Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)
- Conditions
- Preterm BirthPregnancy ComplicationsObstetric Labor, PrematureComplication of PrematurityPremature Birth
- Interventions
- Registration Number
- NCT05114096
- Lead Sponsor
- McMaster University
- 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.
- Detailed Description
Preterm infants are at risk of mortality and morbidity. Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome.
The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone to accelerate fetal lung maturity (total 24 mg in Canada, 22.8 mg in Australia). There are no published clinical trial data on the benefits or risks of a single dose of antenatal corticosteroid vs. standard double doses (Ninan et al JOGC 2020).
Pregnant people at 22 weeks and 0 days to \< 34 weeks and 6 days' gestation at risk of preterm birth with a singleton or twin gestation who have received the first dose of Celestone and consented to the trial will be randomized to receive approximately 24 hours later either an experimental placebo injection (of normal saline) or the standard double dose of Celestone to determine whether the intervention is non-inferior for the primary outcome of a composite of perinatal mortality or substantial morbidity.
Please note: Based on Health Canada's' guidance the study phase is 'Other: Off-Label use'. However, on the clincaltrial.gov record, 'Phase 4' is selected as this is the most relevant phase and there is no option to select 'Other'.
Please note: McMaster University, Canada is the Canadian Regulatory Sponsor and Overall Sponsor, and the University of Adelaide Australia is the Australian Sponsor.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 3254
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single-Dose Celestone Celestone + placebo 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. Double-Dose Celestone Celestone + 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).
- Primary Outcome Measures
Name Time Method Perinatal Mortality or Substantial Neonatal Morbidity approximately 1 month 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)
- Secondary Outcome Measures
Name Time Method Death or neurosensory/developmental impairment at 24 months approximately 24 months Death or neurosensory/developmental impairment at 24 months (+/- 6 months; accounting for gestation at birth), mood (anxiety/depression), behavior (aggression), etc as assessed by:
1. Ages and Stages Questionnaire-3 (ASQ)
2. Child Behavior Checklist: 4 subscales
3. Physician diagnosis of cerebral palsy (parent report).
Trial Locations
- Locations (24)
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
University of British Columbia; BC Women's Hospital
🇨🇦Vancouver, British Columbia, Canada
Fraser Health, University of British Columbia; Jim Pattison Outpatient Care and Surgery Centre
🇨🇦Surrey, British Columbia, Canada
Victoria General Hospital
🇨🇦Victoria, British Columbia, Canada
University of Manitoba; St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
University of Manitoba, Health Sciences Centre
🇨🇦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
Western University; London Health Sciences Centre, Victoria Hospital
🇨🇦London, Ontario, Canada
McMaster University
🇨🇦Hamilton, Ontario, Canada
Queen's University, Kingston General Hospital Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
University of Ottawa; The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Sunnybrook Health Sciences Center
🇨🇦Toronto, Ontario, Canada
McGill University, McGill University Health Center, Royal Victoria Hospital
🇨🇦Montréal, Quebec, Canada
Sir Mortimer B. Davis Jewish General Hospital; McGill University
🇨🇦Montréal, Quebec, Canada
The Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal
🇨🇦Montréal, Quebec, Canada
Université Laval, Centre de recherche du CHU de Québec
🇨🇦Québec City, Quebec, Canada
(CIUSSS de l'Estrie-CHUS); Université de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
University of Saskatchewan, Regina General Hospital
🇨🇦Saskatoon, Saskatchewan, Canada