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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05114096




Registration number
NCT05114096
Ethics application status
Date submitted
12/10/2021
Date registered
9/11/2021

Titles & IDs
Public title
Single Dose of Antenatal Corticosteroids for Pregnancies At Risk of Preterm Delivery (SNACS)
Scientific title
Single Dose of Antenatal Corticosteroids (SNACS) Randomized Controlled Trial for Pregnancies At Risk of Preterm Delivery: to Keep Babies and Children Safe
Secondary ID [1] 0 0
3764
Universal Trial Number (UTN)
Trial acronym
SNACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm Birth 0 0
Premature Birth 0 0
Complication of Prematurity 0 0
Obstetric Labor, Premature 0 0
Pregnancy Complications 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Celestone + placebo
Treatment: Drugs - Celestone + Celestone

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).


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

Treatment: Drugs: Celestone + Celestone
After the first intramuscular injection of Celestone, participants randomized to the "Active Comparator" group will receive 1 intramuscular injection of Celestone.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Perinatal Mortality or Substantial Neonatal Morbidity
Timepoint [1] 0 0
approximately 1 month
Secondary outcome [1] 0 0
Death or neurosensory/developmental impairment at 24 months
Timepoint [1] 0 0
approximately 24 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
3254
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [2] 0 0
The University of Newcastle - Newcastle
Recruitment hospital [3] 0 0
The Royal Hospital for Women - Randwick
Recruitment hospital [4] 0 0
The University of New South Wales, St George Hospital - Sydney
Recruitment hospital [5] 0 0
University of Sydney; Westmead Institute for Maternal Fetal Medicine, Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [7] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [8] 0 0
University of Queensland and Ipswich Hospital - Ipswich
Recruitment hospital [9] 0 0
Mater Centre for Maternal Fetal Medicine - South Brisbane
Recruitment hospital [10] 0 0
The University of Queensland; Mater Research Institute/University of Queensland - South Brisbane
Recruitment hospital [11] 0 0
Townsville Hospital and Health Services - Townsville
Recruitment hospital [12] 0 0
University of Adelaide; Women's & Children's Hospital - North Adelaide
Recruitment hospital [13] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [14] 0 0
Moorabbin Hospital, Monash Health - Clayton
Recruitment hospital [15] 0 0
University of Melbourne; Mercy Hospital for Women - Heidelberg
Recruitment hospital [16] 0 0
The Royal Women's Hospital; University of Melbourne - Parkville
Recruitment hospital [17] 0 0
The University of Melbourne; Joan Kirner Women's & Children's Sunshine Hospital - Saint Albans
Recruitment postcode(s) [1] 0 0
- Newcastle
Recruitment postcode(s) [2] 0 0
- Randwick
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment postcode(s) [5] 0 0
- Tiwi
Recruitment postcode(s) [6] 0 0
- Herston
Recruitment postcode(s) [7] 0 0
- Ipswich
Recruitment postcode(s) [8] 0 0
- South Brisbane
Recruitment postcode(s) [9] 0 0
- Townsville
Recruitment postcode(s) [10] 0 0
- North Adelaide
Recruitment postcode(s) [11] 0 0
- Hobart
Recruitment postcode(s) [12] 0 0
- Clayton
Recruitment postcode(s) [13] 0 0
- Heidelberg
Recruitment postcode(s) [14] 0 0
- Parkville
Recruitment postcode(s) [15] 0 0
- Saint Albans
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
New Brunswick
Country [5] 0 0
Canada
State/province [5] 0 0
Newfoundland and Labrador
Country [6] 0 0
Canada
State/province [6] 0 0
Nova Scotia
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Canada
State/province [9] 0 0
Saskatchewan

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Hamilton Health Sciences Corporation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Sunnybrook Research Institute
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Women's and Children's Hospital, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
Canadian Institutes of Health Research (CIHR)
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Medical Research Future Fund
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University of Adelaide
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sarah D McDonald, MD,MSc,FRCSC
Address 0 0
McMaster University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah D McDonald, MD,MSc,FRCSC
Address 0 0
Country 0 0
Phone 0 0
905-525-9140
Fax 0 0
Email 0 0
mcdonals@mcmaster.ca
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
An IPD is planned with trial leaders of another half dose Celestone study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05114096