Repeat Antenatal Steroids Trial

• Status: Terminated
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

A course of steroids given to a mother who is in labor with a premature fetus will reduce the risk of the premature infant dying or having serious complications. This trial will test whether more than one course of antenatal steroids is more beneficial or risky to the infant than a single course.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The George Washington University Biostatistics Center
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate

Criteria

Inclusion criteria:

• Pregnant

• Gestational age > 23.0 wks and < 31.6 wks

• Singleton or twin pregnancy

• Intact membranes

• At-risk for spontaneous preterm delivery

• Received full course of corticosteroids within the previous 7 days

Exclusion criteria:

• Diagnosis of fetal lung maturity

• Chorioamnionitis

• Non-reassuring fetal testing

• Known major fetal anomaly

• Corticosteroid therapy, other than qualifying course

• Insulin dependent diabetes

• Active preterm labor at the time of randomization

• Delivery intended outside center

• Participation in any intervention study which influences neonatal morbidity or mortality

• Previous participation in this trial