Single dose of corticosteroids for pregnant individuals at risk of preterm delivery
Single Dose of Antenatal Corticosteroids (SNACS) Randomized Controlled Trial for Pregnancies at Risk of Preterm Delivery: To Keep Babies and Children Safe
This study is testing if a single lower dose of a corticosteroid can help pregnant people at risk of preterm delivery have healthier babies compared to the usual double dose.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 3254 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | McMaster University Academic / other |
| Locations | 25 sites (Calgary, Alberta and 24 other locations) |
| Trial ID | NCT05114096 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether a single lower dose of Celestone, an antenatal corticosteroid, is as effective as the standard double dose in reducing neonatal death and morbidity in preterm infants. Pregnant individuals between 22 weeks and less than 34 weeks of gestation who are at risk of preterm birth will be randomized to receive either the standard double dose or a placebo after having received an initial dose of Celestone. The primary outcome will assess the rates of perinatal mortality and substantial morbidity. This study aims to provide evidence on the efficacy of a single dose compared to the standard treatment.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals aged 18 to 55 years, carrying a singleton or twin gestation, between 22 weeks and less than 34 weeks of gestation, who have received a single dose of Celestone.
Not a fit: Patients with contraindications to corticosteroids or those requiring systemic corticosteroids for other medical conditions during pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could simplify treatment protocols and reduce medication exposure for pregnant individuals at risk of preterm delivery.
How similar studies have performed: While there is limited published data on the single dose of antenatal corticosteroids, the approach of using lower doses has shown promise in other studies, making this a potentially novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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 2. Capable of giving informed, written consent. Exclusion Criteria: 1. Contraindication to corticosteroids 2. Systemic corticosteroids for medical conditions during the pregnancy (e.g. lupus, severe asthma, Covid, etc). 3. Previous participation in this trial (in a previous pregnancy) 4. Known severe/life-threatening fetal or pregnant patient condition (e.g. fetal congenital/chromosomal abnormality) 5. Demise of one or more fetuses after 14 weeks and 0 days
Where this trial is running
Calgary, Alberta and 24 other locations
- University of Calgary, Cumming School of Medicine — Calgary, Alberta, Canada (Recruiting)
- Alberta Health Services; University of Alberta — Edmonton, Alberta, Canada (Recruiting)
- Royal Columbian Hospital — New Westminster, British Columbia, Canada (Not_yet_recruiting)
- Fraser Health, University of British Columbia; Jim Pattison Outpatient Care and Surgery Centre — Surrey, British Columbia, Canada (Not_yet_recruiting)
- University of British Columbia; BC Women's Hospital — Vancouver, British Columbia, Canada (Not_yet_recruiting)
- Victoria General Hospital — Victoria, British Columbia, Canada (Not_yet_recruiting)
- University of Manitoba, Health Sciences Centre — Winnipeg, Manitoba, Canada (Not_yet_recruiting)
- University of Manitoba; St. Boniface General Hospital — Winnipeg, Manitoba, Canada (Not_yet_recruiting)
- Dr. Everett Chalmers Regional Hospital — Fredericton, New Brunswick, Canada (Recruiting)
- The Moncton Hospital, Horizon Health Network — Moncton, New Brunswick, Canada (Recruiting)
- Memorial University, Eastern Health — St. John's, Newfoundland and Labrador, Canada (Not_yet_recruiting)
- Dalhousie University; Izaak Walton Killam Health — Halifax, Nova Scotia, Canada (Recruiting)
- McMaster University — Hamilton, Ontario, Canada (Recruiting)
- Queen's University, Kingston General Hospital Health Sciences Centre — Kingston, Ontario, Canada (Recruiting)
- Western University; London Health Sciences Centre, Victoria Hospital — London, Ontario, Canada (Recruiting)
- University of Ottawa; The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
- Sunnybrook Health Sciences Center — Toronto, Ontario, Canada (Recruiting)
- Hopital Maisonneuve Rosemont, CIUSSS de l'est de l'Ile de Montréal — Montreal, Quebec, Canada (Recruiting)
- McGill University, McGill University Health Center, Royal Victoria Hospital — Montreal, Quebec, Canada (Recruiting)
- Sir Mortimer B. Davis Jewish General Hospital; McGill University — Montreal, Quebec, Canada (Not_yet_recruiting)
- The Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal — Montreal, Quebec, Canada (Recruiting)
- Université Laval, Centre de recherche du CHU de Québec — Québec, Quebec, Canada (Recruiting)
- (CIUSSS de l'Estrie-CHUS); Université de Sherbrooke — Sherbrooke, Quebec, Canada (Recruiting)
- University of Saskatchewan, Regina General Hospital — Saskatoon, Saskatchewan, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Sarah D McDonald, MD,MSc,FRCSC — McMaster University
- Study coordinator: Sarah D McDonald, MD,MSc,FRCSC
- Email: mcdonals@mcmaster.ca
- Phone: 905-525-9140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.