Status:
COMPLETED
Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Pregnancies at Increased Risk of Preterm Birth
Eligibility:
FEMALE
14-45 years
Phase:
PHASE4
Brief Summary
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), d...
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 cour...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
1858 Patients enrolled
Trial Details
Trial ID
NCT00187382
Start Date
April 1 2001
End Date
December 1 2011
Last Update
June 15 2010
Active Locations (1)
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1
Data Coordinating Centre, CMICR 790 Bay Street, 7th Floor
Toronto, Ontario, Canada, M5G 1N8