Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth

• Status: Recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: Female

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 includes 2 doses of 12 mg betamethasone (for a total of 24 mg) to accelerate fetal lung maturity.

We plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose (total 12 mg) of betamethasone to the standard double dose (total 24 mg) of betamethasone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate

Criteria

Inclusion Criteria:

1. Pregnant women at risk of preterm birth with a singleton or twins between =>22+0/7 and <=34+6/7 weeks' gestation

2. Pregnant with either singletons or twins

3. Has already received the first dose of 12 mg intramuscular betamethasone within the past 24 hours

4. All fetuses are alive and without compromise as per ultrasound or fetal heart monitor

5. Is capable of giving informed, written consent in English

Exclusion Criteria:

1. Any contraindications to receiving corticosteroids

2. Requires chronic doses of corticosteroids secondary to a medical condition (e.g. systemic lupus erythematosus, severe asthma, congenital adrenal hyperplasia, etc.)

3. Received any prior doses of antenatal corticosteroids except for the 1st dose of 12 mg intramuscular betamethasone

4. Had any previous participation in this trial

5. 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.)

6. Pregnant with monoamniotic/monochorionic (Mono/Mono) twins