Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1858 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2011-12-31

Brief Summary

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In women at 26 to 30 weeks gestation and who are risk for threatened early birth, who have not had their baby by 14 or more days after being given a single course of antenatal corticosteroids (ACS), do repeated courses of ACS every 14 days until 33 weeks' gestational age lower the risk of illness or death in babies compared to repeated courses of placebo. Children are assessed at 2 years and 5 years for neurodevelopmental impairment.

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Detailed Description

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In women at 26 to 30 weeks gestation, who are at increased risk for preterm birth and remain undelivered 14 or more days following a single course of antenatal corticosteroids (ACS), are multiple course of ACS every 14 days until 33 weeks effective in reducing the risk of perinatal or neonatal mortality or significant neonatal morbidity, compared to placebo.

18-24 Month Follow-up: Children (18-24 months corrected gestational age) are assessed with the Bayley Scales of Infant Development (Second Edition) to determine neurodevelopmental impairment.

5 Year Follow-up (MACS-5): Children are assessed using the Child Behaviour Checklist (1 1/2 - 5) and the Behaviour Rating Inventory of Executive Function (Preschool version) to determine neurocognitive function.

Conditions

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Pregnancies at Increased Risk of Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Multiple vs. single courses of antenatalcorticosteroids

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women who have previously received one completed course of ACS, at least 14 days ago and continue to be at increased risk of preterm birth
* Gestational age greater ≥ 26 weeks and gestational age \< 31 weeks

Exclusion Criteria

* Women requiring chronic doses of corticosteroids secondary to medical conditions
* Women with a contraindication to corticosteroids
* Women with clinical evidence of chorioamnionitis (temperature ≥ 38°c)
* Known lethal congenital anomaly (e.g. anencephaly)

Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No