drugset / Trial / NCT05114096
Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)
Phase 4
Recruiting
3254 enrolled
McMaster University
Canadian Institutes of Health Research (CIHR) · collabHamilton Health Sciences Corporation · collabMedical Research Future Fund · collabSunnybrook Research Institute · collabUniversity of Adelaide · collabWomen's and Children's Hospital, Australia · collab
RandomizedParallel-groupQuadruple-blindOther
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Betamethasone | Other / unclassified | 11.4 mg | Intramuscular |
| Comparator | Betamethasone | Other / unclassified | 12 mg | Intramuscular |