Recruiting

Antenatal Corticosteroids

Sponsor:

McMaster University

Code:

NCT05114096

Conditions

Preterm Birth

Premature Birth

Complication of Prematurity

Obstetric Labor, Premature

Pregnancy Complications

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Celestone + placebo

Celestone + Celestone

Study Details

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.

Conditions

Preterm Birth

Premature Birth

Complication of Prematurity

Obstetric Labor, Premature

Pregnancy Complications

Study ID

NCT05114096

Start date

Jul 20, 2023

Status verified date

Sep, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

3254 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Single-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.

active comparator: Double-Dose 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).

Interventions

Celestone + placebo

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

Celestone + Celestone

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

Primary outcome measure

  • Perinatal Mortality or Substantial Neonatal Morbidity [ Time Frame: approximately 1 month ]

Central Contacts and Locations

Central contacts

Sarah D McDonald, MD,MSc,FRCSC

905-525-9140mcdonals@mcmaster.ca

SNACS Coordinating Centre

SNACS@sunnybrook.ca

Locations

University of Calgary, Cumming School of Medicine

Recruiting

Calgary, Alberta, Canada

Alberta Health Services; University of Alberta

Recruiting

Edmonton, Alberta, Canada

Dr. Everett Chalmers Regional Hospital

Recruiting

Fredericton, New Brunswick, Canada

The Moncton Hospital, Horizon Health Network

Recruiting

Moncton, New Brunswick, Canada

Dalhousie University; Izaak Walton Killam Health

Recruiting

Halifax, Nova Scotia, Canada

McMaster University

Recruiting

Hamilton, Ontario, Canada

Queen's University, Kingston General Hospital Health Sciences Centre

Recruiting

Kingston, Ontario, Canada

Western University; London Health Sciences Centre, Victoria Hospital

Recruiting

London, Ontario, Canada

University of Ottawa; The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada

Sunnybrook Health Sciences Center

Recruiting

Toronto, Ontario, Canada

Hopital Maisonneuve Rosemont, CIUSSS de l'est de l'Ile de Montréal

Recruiting

Montreal, Quebec, Canada, H1T 2M4

McGill University, McGill University Health Center, Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada

The Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal

Recruiting

Montreal, Quebec, Canada

Université Laval, Centre de recherche du CHU de Québec

Recruiting

Québec, Quebec, Canada

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

Recruiting

Sherbrooke, Quebec, Canada

More Information

Sponsor

McMaster University

Last update posted

Jan 7, 2026

Last verified

Sep, 2025

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2026-01-07.