<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04494529</url>
  </required_header>
  <id_info>
    <org_study_id>SNACS Pilot Trial</org_study_id>
    <nct_id>NCT04494529</nct_id>
  </id_info>
  <brief_title>Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth</brief_title>
  <acronym>SNACS Pilot</acronym>
  <official_title>Single Dose Antenatal Corticosteroids (SNACS) Pilot Randomized Control Trial for Women at Risk of Preterm Birth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as&#xD;
      respiratory distress syndrome, in preterm infants.&#xD;
&#xD;
      Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone&#xD;
      (for a total of 24 mg) to accelerate fetal lung maturity.&#xD;
&#xD;
      We plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing&#xD;
      half the usual dose (total 12 mg) of betamethasone to the standard double dose (total 24 mg)&#xD;
      of betamethasone.&#xD;
&#xD;
      The results of this pilot will be combined with the full-scale RCT (NCT05114096) for which we&#xD;
      have received funding from the Canadian Institutes of Health Research (CIHR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preterm infants are at risk of mortality and morbidity. Antenatal corticosteroids (ACS)&#xD;
      reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome.&#xD;
&#xD;
      Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone&#xD;
      (for a total of 24 mg) to accelerate fetal lung maturity. There are no published clinical&#xD;
      trial data on the benefits or risks of a single dose of antenatal corticosteroid vs. standard&#xD;
      double doses.&#xD;
&#xD;
      Pilot trials are now viewed as an &quot;almost essential prerequisite&quot; to large, expensive, full&#xD;
      scale studies. Thus, we plan to conduct a pilot clinical trial to determine the feasibility&#xD;
      of a trial comparing half the usual dose (12 mg of betamethasone + placebo) to the standard&#xD;
      double dose (12 mg + 12 mg of betamethasone), as well as the feasibility of the study&#xD;
      protocol. Secondary outcomes will include process outcomes and pilot clinical outcomes, that&#xD;
      will be combined with the full-scale RCT for which we have received funding from CIHR.&#xD;
&#xD;
      We plan to conduct a 24-month corrected gestational age follow-up, which will consist&#xD;
      principally of 2 validated parent-filled questionnaires:&#xD;
&#xD;
        1. Ages and Stages Questionnaire-3 (ASQ)&#xD;
&#xD;
        2. Child Behavior Checklist&#xD;
&#xD;
        3. A single question parent report of whether there has been a physician diagnosis of&#xD;
           cerebral palsy. (recommended by our parent partners)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2021</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Pilot double-blind randomized controlled trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of conducting a full-scale trial</measure>
    <time_frame>5-6 months</time_frame>
    <description>Feasibility of conducting a full-scale trial will be defined as =&gt; 50% recruitment of approached participants</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of the study protocol</measure>
    <time_frame>5-6 months</time_frame>
    <description>Feasibility of the study intervention will be defined as =&gt; 98% compliance with the protocol</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Process outcomes</measure>
    <time_frame>5-6 months</time_frame>
    <description>The proportions of patients who: will be approached by the circle of care, and will agree to be approached by the research team, and will agree to participate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal mortality rates</measure>
    <time_frame>5-6 months</time_frame>
    <description>Pilot clinical data on neonatal mortality, from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory morbidity rates</measure>
    <time_frame>5-6 months</time_frame>
    <description>Pilot clinical data on respiratory morbidity, from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe intraventricular haemorrhage rates</measure>
    <time_frame>5-6 months</time_frame>
    <description>Pilot clinical data on severe intraventricular haemorrhage, from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of severe bowel problems due to necrotizing enterocolitis</measure>
    <time_frame>5-6 months</time_frame>
    <description>Pilot clinical data on severe bowel problems due to necrotizing enterocolitis, from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation requiring an endotracheal tube</measure>
    <time_frame>5-6 months</time_frame>
    <description>Pilot clinical data on duration of mechanical ventilation requiring an endotracheal tube, from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for supplemental oxygen and duration</measure>
    <time_frame>5-6 months</time_frame>
    <description>Pilot clinical data on need for supplemental oxygen and duration, from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late respiratory morbidity (i.e. bronchopulmonary dysplasia) rates</measure>
    <time_frame>5-6 months</time_frame>
    <description>Pilot clinical data on late respiratory morbidity (i.e. bronchopulmonary dysplasia), from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early neonatal sepsis rates</measure>
    <time_frame>5-6 months</time_frame>
    <description>Pilot clinical data on early neonatal sepsis, from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe late brain injury (periventricular leukomalacia) rates</measure>
    <time_frame>5-6 months</time_frame>
    <description>Pilot clinical data on severe late brain injury (periventricular leukomalacia), from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intrauterine fetal demise rates</measure>
    <time_frame>5-6 months</time_frame>
    <description>Pilot clinical data on intrauterine fetal demise, from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of ventilatory support not requiring an endotracheal tube</measure>
    <time_frame>5-6 months</time_frame>
    <description>Pilot clinical data on duration of ventilatory support not requiring an endotracheal tube, from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of hypotension &lt; 48 hours of life requiring treatment with hydrocortisone or inotropic medications</measure>
    <time_frame>5-6 months</time_frame>
