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Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth

NCT04494529 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-08-23

No results posted yet for this study

Summary

Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome, in preterm infants.

Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone (for a total of 24 mg) to accelerate fetal lung maturity.

We plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose (total 12 mg) of betamethasone to the standard double dose (total 24 mg) of betamethasone.

The results of this pilot will be combined with the full-scale RCT (NCT05114096) for which we have received funding from the Canadian Institutes of Health Research (CIHR).

Conditions

  • Preterm Birth
  • Complication of Prematurity
  • Obstetric Labor, Premature
  • Obstetric Labor Complications
  • Pregnancy Complications

Interventions

DRUG

12 mg betamethasone + placebo

After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.

DRUG

24 mg betamethasone

After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Active Comparator" group will receive the standard 2nd intramuscular injection of 12 mg of betamethasone.

Sponsors & Collaborators

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
16 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04494529 on ClinicalTrials.gov