Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS) - Full Text View

Sponsored by:	Sunnybrook Health Sciences Centre
Information provided by:	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00187382

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 IV

Drug Information available for: Corticosteroids

U.S. FDA Resources

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)

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

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

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	FRN: 38142, ISRCTN72654148
Study First Received:	September 13, 2005
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00187382
Health Authority:	Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:

antenatal corticosteroids
preterm birth
multiple versus single doses
follow-up

Study placed in the following topic categories:

Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Premature Birth

ClinicalTrials.gov processed this record on January 15, 2009