Pregnancies at Increased Risk of Preterm Birth Clinical Trial
Official title:
Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention