drugset / Trial / NCT04494529

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

NCT04494529

Phase 3 Completed 30 enrolled McMaster University
RandomizedParallel-groupQuadruple-blindOther

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).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Betamethasone Other / unclassified 12 mg Intramuscular
Comparator Betamethasone Other / unclassified 24 mg Intramuscular

Indications