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

This study has been completed.
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00187382
First received: September 13, 2005
Last updated: June 14, 2010
Last verified: June 2010

September 13, 2005
June 14, 2010
April 2001
June 2007   (final data collection date for primary outcome measure)
  • MACS: Perinatal or neonatal mortality or serious neonatal morbidity
  • MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age
Perinatal or neonatal mortality or serious neonatal morbidity.
Complete list of historical versions of study NCT00187382 on ClinicalTrials.gov Archive Site
  • 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)
Death or neurologic impairment at 2 years of age.
Not Provided
Not Provided
 
Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pregnancies at Increased Risk of Preterm Birth
Drug: Multiple vs. single courses of antenatalcorticosteroids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1858
December 2011
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Female
14 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00187382
FRN: 38142, ISRCTN72654148
Yes
Not Provided
Sunnybrook Health Sciences Centre
Not Provided
Principal Investigator: Kellie Murphy, M.D. Mount Sinai Hospital, New York
Sunnybrook Health Sciences Centre
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP