Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-09-30

Brief Summary

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The hypothesis of the study is that administration of antenatal steroid to women at high risk of preterm birth after 34 weeks of gestation would reduce the risk of respiratory complications, specifically Respiratory Distress Syndrome (RDS) or Transient Tachypnea of the Newborn (TTN) in late preterm babies.

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Detailed Description

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Conditions

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Respiratory Distress Syndrome, Newborn Transient Tachypnea of the Newborn

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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Antenatal steroids

Group Type EXPERIMENTAL

Betamethasone

Intervention Type DRUG

A single course of betamethasone (two doses of 12 mg/dose given at 24 hourly intervals)

Normal saline

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

Two doses of 2ml of normal saline given at 24 hourly intervals

Interventions

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Betamethasone

A single course of betamethasone (two doses of 12 mg/dose given at 24 hourly intervals)

Intervention Type DRUG

Normal Saline

Two doses of 2ml of normal saline given at 24 hourly intervals

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women between 34 0/7- 36 6/7 weeks of gestation
* High risk of preterm birth

Exclusion Criteria

* Multiple births
* Fetal congenital malformations
* A course of steroids within 2 weeks of randomization
* Multiple courses of steroids
* Chorioamnionitis
* Non reassuring fetal heart rate
* Obstetrical indication of delivery
* Active bleeding
* Pregnancy related hypertensive disorders
* Uncontrolled diabetes

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No