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RecruitingPhase 4NCT05114096

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

Sponsor

McMaster University

Enrollment

3,254 participants

Start Date

Jul 20, 2023

Study Type

INTERVENTIONAL

Conditions

Pregnancy ComplicationsPremature BirthObstetric Labor, PrematurePreterm BirthComplication of Prematurity

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Inclusion Criteria2

  • 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.

Exclusion Criteria5

  • 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

Interventions

DRUGCelestone + placebo

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

DRUGCelestone + Celestone

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

Locations(25)

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

Sir Mortimer B. Davis Jewish General Hospital; McGill University

Montreal, Quebec, Canada

The Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal

Montreal, Quebec, Canada

Université Laval, Centre de recherche du CHU de Québec

Québec, Quebec, Canada

(CIUSSS de l'Estrie-CHUS); Université de Sherbrooke

Sherbrooke, Quebec, Canada

University of Saskatchewan, Regina General Hospital

Saskatoon, Saskatchewan, Canada

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NCT05114096

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