Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Respiratory Distress Syndrome, Newborn

In brief

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%.

Key facts

Study ID

NCT00139256

Run by

Emory University

People needed

67

Starts

2005-08-01

Expected to finish

2007-09-01

Last updated by the study team

2013-11-27

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pregnant women >/= 34 weeks gestation scheduled to undergo operative delivery within 48-72 hours after study enrollment

You may not qualify if…

• Known contraindication to the use of betamethasone in the mother
• Known lethal or non-lethal congenital anomaly diagnosed antenatally
• Spontaneous labor
• Premature rupture of membranes

Where it is running

• Emory University affiliated newborn intensive care units — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.