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Sponsored by: |
Sunnybrook Health Sciences Centre |
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Information provided by: | Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT00187382 |
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.
Condition | Intervention | Phase |
---|---|---|
Pregnancies at Increased Risk of Preterm Birth |
Drug: Multiple vs. single courses of antenatalcorticosteroids |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS) |
Enrollment: | 1858 |
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.
Ages Eligible for Study: | 14 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Data Coordinating Centre, CMICR 790 Bay Street, 7th Floor | |
Toronto, Ontario, Canada, M5G 1N8 |
Principal Investigator: | Kellie Murphy, M.D. | MOUNT SINAI HOSPITAL |
Study ID Numbers: | FRN: 38142, ISRCTN72654148 |
Study First Received: | September 13, 2005 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00187382 History of Changes |
Health Authority: | Canada: Health Canada |
antenatal corticosteroids preterm birth multiple versus single doses follow-up |
Pregnancy Complications Obstetric Labor, Premature Obstetric Labor Complications Premature Birth |
Pregnancy Complications Obstetric Labor, Premature Obstetric Labor Complications Premature Birth |