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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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. 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

Treatments Being Tested

DRUG

Celestone + placebo

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

DRUG

Celestone + Celestone

After the first intramuscular injection of Celestone, participants randomized to the "Active Comparator" group will receive 1 intramuscular injection of Celestone.

Locations (20)

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
Fraser Health, University of British Columbia; Jim Pattison Outpatient Care and Surgery Centre
Surrey, British Columbia, Canada
University of British Columbia; BC Women's Hospital
Vancouver, British Columbia, Canada
Victoria General Hospital
Victoria, British Columbia, Canada
University of Manitoba, Health Sciences Centre
Winnipeg, Manitoba, Canada
University of Manitoba; St. Boniface General Hospital
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
McMaster University
Hamilton, Ontario, Canada
Queen's University, Kingston General Hospital Health Sciences Centre
Kingston, Ontario, Canada
Western University; London Health Sciences Centre, Victoria Hospital
London, Ontario, Canada
University of Ottawa; The Ottawa Hospital
Ottawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Hopital Maisonneuve Rosemont, CIUSSS de l'est de l'Ile de Montréal
Montreal, Quebec, Canada
McGill University, McGill University Health Center, Royal Victoria Hospital
Montreal, Quebec, Canada