Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS) (SNACS)
Preterm Birth, Premature Birth, Complication of Prematurity
About this trial
This is an interventional other trial for Preterm Birth focused on measuring Premature birth, Preterm birth, Obstetric labour, Betamethasone, Betamethasone Valerate, Betamethasone-17,21-dipropionate, Betamethasone benzoate, Betamethasone sodium phosphate, Anti-Inflammatory Agents, Glucocorticoids, Hormones, Hormones, Hormone Substitutes and Hormone Antagonists, Physiological Effect of Drugs, Anti-Asthmatic Agents, Respiratory System Agents
Eligibility Criteria
Inclusion Criteria:
- 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
- All fetuses must be without compromise as per ultrasound or fetal heart rate monitor (so that waiting 24 hours for the study medication is acceptable).
- Capable of giving informed, written consent.
Exclusion Criteria:
- 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
Sites / Locations
- John Hunter Hospital
- The University of Newcastle
- The Royal Hospital for Women
- The University of New South Wales, St George Hospital
- University of Sydney; Westmead Institute for Maternal Fetal Medicine, Westmead Hospital
- Royal Darwin Hospital
- Royal Brisbane & Women's Hospital
- University of Queensland and Ipswich Hospital
- Mater Centre for Maternal Fetal Medicine
- The University of Queensland; Mater Research Institute/University of Queensland
- Townsville Hospital and Health Services
- University of Adelaide; Women's & Children's Hospital
- Royal Hobart Hospital
- Moorabbin Hospital, Monash Health
- University of Melbourne; Mercy Hospital for Women
- The Royal Women's Hospital; University of Melbourne
- The University of Melbourne; Joan Kirner Women's & Children's Sunshine Hospital
- University of Calgary, Cumming School of Medicine
- Alberta Health Services; University of Alberta
- Royal Columbian Hospital
- Fraser Health, University of British Columbia; Jim Pattison Outpatient Care and Surgery Centre
- University of British Columbia; BC Women's Hospital
- Victoria General Hospital
- University of Manitoba, Health Sciences Centre
- University of Manitoba; St. Boniface General Hospital
- Dr. Everett Chalmers Regional Hospital
- The Moncton Hospital, Horizon Health Network
- Memorial University, Eastern Health
- Dalhousie University
- McMaster University
- Queen's University, Kingston General Hospital Health Sciences Centre
- Western University; London Health Sciences Centre, Victoria Hospital
- University of Ottawa; The Ottawa Hospital
- Mount Sinai Hospital
- Sunnybrook Health Sciences Center
- McGill University, McGill University Health Center, Royal Victoria Hospital
- Sir Mortimer B. Davis Jewish General Hospital; McGill University
- The Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal
- Université Laval, Centre de recherche du CHU de Québec
- (CIUSSS de l'Estrie-CHUS); Université de Sherbrooke
- University of Saskatchewan, Regina General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Single-Dose Celestone
Double-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.
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).