Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)
- Conditions
- Pregnancies at Increased Risk of Preterm Birth
- Registration Number
- NCT00187382
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1858
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method MACS: Perinatal or neonatal mortality or serious neonatal morbidity MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
Data Coordinating Centre, CMICR 790 Bay Street, 7th Floor
🇨🇦Toronto, Ontario, Canada