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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04494529
Registration number
NCT04494529
Ethics application status
Date submitted
16/07/2020
Date registered
31/07/2020
Date last updated
23/08/2023
Titles & IDs
Public title
Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth
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Scientific title
Single Dose Antenatal Corticosteroids (SNACS) Pilot Randomized Control Trial for Women at Risk of Preterm Birth
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Secondary ID [1]
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SNACS Pilot Trial
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Universal Trial Number (UTN)
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Trial acronym
SNACS Pilot
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Preterm Birth
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Complication of Prematurity
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Obstetric Labor, Premature
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Obstetric Labor Complications
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Pregnancy Complications
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Condition category
Condition code
Reproductive Health and Childbirth
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Complications of newborn
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Reproductive Health and Childbirth
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Childbirth and postnatal care
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Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - 12 mg betamethasone + placebo
Treatment: Drugs - 24 mg betamethasone
Placebo Comparator: Single-Dose (12 mg betamethasone + placebo) - The standard course of betamethasone consists of 2 intramuscular injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg. Before enrolment and randomization in the SNACS trial, all women will have received a first 12 mg injection of betamethasone according to local hospital protocols. After this first injection, randomization is performed.
Participants randomized to the experimental "Single-Dose" arm will receive a similar appearing placebo injection instead of the standard 2nd dose of 12 mg of betamethasone (i.e. they will receive the experimental single-dose regimen, total 12 mg of betamethasone only from the first injection).
Active Comparator: Double-Dose (12 mg betamethasone + 12 mg betamethasone) - The standard course of betamethasone consists of 2 intramuscular injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg. Before enrolment and randomization in the SNACS trial, all women will have received a first 12 mg injection of betamethasone according to local hospital protocols. After this first injection, randomization is performed.
Participants randomized to the "Double-Dose" arm will receive the standard 2nd dose of 12 mg of betamethasone injected intramuscularly (i.e. they will receive the standard double-dose regimen, total 24 mg of betamethasone).
Treatment: Drugs: 12 mg betamethasone + placebo
After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.
Treatment: Drugs: 24 mg betamethasone
After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Active Comparator" group will receive the standard 2nd intramuscular injection of 12 mg of betamethasone.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Feasibility of conducting a full-scale trial
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Assessment method [1]
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Feasibility of conducting a full-scale trial will be defined as => 50% recruitment of approached participants
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Timepoint [1]
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5-6 months
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Primary outcome [2]
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Feasibility of the study protocol
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Assessment method [2]
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Feasibility of the study intervention will be defined as => 98% compliance with the protocol
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Timepoint [2]
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5-6 months
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Secondary outcome [1]
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Process outcomes
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Assessment method [1]
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The proportions of patients who: will be approached by the circle of care, and will agree to be approached by the research team, and will agree to participate
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Timepoint [1]
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5-6 months
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Secondary outcome [2]
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Neonatal mortality rates
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Assessment method [2]
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Pilot clinical data on neonatal mortality, from medical records
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Timepoint [2]
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5-6 months
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Secondary outcome [3]
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Respiratory morbidity rates
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Assessment method [3]
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Pilot clinical data on respiratory morbidity, from medical records
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Timepoint [3]
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5-6 months
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Secondary outcome [4]
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Severe intraventricular haemorrhage rates
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Assessment method [4]
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Pilot clinical data on severe intraventricular haemorrhage, from medical records
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Timepoint [4]
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5-6 months
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Secondary outcome [5]
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Rates of severe bowel problems due to necrotizing enterocolitis
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Assessment method [5]
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Pilot clinical data on severe bowel problems due to necrotizing enterocolitis, from medical records
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Timepoint [5]
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5-6 months
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Secondary outcome [6]
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Duration of mechanical ventilation requiring an endotracheal tube
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Assessment method [6]
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Pilot clinical data on duration of mechanical ventilation requiring an endotracheal tube, from medical records
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Timepoint [6]
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5-6 months
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Secondary outcome [7]
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Need for supplemental oxygen and duration
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Assessment method [7]
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Pilot clinical data on need for supplemental oxygen and duration, from medical records
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Timepoint [7]
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5-6 months
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Secondary outcome [8]
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Late respiratory morbidity (i.e. bronchopulmonary dysplasia) rates
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Assessment method [8]
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Pilot clinical data on late respiratory morbidity (i.e. bronchopulmonary dysplasia), from medical records
