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 range

14 Years – 45 Years

Sex

FEMALE

See this in plain English?

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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