Ignite Creation Date:
2024-05-06 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05114096
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2021-10-12
Brief Title:
Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery SNACS
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Single Dose of Antenatal Corticosteroids SNACS Randomized Controlled Trial for Pregnancies at Risk of Preterm Delivery To Keep Babies and Children Safe
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SNACS
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 228 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 114 mg in Australia of Celestone is non-inferior to the standard double doses
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 228 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 114 mg in Australia of Celestone is non-inferior to the standard double doses
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
The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone to accelerate fetal lung maturity total 24 mg in Canada 228 mg in Australia There are no published clinical trial data on the benefits or risks of a single dose of antenatal corticosteroid vs standard double doses Ninan et al JOGC 2020
Pregnant people at 22 weeks and 0 days to 34 weeks and 6 days gestation at risk of preterm birth with a singleton or twin gestation who have received the first dose of Celestone and consented to the trial will be randomized to receive approximately 24 hours later either an experimental placebo injection of normal saline or the standard double dose of Celestone to determine whether the intervention is non-inferior for the primary outcome of a composite of perinatal mortality or substantial morbidity
Please note Based on Health Canadas guidance the study phase is Other Off-Label use However on the clincaltrialgov record Phase 4 is selected as this is the most relevant phase and there is no option to select Other
Please note McMaster University Canada is the Canadian Regulatory Sponsor and Overall Sponsor and the University of Adelaide Australia is the Australian Sponsor
The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone to accelerate fetal lung maturity total 24 mg in Canada 228 mg in Australia There are no published clinical trial data on the benefits or risks of a single dose of antenatal corticosteroid vs standard double doses Ninan et al JOGC 2020
Pregnant people at 22 weeks and 0 days to 34 weeks and 6 days gestation at risk of preterm birth with a singleton or twin gestation who have received the first dose of Celestone and consented to the trial will be randomized to receive approximately 24 hours later either an experimental placebo injection of normal saline or the standard double dose of Celestone to determine whether the intervention is non-inferior for the primary outcome of a composite of perinatal mortality or substantial morbidity
Please note Based on Health Canadas guidance the study phase is Other Off-Label use However on the clincaltrialgov record Phase 4 is selected as this is the most relevant phase and there is no option to select Other
Please note McMaster University Canada is the Canadian Regulatory Sponsor and Overall Sponsor and the University of Adelaide Australia is the Australian Sponsor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None