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
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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:
  • 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)

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)
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.

  Eligibility

Ages Eligible for Study:   14 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187382

Locations
Canada, Ontario
Data Coordinating Centre, CMICR 790 Bay Street, 7th Floor
Toronto, Ontario, Canada, M5G 1N8
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Kellie Murphy, M.D. Mount Sinai Hospital, New York
  More Information

Additional Information:
No publications provided by Sunnybrook Health Sciences Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00187382     History of Changes
Other Study ID Numbers: FRN: 38142, ISRCTN72654148
Study First Received: September 13, 2005
Last Updated: June 14, 2010
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
antenatal corticosteroids
preterm birth
multiple versus single doses
follow-up

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on July 24, 2014