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RECRUITING
NCT05114096
PHASE4

Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)

Sponsor: McMaster University

View on ClinicalTrials.gov

Summary

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.

Official title: Single Dose of Antenatal Corticosteroids (SNACS) Randomized Controlled Trial for Pregnancies at Risk of Preterm Delivery: To Keep Babies and Children Safe

Key Details

Gender

FEMALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

3254

Start Date

2023-07-20

Completion Date

2029-12-31

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

DRUG

Celestone + placebo

After the first intramuscular injection of Celestone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.

DRUG

Celestone + Celestone

After the first intramuscular injection of Celestone, participants randomized to the "Active Comparator" group will receive 1 intramuscular injection of Celestone.

Locations (25)

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