NCT00139256

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%.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

1.7 years

First QC Date

August 29, 2005

Last Update Submit

November 25, 2013

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

GlucocorticoidAntepartum Betamethasone TreatmentElective Cesarean SectionRespiratory Distress in Infants

Outcome Measures

Primary Outcomes (1)

  • The primary outcome to be studied is the need for NICU admission and/or oxygen therapy or PPV for >30 minutes.

    Respiratory distress in the first 24 hours after birth.

    24 hours

Study Arms (2)

Betamethasone

EXPERIMENTAL

Betamethasone injection

Drug: Betamethasone

Placebo

PLACEBO COMPARATOR

Placebo injection

Drug: Betamethasone

Interventions

BetamethasoneDRUG

Betamethasone injection

BetamethasonePlacebo

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University affiliated newborn intensive care units

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • 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.

    PMID: 34935127DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Interventions

Betamethasone

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Lucky Jain, M.D.

    Emory University Department of Pediatrics, Division of Neonatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

August 1, 2005

Primary Completion

April 1, 2007

Study Completion

September 1, 2007

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

US(1)