drugset / Trial / NCT05114096

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.

Timeline

Start
2023-07-20
Primary completion
2026-12-31
Completion
2029-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Betamethasone Other / unclassified 11.4 mg Intramuscular
Comparator Betamethasone Other / unclassified 12 mg Intramuscular

Indications