Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)
SNACS
1 other identifier
interventional
3,254
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2023
Longer than P75 for phase_4
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2021
CompletedFirst Posted
Study publicly available on registry
November 9, 2021
CompletedStudy Start
First participant enrolled
July 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
January 7, 2026
September 1, 2025
3.5 years
October 12, 2021
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Perinatal Mortality or Substantial Neonatal Morbidity
Fetal death post-randomization or in hospital neonatal death OR =\> 1 of respiratory morbidity (requiring surfactant \<=48 hrs of life), severe intraventricular hemorrhage (distending/beyond the ventricles, i.e. Grade 3 or 4), or severe bowel problem (necrotizing enterocolitis, Stage 2 or 3)
approximately 1 month
Secondary Outcomes (1)
Death or neurosensory/developmental impairment at 24 months
approximately 24 months
Other Outcomes (17)
Number of babies who received intubation and duration of invasive mechanical ventilation
approximately up to first 6 months of life
Number of babies who received, and duration of, supplemental oxygen (after resuscitation) and other ventilatory support
approximately up to first 6 months of life
Number of babies with respiratory distress after the initial resuscitation/stabilization and main cause
approximately 1 month
- +14 more other outcomes
Study Arms (2)
Single-Dose Celestone
EXPERIMENTALHaving 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.
Double-Dose Celestone
ACTIVE COMPARATORHaving 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).
Interventions
After the first intramuscular injection of Celestone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.
After the first intramuscular injection of Celestone, participants randomized to the "Active Comparator" group will receive 1 intramuscular injection of Celestone.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical Research Future Fundcollaborator
- University of Adelaidecollaborator
- McMaster Universitylead
- Hamilton Health Sciences Corporationcollaborator
- Sunnybrook Research Institutecollaborator
- Women's and Children's Hospital, Australiacollaborator
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (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, H1T 2M4, 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
Related Publications (1)
Ninan K, Morfaw F, Murphy KE, Beyene J, McDonald SD. Neonatal and Maternal Outcomes of Lower Versus Standard Doses of Antenatal Corticosteroids for Women at Risk of Preterm Delivery: A Systematic Review of Randomized Controlled Trials. J Obstet Gynaecol Can. 2021 Jan;43(1):74-81. doi: 10.1016/j.jogc.2020.02.127. Epub 2020 Mar 26.
PMID: 32660867BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah D McDonald, MD,MSc,FRCSC
McMaster University
- PRINCIPAL INVESTIGATOR
Kellie Murphy, MD,MSc,FRCSC
University of Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2021
First Posted
November 9, 2021
Study Start
July 20, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2029
Last Updated
January 7, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
An IPD is planned with trial leaders of another half dose Celestone study.