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

3,254 Participants
are divided into 2 treatment groups

Locations

25
Alberta
University of Calgary, Cumming School of Medicine Calgary Canada
Alberta Health Services; University of Alberta Edmonton Canada
British Columbia
Royal Columbian Hospital New Westminster Canada
Fraser Health, University of British Columbia; Jim Pattison Outpatient Care and Surgery Centre Surrey Canada

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