Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth (SNACS Pilot)
Preterm Birth, Complication of Prematurity, Obstetric Labor, Premature
About this trial
This is an interventional other trial for Preterm Birth focused on measuring Premature birth, Preterm birth, Obstetric labor, Betamethasone Valerate, Betamethasone-17,21-dipropionate, Betamethasone benzoate; Betamethasone sodium phosphate, Anti-Inflammatory Agents, Glucocorticoids, Hormones, Hormone Substitutes, Hormone Antagonists, Physiological Effect of Drugs, Anti-Asthmatic Agents, Respiratory System Agents
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- McMaster University Medical Centre
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Single-Dose (12 mg betamethasone + placebo)
Double-Dose (12 mg betamethasone + 12 mg betamethasone)
The standard course of betamethasone consists of 2 intramuscular injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg. Before enrolment and randomization in the SNACS trial, all women will have received a first 12 mg injection of betamethasone according to local hospital protocols. After this first injection, randomization is performed. Participants randomized to the experimental "Single-Dose" arm will receive a similar appearing placebo injection instead of the standard 2nd dose of 12 mg of betamethasone (i.e. they will receive the experimental single-dose regimen, total 12 mg of betamethasone only from the first injection).
The standard course of betamethasone consists of 2 intramuscular injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg. Before enrolment and randomization in the SNACS trial, all women will have received a first 12 mg injection of betamethasone according to local hospital protocols. After this first injection, randomization is performed. Participants randomized to the "Double-Dose" arm will receive the standard 2nd dose of 12 mg of betamethasone injected intramuscularly (i.e. they will receive the standard double-dose regimen, total 24 mg of betamethasone).