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

NCT ID: NCT00139256

Last Updated: 2013-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Respiratory Distress Syndrome, Newborn

Keywords

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Glucocorticoid Antepartum Betamethasone Treatment Elective Cesarean Section Respiratory Distress in Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Betamethasone

Betamethasone injection

Group Type EXPERIMENTAL

Betamethasone

Intervention Type DRUG

Betamethasone injection

Placebo

Placebo injection

Group Type PLACEBO_COMPARATOR

Betamethasone

Intervention Type DRUG

Betamethasone injection

Interventions

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Betamethasone

Betamethasone injection

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Lucky Jain

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lucky Jain, M.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University Department of Pediatrics, Division of Neonatology

Locations

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Emory University affiliated newborn intensive care units

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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Sotiriadis A, McGoldrick E, Makrydimas G, Papatheodorou S, Ioannidis JP, Stewart F, Parker R. Antenatal corticosteroids prior to planned caesarean at term for improving neonatal outcomes. Cochrane Database Syst Rev. 2021 Dec 22;12(12):CD006614. doi: 10.1002/14651858.CD006614.pub4.

Reference Type DERIVED
PMID: 34935127 (View on PubMed)

Other Identifiers

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0894-2003

Identifier Type: -

Identifier Source: org_study_id