NCT05114096 Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)
| NCT ID | NCT05114096 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | McMaster University |
| Condition | Preterm Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,254 participants |
| Start Date | 2023-07-20 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 3,254 participants in total. It began in 2023-07-20 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Pregnant people, aged 18 to 55 years old, at risk of preterm birth with a singleton or twins between 22 weeks and 0 days and \<34 weeks and 6 days gestation who have received only a single dose of Celestone within 24 hours 2. Capable of giving informed, written consent. Exclusion Criteria: 1. Contraindication to corticosteroids 2. Systemic corticosteroids for medical conditions during the pregnancy (e.g. lupus, severe asthma, Covid, etc). 3. Previous participation in this trial (in a previous pregnancy) 4. Known severe/life-threatening fetal or pregnant patient condition (e.g. fetal congenital/chromosomal abnormality) 5. Demise of one or more fetuses after 14 weeks and 0 days
Contact & Investigator
Sarah D McDonald, MD,MSc,FRCSC
PRINCIPAL INVESTIGATOR
McMaster University
Frequently Asked Questions
Who can join the NCT05114096 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 55 Years, studying Preterm Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05114096 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05114096 currently recruiting?
Yes, NCT05114096 is actively recruiting participants. Contact the research team at mcdonals@mcmaster.ca for enrollment information.
Where is the NCT05114096 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada, New Westminster, Canada, Surrey, Canada and 11 additional locations.
Who is sponsoring the NCT05114096 clinical trial?
NCT05114096 is sponsored by McMaster University. The principal investigator is Sarah D McDonald, MD,MSc,FRCSC at McMaster University. The trial plans to enroll 3,254 participants.