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Timepoint [8]
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5-6 months
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Secondary outcome [9]
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Early neonatal sepsis rates
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Assessment method [9]
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Pilot clinical data on early neonatal sepsis, from medical records
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Timepoint [9]
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5-6 months
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Secondary outcome [10]
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Severe late brain injury (periventricular leukomalacia) rates
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Assessment method [10]
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Pilot clinical data on severe late brain injury (periventricular leukomalacia), from medical records
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Timepoint [10]
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5-6 months
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Secondary outcome [11]
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Intrauterine fetal demise rates
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Assessment method [11]
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Pilot clinical data on intrauterine fetal demise, from medical records
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Timepoint [11]
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5-6 months
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Secondary outcome [12]
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Duration of ventilatory support not requiring an endotracheal tube
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Assessment method [12]
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Pilot clinical data on duration of ventilatory support not requiring an endotracheal tube, from medical records
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Timepoint [12]
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5-6 months
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Secondary outcome [13]
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Rates of hypotension < 48 hours of life requiring treatment with hydrocortisone or inotropic medications
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Assessment method [13]
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Pilot clinical data on hypotension < 48 hours of life requiring treatment with hydrocortisone or inotropic medications, from medical records
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Timepoint [13]
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5-6 months
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Secondary outcome [14]
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Length of stay in neonatal intensive care unit
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Assessment method [14]
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Pilot clinical data on length of stay in neonatal intensive care unit, from medical records
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Timepoint [14]
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5-6 months
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Secondary outcome [15]
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Anthropometry composite (<10% of expected weight, length, or head circumference for birth week)
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Assessment method [15]
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Pilot clinical data on anthropometry (<10% of expected weight, length, or head circumference for birth week), from medical records
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Timepoint [15]
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5-6 months
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Secondary outcome [16]
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Number of infants with retinopathy of prematurity needing treatment
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Assessment method [16]
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Pilot clinical data on retinopathy of prematurity needing treatment, from medical records
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Timepoint [16]
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5-6 months
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Secondary outcome [17]
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Patent ductus arteriosus needing a closure procedure
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Assessment method [17]
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Pilot clinical data on number of infants with patent ductus arteriosus needing a closure procedure, from medical records
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Timepoint [17]
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5-6 months
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Secondary outcome [18]
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24-month follow-up
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Assessment method [18]
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Neurosensory/developmental progress at 24 months corrected gestational age, which will consist principally of 2 validated parent-filled questionnaires:
Ages and Stages Questionnaire-3 (ASQ)
Child Behavior Checklist
A single-question parent report of whether there has been a physician diagnosis of cerebral palsy.
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Timepoint [18]
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18-30 months
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Eligibility
Key inclusion criteria
1. Pregnant women at risk of preterm birth with a singleton or twins between =>22+0/7 and
<=34+6/7 weeks' gestation
2. Pregnant with either singletons or twins
3. Has already received the first dose of 12 mg intramuscular betamethasone within the
past 24 hours
4. All fetuses are alive and without compromise as per ultrasound or fetal heart monitor
5. Is capable of giving informed, written consent in English
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Minimum age
16
Years
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Maximum age
55
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Any contraindications to receiving corticosteroids
2. Requires chronic doses of corticosteroids secondary to a medical condition (e.g.
systemic lupus erythematosus, severe asthma, congenital adrenal hyperplasia, etc.)
3. Received any prior doses of antenatal corticosteroids except for the 1st dose of 12 mg
intramuscular betamethasone
4. Had any previous participation in this trial
5. Pregnant with a fetus with severe congenital anomaly (e.g. anencephaly, transposition
of the great arteries, etc.) or major chromosomal abnormalities (e.g. Trisomy 18,
Trisomy 21, etc.)
6. Pregnant with monoamniotic/monochorionic (Mono/Mono) twins
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/08/2021
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Sample size
Target
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Ontario
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Funding & Sponsors
Primary sponsor type
Other
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Name
McMaster University
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as
respiratory distress syndrome, in preterm infants.
Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone
(for a total of 24 mg) to accelerate fetal lung maturity.
We plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing
half the usual dose (total 12 mg) of betamethasone to the standard double dose (total 24 mg)
of betamethasone.
The results of this pilot will be combined with the full-scale RCT (NCT05114096) for which we
have received funding from the Canadian Institutes of Health Research (CIHR).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04494529
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Sarah D McDonald, MD, MSc, FRCSC
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Address
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McMaster University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04494529
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