    <description>Pilot clinical data on hypotension &lt; 48 hours of life requiring treatment with hydrocortisone or inotropic medications, from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in neonatal intensive care unit</measure>
    <time_frame>5-6 months</time_frame>
    <description>Pilot clinical data on length of stay in neonatal intensive care unit, from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometry composite (&lt;10% of expected weight, length, or head circumference for birth week)</measure>
    <time_frame>5-6 months</time_frame>
    <description>Pilot clinical data on anthropometry (&lt;10% of expected weight, length, or head circumference for birth week), from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of infants with retinopathy of prematurity needing treatment</measure>
    <time_frame>5-6 months</time_frame>
    <description>Pilot clinical data on retinopathy of prematurity needing treatment, from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patent ductus arteriosus needing a closure procedure</measure>
    <time_frame>5-6 months</time_frame>
    <description>Pilot clinical data on number of infants with patent ductus arteriosus needing a closure procedure, from medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24-month follow-up</measure>
    <time_frame>18-30 months</time_frame>
    <description>Neurosensory/developmental progress at 24 months corrected gestational age, which will consist principally of 2 validated parent-filled questionnaires:&#xD;
Ages and Stages Questionnaire-3 (ASQ)&#xD;
Child Behavior Checklist&#xD;
A single-question parent report of whether there has been a physician diagnosis of cerebral palsy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Preterm Birth</condition>
  <condition>Complication of Prematurity</condition>
  <condition>Obstetric Labor, Premature</condition>
  <condition>Obstetric Labor Complications</condition>
  <condition>Pregnancy Complications</condition>
  <arm_group>
    <arm_group_label>Single-Dose (12 mg betamethasone + placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.&#xD;
Participants randomized to the experimental &quot;Single-Dose&quot; 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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Double-Dose (12 mg betamethasone + 12 mg betamethasone)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.&#xD;
Participants randomized to the &quot;Double-Dose&quot; 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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>12 mg betamethasone + placebo</intervention_name>
    <description>After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the &quot;Placebo Comparator&quot; group will receive 1 intramuscular injection of placebo.</description>
    <arm_group_label>Single-Dose (12 mg betamethasone + placebo)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>24 mg betamethasone</intervention_name>
    <description>After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the &quot;Active Comparator&quot; group will receive the standard 2nd intramuscular injection of 12 mg of betamethasone.</description>
    <arm_group_label>Double-Dose (12 mg betamethasone + 12 mg betamethasone)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pregnant women at risk of preterm birth with a singleton or twins between =&gt;22+0/7 and&#xD;
             &lt;=34+6/7 weeks' gestation&#xD;
&#xD;
          2. Pregnant with either singletons or twins&#xD;
&#xD;
          3. Has already received the first dose of 12 mg intramuscular betamethasone within the&#xD;
             past 24 hours&#xD;
&#xD;
          4. All fetuses are alive and without compromise as per ultrasound or fetal heart monitor&#xD;
&#xD;
          5. Is capable of giving informed, written consent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any contraindications to receiving corticosteroids&#xD;
&#xD;
          2. Requires chronic doses of corticosteroids secondary to a medical condition (e.g.&#xD;
             systemic lupus erythematosus, severe asthma, congenital adrenal hyperplasia, etc.)&#xD;
&#xD;
          3. Received any prior doses of antenatal corticosteroids except for the 1st dose of 12 mg&#xD;
             intramuscular betamethasone&#xD;
&#xD;
          4. Had any previous participation in this trial&#xD;
&#xD;
          5. Pregnant with a fetus with severe congenital anomaly (e.g. anencephaly, transposition&#xD;
             of the great arteries, etc.) or major chromosomal abnormalities (e.g. Trisomy 18,&#xD;
             Trisomy 21, etc.)&#xD;
&#xD;
          6. Pregnant with monoamniotic/monochorionic (Mono/Mono) twins&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah D McDonald, MD, MSc, FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kellie Murphy, MD, MSc, FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McMaster University Medical Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>August 21, 2023</last_update_submitted>
  <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Sarah McDonald</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Premature birth</keyword>
  <keyword>Preterm birth</keyword>
  <keyword>Obstetric labor</keyword>
  <keyword>Betamethasone Valerate</keyword>
  <keyword>Betamethasone-17,21-dipropionate</keyword>
  <keyword>Betamethasone benzoate; Betamethasone sodium phosphate</keyword>
  <keyword>Anti-Inflammatory Agents</keyword>
  <keyword>Glucocorticoids</keyword>
  <keyword>Hormones</keyword>
  <keyword>Hormone Substitutes</keyword>
  <keyword>Hormone Antagonists</keyword>
  <keyword>Physiological Effect of Drugs</keyword>
  <keyword>Anti-Asthmatic Agents</keyword>
  <keyword>Respiratory System Agents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Obstetric Labor Complications</mesh_term>
    <mesh_term>Obstetric Labor, Premature</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Betamethasone</mesh_term>
    <mesh_term>Betamethasone Valerate</mesh_term>
    <mesh_term>Betamethasone-17,21-dipropionate</mesh_term>
    <mesh_term>Betamethasone benzoate</mesh_term>
    <mesh_term>Betamethasone sodium phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04494529
org study id: SNACS Pilot Trial
nct id: NCT04494529
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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).
