Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)

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

Interventions

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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation

  collaborator OTHER

• Sunnybrook Research Institute

  collaborator OTHER

• Women's and Children's Hospital, Australia

  collaborator OTHER_GOV

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Medical Research Future Fund

  collaborator OTHER

• University of Adelaide

  collaborator OTHER

• McMaster University

  lead OTHER

Principal Investigators

• Sarah D McDonald, MD,MSc,FRCSC · McMaster University

• Kellie Murphy, MD,MSc,FRCSC · University of Toronto

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-20

Primary Completion

2026-12-31

Completion

2029-12-31

Countries

• Canada

Study Locations