NCT00187382

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,858 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Female
• Age: 14 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancies at Increased Risk of Preterm Birth

Interventions

Type	Name	Description
DRUG	Multiple vs. single courses of antenatalcorticosteroids

Timeline

• Start date: 2001-04-01
• Primary completion: 2007-06-01
• Completion: 2011-12-01
• First posted: 2005-09-16
• Last updated: 2010-06-15

Locations

1 site across 1 country: Canada