Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth
Condition: Preterm Birth; Complication of Prematurity; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications
MeSH terms: Premature Birth; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 3

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.

      The results of this pilot will be combined with the full-scale RCT (NCT05114096) for which we
      have received funding from the Canadian Institutes of Health Research (CIHR).
    

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 women at risk of preterm birth includes 2 doses of 12 mg betamethasone
      (for a total of 24 mg) to accelerate fetal lung maturity. There are no published clinical
      trial data on the benefits or risks of a single dose of antenatal corticosteroid vs. standard
      double doses.

      Pilot trials are now viewed as an "almost essential prerequisite" to large, expensive, full
      scale studies. Thus, we plan to conduct a pilot clinical trial to determine the feasibility
      of a trial comparing half the usual dose (12 mg of betamethasone + placebo) to the standard
      double dose (12 mg + 12 mg of betamethasone), as well as the feasibility of the study
      protocol. Secondary outcomes will include process outcomes and pilot clinical outcomes, that
      will be combined with the full-scale RCT for which we have received funding from CIHR.

      We plan to conduct a 24-month corrected gestational age follow-up, which will consist
      principally of 2 validated parent-filled questionnaires:

        1. Ages and Stages Questionnaire-3 (ASQ)

        2. Child Behavior Checklist

        3. A single question parent report of whether there has been a physician diagnosis of
           cerebral palsy. (recommended by our parent partners)
    

Intervention name(s): 12 mg betamethasone + placebo; 24 mg betamethasone
Intervention type(s): Drug; Drug
Intervention description(s): After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.; After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Active Comparator" group will receive the standard 2nd intramuscular injection of 12 mg of betamethasone.
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot double-blind randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: 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