NCT04494529

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

Single Dose Antenatal Corticosteroids (SNACS) Pilot Randomized Control Trial for Women at Risk of Preterm Birth

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: Female
• Age: 16 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 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 and pilot clinical outcomes, that will be combined with the full-scale RCT for which we have received funding from CIHR. We plan to conduct a 24-month corrected gestational age follow-up, which will consist principally of 2 validated parent-filled questionnaires: 1. Ages and Stages Questionnaire-3 (ASQ) 2. Child Behavior Checklist 3. A single question parent report of whether there has been a physician diagnosis of cerebral palsy. (recommended by our parent partners)

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-08-31
• Completion: 2021-08-31
• First posted: 2020-07-31
• Last updated: 2023-08-23

Locations

1 site across 1 country: Canada