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%.
The purpose of this pilot study is to determine if antepartum betamethasone given to mothers
undergoing elective cesarean section (ECS) delivery at term or near term gestation (>34 and
< 40 weeks of gestation) is safe and feasible in reducing neonatal respiratory morbidity and
the related admissions to neonatal intensive care units (NICU).
The data from this pilot study will be used to support a NIH application for a multicenter
randomized trial to determine, if compared to placebo treatment, antenatal betamethasone
initiated 2-7 days prior to an ECS results in decreased occurrence of respiratory morbidity
and NICU admissions in the newborn.
The multicenter protocol was recently reviewed by the NICHD network for clinical trial. The
reviewers were enthusiastic about the scientific merit and public health importance of the
study but asked for a pilot study to determine feasibility before launching the national
trial. Given the rise in the rate of CS deliveries, we project substantial health cost
savings from this preventive strategy if it were found to be successful in reducing neonatal
- Pregnant women >/= 34 weeks gestation scheduled to undergo operative delivery within
48-72 hours after study enrollment
- 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
Lucky Jain, M.D.
Emory University Department of Pediatrics, Division of Neonatology