Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00187382|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Pregnancies at Increased Risk of Preterm Birth||Drug: Multiple vs. single courses of antenatalcorticosteroids||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1858 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)|
|Study Start Date :||April 2001|
|Actual Primary Completion Date :||June 2007|
|Study Completion Date :||December 2011|
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187382
|Data Coordinating Centre, CMICR 790 Bay Street, 7th Floor|
|Toronto, Ontario, Canada, M5G 1N8|
|Principal Investigator:||Kellie Murphy, M.D.||MOUNT SINAI HOSPITAL|