Status:
COMPLETED
Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth
Lead Sponsor:
McMaster University
Conditions:
Preterm Birth
Complication of Prematurity
Eligibility:
FEMALE
16-55 years
Phase:
PHASE3
Brief 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 incl...
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. Standard of care for...
Eligibility Criteria
Inclusion
- Pregnant women at risk of preterm birth with a singleton or twins between =\>22+0/7 and \<=34+6/7 weeks' gestation
- Pregnant with either singletons or twins
- Has already received the first dose of 12 mg intramuscular betamethasone within the past 24 hours
- All fetuses are alive and without compromise as per ultrasound or fetal heart monitor
- Is capable of giving informed, written consent in English
Exclusion
- Any contraindications to receiving corticosteroids
- Requires chronic doses of corticosteroids secondary to a medical condition (e.g. systemic lupus erythematosus, severe asthma, congenital adrenal hyperplasia, etc.)
- Received any prior doses of antenatal corticosteroids except for the 1st dose of 12 mg intramuscular betamethasone
- Had any previous participation in this trial
- Pregnant with a fetus with severe congenital anomaly (e.g. anencephaly, transposition of the great arteries, etc.) or major chromosomal abnormalities (e.g. Trisomy 18, Trisomy 21, etc.)
- Pregnant with monoamniotic/monochorionic (Mono/Mono) twins
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04494529
Start Date
March 1 2021
End Date
August 31 2021
Last Update
August 23 2023
Active Locations (1)
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1
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N3Z5