same quantity as with the experimental drug is to be given by injection 24 hours apart for two doses

Timeline

• Start date: 2016-03-03
• Primary completion: 2022-08-15
• Completion: 2022-10-31
• First posted: 2015-06-11
• Last updated: 2022-12-15

Locations

9 sites across 1 country: United States