Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)
Recruiting · NCT05114096 · Interventional (participants receive a specific treatment) · Lead sponsor: McMaster University
View the official record on ClinicalTrials.gov →Interventions studied
Celestone + CelestoneCelestone + placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 55 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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)
- Demise of one or more fetuses after 14 weeks and 0 days
Where it is running
25 locations listed.
- University of Calgary, Cumming School of Medicine - Calgary, Alberta, Canada
- Alberta Health Services; University of Alberta - Edmonton, Alberta, Canada
- Royal Columbian Hospital - New Westminster, British Columbia, Canada
- Fraser Health, University of British Columbia; Jim Pattison Outpatient Care and Surgery Centre - Surrey, British Columbia, Canada
- University of British Columbia; BC Women's Hospital - Vancouver, British Columbia, Canada
- Victoria General Hospital - Victoria, British Columbia, Canada
- University of Manitoba, Health Sciences Centre - Winnipeg, Manitoba, Canada
- University of Manitoba; St. Boniface General Hospital - Winnipeg, Manitoba, Canada
- Dr. Everett Chalmers Regional Hospital - Fredericton, New Brunswick, Canada
- The Moncton Hospital, Horizon Health Network - Moncton, New Brunswick, Canada
- Memorial University, Eastern Health - St. John's, Newfoundland and Labrador, Canada
- Dalhousie University; Izaak Walton Killam Health - Halifax, Nova Scotia, Canada
- McMaster University - Hamilton, Ontario, Canada
- Queen's University, Kingston General Hospital Health Sciences Centre - Kingston, Ontario, Canada
- Western University; London Health Sciences Centre, Victoria Hospital - London, Ontario, Canada
- University of Ottawa; The Ottawa Hospital - Ottawa, Ontario, Canada
- Mount Sinai Hospital - Toronto, Ontario, Canada
- Sunnybrook Health Sciences Center - Toronto, Ontario, Canada
- Hopital Maisonneuve Rosemont, CIUSSS de l'est de l'Ile de Montréal - Montreal, Quebec, Canada
- McGill University, McGill University Health Center, Royal Victoria Hospital - Montreal, Quebec, Canada
- Sir Mortimer B. Davis Jewish General Hospital; McGill University - Montreal, Quebec, Canada
- The Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal - Montreal, Quebec, Canada
- Université Laval, Centre de recherche du CHU de Québec - Québec, Quebec, Canada
- (CIUSSS de l'Estrie-CHUS); Université de Sherbrooke - Sherbrooke, Quebec, Canada
- University of Saskatchewan, Regina General Hospital - Saskatoon, Saskatchewan, Canada