About 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.
Eligibility criteria
Qualifiers
Pregnant people, aged 18 to 55 years old, at risk of preterm birth with a singleton or twins between 22 weeks and 0 days and <34 weeks and 6 days gestation who have received only a single dose of Celestone within 24 hours
Capable of giving informed, written consent.
Disqualifiers
Contraindication to corticosteroids
Systemic corticosteroids for medical conditions during the pregnancy (e.g. lupus, severe asthma, Covid, etc).
Previous participation in this trial (in a previous pregnancy)
Known severe/life-threatening fetal or pregnant patient condition (e.g. fetal congenital/chromosomal abnormality)
Trial design
Treatments tested in this trial
- Celestone + placebo
- Celestone + Celestone
Treatment groups
Sponsors and collaborators
McMaster University
Lead sponsor
Hamilton Health Sciences Corporation
Collaborator
Sunnybrook Research Institute
Collaborator
Women's and Children's Hospital, Australia
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Medical Research Future Fund
Collaborator
University of Adelaide
Collaborator