Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Complication of Prematurity
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Pregnancy Complications
- Preterm Birth
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Pilot double-blind randomized controlled trialMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Other
Participation Requirements
- Age
- Between 16 years and 55 years
- Gender
- Only males
Description
Preterm infants are at risk of mortality and morbidity. Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome. Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone (for a total of 24 mg) to acc...
Preterm infants are at risk of mortality and morbidity. Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome. 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. There are no published clinical trial data on the benefits or risks of a single dose of antenatal corticosteroid vs. standard double doses. Pilot trials are now viewed as an "almost essential prerequisite" to large, expensive, full scale studies. Thus, we plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose (12 mg of betamethasone + placebo) to the standard double dose (12 mg + 12 mg of betamethasone), as well as the feasibility of the study protocol. Secondary outcomes will include process outcomes, clinical outcomes, maternal experiences, and provider outcomes.
Tracking Information
- NCT #
- NCT04494529
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Sarah D McDonald, MD, MSc, FRCSC McMaster University Principal Investigator: Kellie Murphy, MD, MSc, FRCSC University of Toronto
Get Well Soon