Testing Celestone + Celestone for preterm birth
Official title: Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)
Single Dose of Antenatal Corticosteroids (SNACS) Randomized Controlled Trial for Pregnancies at Risk of Preterm Delivery: To Keep Babies and Children Safe
- Phase 4
- 2 groups
- Sites in Calgary, Edmonton and 18 more cities
- Recruiting
Interventions
- Medication
Celestone + placebo
After the first intramuscular injection of Celestone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.
- Medication
Celestone + Celestone
After the first intramuscular injection of Celestone, participants randomized to the "Active Comparator" group will receive 1 intramuscular injection of Celestone.
Canadian Sites (25)
16 of 25 recruiting
- Recruiting
University of Calgary, Cumming School of Medicine
Calgary, Alberta
- Recruiting
Alberta Health Services; University of Alberta
Edmonton, Alberta
- Recruiting
Dr. Everett Chalmers Regional Hospital
Fredericton, New Brunswick
- Recruiting
The Moncton Hospital, Horizon Health Network
Moncton, New Brunswick
- Recruiting
Dalhousie University; Izaak Walton Killam Health
Halifax, Nova Scotia
- Recruiting
McMaster University
Hamilton, Ontario
- Recruiting
Queen's University, Kingston General Hospital Health Sciences Centre
Kingston, Ontario
- Recruiting
Western University; London Health Sciences Centre, Victoria Hospital
London, Ontario
- Recruiting
University of Ottawa; The Ottawa Hospital
Ottawa, Ontario
- Recruiting
Mount Sinai Hospital
Toronto, Ontario
- Recruiting
Sunnybrook Health Sciences Center
Toronto, Ontario
- Recruiting
Hopital Maisonneuve Rosemont, CIUSSS de l'est de l'Ile de Montréal
Montreal, Quebec
- Recruiting
McGill University, McGill University Health Center, Royal Victoria Hospital
Montreal, Quebec
- Recruiting
The Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal
Montreal, Quebec
- Recruiting
Université Laval, Centre de recherche du CHU de Québec
Québec, Quebec
- Recruiting
(CIUSSS de l'Estrie-CHUS); Université de Sherbrooke
Sherbrooke, Quebec
- Not yet recruiting
Royal Columbian Hospital
New Westminster, British Columbia
- Not yet recruiting
Fraser Health, University of British Columbia; Jim Pattison Outpatient Care and Surgery Centre
Surrey, British Columbia
- Not yet recruiting
University of British Columbia; BC Women's Hospital
Vancouver, British Columbia
- Not yet recruiting
Victoria General Hospital
Victoria, British Columbia
- Not yet recruiting
University of Manitoba, Health Sciences Centre
Winnipeg, Manitoba
- Not yet recruiting
University of Manitoba; St. Boniface General Hospital
Winnipeg, Manitoba
- Not yet recruiting
Memorial University, Eastern Health
St. John's, Newfoundland and Labrador
- Not yet recruiting
Sir Mortimer B. Davis Jewish General Hospital; McGill University
Montreal, Quebec
- Not yet recruiting
University of Saskatchewan, Regina General Hospital
Saskatoon, Saskatchewan
Eligibility Criteria
See who this study is looking for7 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
Exclusion
- −Contraindication to corticosteroids
- −Demise of one or more fetuses after 14 weeks and 0 days
- −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)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
Phase 4Phase 4A study of a treatment that is already approved and in use.Read more → — a study of a treatment already approved for use, following it in everyday practice.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Celestone + placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
Registry label: A: Single-Dose Celestone
Group B, the comparison group, receives Celestone + Celestone.
Registry label: B: Double-Dose Celestone
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it — alongside the other treatment that group is given.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 55 years.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 3,254 people.
The study is currently expected to finish around December 2029.
The main measurement is taken over: approximately 1 month.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Perinatal Mortality or Substantial Neonatal Morbidity — measured over approximately 1 month.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05114096 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Celestone + placeboDrug
After the first intramuscular injection of Celestone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Celestone + CelestoneDrug
After the first intramuscular injection of Celestone, participants randomized to the "Active Comparator" group will receive 1 intramuscular injection of Celestone.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 55 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it — alongside the other treatment that group is given.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 55 years.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: approximately 1 month.
The study as a whole is currently expected to finish around 2029-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 3,254 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 20 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; New Westminster, British Columbia, Canada; Surrey, British Columbia, Canada; Vancouver, British Columbia, Canada; Victoria, British Columbia, Canada, and 14 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.