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

Phase 2

Terminated

• Conditions: Respiratory Distress Syndrome, Newborn
• Interventions: Drug: Betamethasone

• Registration Number: NCT00139256
• Lead Sponsor: Emory University

Brief 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%.

Detailed Description

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 morbidity.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-08-31
• Primary Completion: 2007-04
• Study Completion: 2007-09
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 67

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Betamethasone	Betamethasone	Betamethasone injection
Placebo	Betamethasone	Placebo injection

Primary Outcome Measures

Name	Time	Method
The primary outcome to be studied is the need for NICU admission and/or oxygen therapy or PPV for >30 minutes.	24 hours	Respiratory distress in the first 24 hours after birth.

Trial Locations

Locations (1)

Emory University affiliated newborn intensive care units; 🇺🇸 Atlanta, Georgia, United States