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

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
University of Calgary, Cumming School of Medicine
RECRUITING
Calgary
Alberta Health Services; University of Alberta
RECRUITING
Edmonton
Dr. Everett Chalmers Regional Hospital
RECRUITING
Fredericton
Dalhousie University; Izaak Walton Killam Health
RECRUITING
Halifax
McMaster University
RECRUITING
Hamilton
Queen's University, Kingston General Hospital Health Sciences Centre
RECRUITING
Kingston
Western University; London Health Sciences Centre, Victoria Hospital
RECRUITING
London
The Moncton Hospital, Horizon Health Network
RECRUITING
Moncton
McGill University, McGill University Health Center, Royal Victoria Hospital
RECRUITING
Montreal
Sir Mortimer B. Davis Jewish General Hospital; McGill University
NOT_YET_RECRUITING
Montreal
The Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal
RECRUITING
Montreal
Royal Columbian Hospital
NOT_YET_RECRUITING
New Westminster
University of Ottawa; The Ottawa Hospital
RECRUITING
Ottawa
Université Laval, Centre de recherche du CHU de Québec
RECRUITING
Québec
University of Saskatchewan, Regina General Hospital
NOT_YET_RECRUITING
Saskatoon
(CIUSSS de l'Estrie-CHUS); Université de Sherbrooke
RECRUITING
Sherbrooke
Memorial University, Eastern Health
NOT_YET_RECRUITING
St. John's
Fraser Health, University of British Columbia; Jim Pattison Outpatient Care and Surgery Centre
NOT_YET_RECRUITING
Surrey
Mount Sinai Hospital
RECRUITING
Toronto
Sunnybrook Health Sciences Center
RECRUITING
Toronto
University of British Columbia; BC Women's Hospital
NOT_YET_RECRUITING
Vancouver
Victoria General Hospital
NOT_YET_RECRUITING
Victoria
University of Manitoba, Health Sciences Centre
NOT_YET_RECRUITING
Winnipeg
University of Manitoba; St. Boniface General Hospital
NOT_YET_RECRUITING
Winnipeg
Contact Information
Primary
Sarah D McDonald, MD,MSc,FRCSC
mcdonals@mcmaster.ca
905-525-9140
Backup
SNACS Coordinating Centre
SNACS@sunnybrook.ca
Time Frame
Start Date: 2023-07-20
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 3254
Treatments
Experimental: Single-Dose Celestone
Having already received the first dose of Celestone as part of eligibility criteria, participants randomized to the experimental Single-Dose arm will receive a similar appearing placebo injection.
Active_comparator: Double-Dose Celestone
Having already received the first dose of Celestone as part of eligibility criteria, participants randomized to the Double-Dose arm will receive the standard 2nd dose of Celestone injected intramuscularly (i.e. they will receive the standard double-dose regimen).
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Sunnybrook Research Institute, Women's and Children's Hospital, Australia, Hamilton Health Sciences Corporation, University of Adelaide, Medical Research Future Fund
Leads: McMaster University

This content was sourced from clinicaltrials.gov