Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
Status:
Terminated
Trial end date:
2007-09-01
Target enrollment:
Participant gender:
Summary
This is a randomized, multicenter, double blind, placebo controlled trial of betamethasone
versus a placebo given prior to the mothers at term and near term gestation (>34 and <40
weeks of gestation) who are scheduled to undergo a planned Cesarean section. The study design
is to determine the efficacy and safety of betamethasone in the prevention of breathing
problems commonly seen in this population.
In infants born by elective Cesarean section, it is hypothesized that antenatal betamethasone
treatment will reduce the risk of neonatal intensive care unit (NICU) admission from 11% to
8% and/or oxygen therapy +/- positive pressure ventilation (PPV) for >30 minutes from 4.5% to
2.5%.