Pregnancies at Increased Risk of Preterm Birth Clinical Trial
Official title:
Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)
| Verified date | June 2010 |
| Source | Sunnybrook Health Sciences Centre |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1858 |
| Est. completion date | December 2011 |
| Est. primary completion date | June 2007 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 14 Years to 45 Years |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Canada | Data Coordinating Centre, CMICR 790 Bay Street, 7th Floor | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Sunnybrook Health Sciences Centre |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | MACS: Perinatal or neonatal mortality or serious neonatal morbidity | |||
| Primary | MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age | |||
| Secondary | MACS: Death or neurologic impairment at 2 years of age | |||
| Secondary | MACS-5: Measures of growth and blood pressure assessed by clinical exam | |||
| Secondary | MACS-5: At Canadian sites, abnormalities in intelligence and specific cognitive skills (WPPSI-III, Beery: VMI and PPVT-III) |