CompletedPhase 4

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

Canada1,858 participantsStarted 2001-04

Plain-language 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), 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.

Who can participate

Age range14 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

MACS: Perinatal or neonatal mortality or serious neonatal morbidity

MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age

Trial details

NCT IDNCT00187382

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-06

View on ClinicalTrials.gov More Pregnancies at Increased Risk of Preterm Birth trials