Antenatal Corticosteroids for Premature Birth
(SNACS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities in preterm infants, such as respiratory distress syndrome.The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone (for a total of 24 mg in Canada, or 22.8 mg in Australia) to accelerate fetal lung maturity.The investigators plan to conduct a randomized controlled trial to determine whether half the usual dose (12 mg in Canada, or 11.4 mg in Australia) of Celestone is non-inferior to the standard double doses.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are taking systemic corticosteroids for medical conditions during pregnancy, you cannot participate.
How does the drug Celestone differ from other treatments for premature birth?
Celestone (betamethasone) is unique for premature birth as it is a corticosteroid that helps mature the baby's lungs before birth, reducing complications. Unlike other treatments, it is specifically used to accelerate lung development in preterm infants, which is crucial for their survival and health.12345
What data supports the effectiveness of the drug Celestone, Betamethasone, Celestone Soluspan for premature birth?
Research shows that betamethasone, a component of the drug, has anti-inflammatory effects and is used in other treatments like psoriasis, suggesting it may help reduce inflammation in various conditions. However, there is no direct evidence from the provided studies about its effectiveness specifically for premature birth.12678
Who Is on the Research Team?
Sarah D McDonald, MD,MSc,FRCSC
Principal Investigator
McMaster University
Kellie Murphy, MD,MSc,FRCSC
Principal Investigator
University of Toronto
Are You a Good Fit for This Trial?
This trial is for pregnant individuals aged 18-55 at risk of preterm birth between 22 and <35 weeks gestation, who can give informed consent and have received only one dose of Celestone within the last 24 hours. It's not for those on systemic corticosteroids, with severe fetal/patient conditions, or previous trial participation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a placebo or the standard double dose of Celestone to determine non-inferiority for the primary outcome
Follow-up
Participants are monitored for safety and effectiveness after treatment, including neonatal outcomes and long-term health assessments
What Are the Treatments Tested in This Trial?
Interventions
- Celestone
Celestone is already approved in Canada, United States, European Union for the following indications:
- Preterm labor
- Respiratory distress syndrome prevention
- Preterm labor
- Respiratory distress syndrome prevention
- Preterm labor
- Respiratory distress syndrome prevention
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor
Sunnybrook Research Institute
Collaborator
Women's and Children's Hospital, Australia
Collaborator
Medical Research Future Fund
Collaborator
University of Adelaide
Collaborator
Hamilton Health Sciences Corporation
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Medical Research Future Fund
Collaborator