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.
Pregnancies at Increased Risk of Preterm Birth
Drug: Multiple vs. single courses of antenatalcorticosteroids
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)|
- MACS: Perinatal or neonatal mortality or serious neonatal morbidity
- MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age
- MACS: Death or neurologic impairment at 2 years of age
- MACS-5: Measures of growth and blood pressure assessed by clinical exam
- MACS-5: At Canadian sites, abnormalities in intelligence and specific cognitive skills (WPPSI-III, Beery: VMI and PPVT-III)
|Study Start Date:||April 2001|
|Estimated Study Completion Date:||December 2011|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187382
|Data Coordinating Centre, CMICR 790 Bay Street, 7th Floor|
|Toronto, Ontario, Canada, M5G 1N8|
|Principal Investigator:||Kellie Murphy, M.D.||Mount Sinai Hospital, New York|