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)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pilot double-blind randomized controlled trial
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Feasibility of conducting a full-scale trial
time frame: 5-6 months
description: Feasibility of conducting a full-scale trial will be defined as => 50% recruitment of approached participants
measure: Feasibility of the study protocol
time frame: 5-6 months
description: Feasibility of the study intervention will be defined as => 98% compliance with the protocol
measure: Process outcomes
time frame: 5-6 months
description: The proportions of patients who: will be approached by the circle of care, and will agree to be approached by the research team, and will agree to participate
measure: Neonatal mortality rates
time frame: 5-6 months
description: Pilot clinical data on neonatal mortality, from medical records
measure: Respiratory morbidity rates
time frame: 5-6 months
description: Pilot clinical data on respiratory morbidity, from medical records
measure: Severe intraventricular haemorrhage rates
time frame: 5-6 months
description: Pilot clinical data on severe intraventricular haemorrhage, from medical records
measure: Rates of severe bowel problems due to necrotizing enterocolitis
time frame: 5-6 months
description: Pilot clinical data on severe bowel problems due to necrotizing enterocolitis, from medical records
measure: Duration of mechanical ventilation requiring an endotracheal tube
time frame: 5-6 months
description: Pilot clinical data on duration of mechanical ventilation requiring an endotracheal tube, from medical records
measure: Need for supplemental oxygen and duration
time frame: 5-6 months
description: Pilot clinical data on need for supplemental oxygen and duration, from medical records
measure: Late respiratory morbidity (i.e. bronchopulmonary dysplasia) rates
time frame: 5-6 months
description: Pilot clinical data on late respiratory morbidity (i.e. bronchopulmonary dysplasia), from medical records
measure: Early neonatal sepsis rates
time frame: 5-6 months
description: Pilot clinical data on early neonatal sepsis, from medical records
measure: Severe late brain injury (periventricular leukomalacia) rates
time frame: 5-6 months
description: Pilot clinical data on severe late brain injury (periventricular leukomalacia), from medical records
measure: Intrauterine fetal demise rates
time frame: 5-6 months
description: Pilot clinical data on intrauterine fetal demise, from medical records
measure: Duration of ventilatory support not requiring an endotracheal tube
time frame: 5-6 months
description: Pilot clinical data on duration of ventilatory support not requiring an endotracheal tube, from medical records
measure: Rates of hypotension < 48 hours of life requiring treatment with hydrocortisone or inotropic medications
time frame: 5-6 months
description: Pilot clinical data on hypotension < 48 hours of life requiring treatment with hydrocortisone or inotropic medications, from medical records
measure: Length of stay in neonatal intensive care unit
time frame: 5-6 months
description: Pilot clinical data on length of stay in neonatal intensive care unit, from medical records
measure: Anthropometry composite (<10% of expected weight, length, or head circumference for birth week)
time frame: 5-6 months
description: Pilot clinical data on anthropometry (<10% of expected weight, length, or head circumference for birth week), from medical records
measure: Number of infants with retinopathy of prematurity needing treatment
time frame: 5-6 months
description: Pilot clinical data on retinopathy of prematurity needing treatment, from medical records
measure: Patent ductus arteriosus needing a closure procedure
time frame: 5-6 months
description: Pilot clinical data on number of infants with patent ductus arteriosus needing a closure procedure, from medical records
measure: 24-month follow-up
time frame: 18-30 months
description: Neurosensory/developmental progress at 24 months corrected gestational age, which will consist principally of 2 validated parent-filled questionnaires:
Ages and Stages Questionnaire-3 (ASQ)
Child Behavior Checklist
A single-question parent report of whether there has been a physician diagnosis of cerebral palsy.
arm group label: Single-Dose (12 mg betamethasone + placebo)
arm group type: Placebo Comparator
description: 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).
arm group label: Double-Dose (12 mg betamethasone + 12 mg betamethasone)
arm group type: Active Comparator
description: 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).
intervention type: Drug
intervention name: 12 mg betamethasone + placebo
description: After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.
arm group label: Single-Dose (12 mg betamethasone + placebo)
intervention type: Drug
intervention name: 24 mg betamethasone
description: 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.
arm group label: Double-Dose (12 mg betamethasone + 12 mg betamethasone)
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 55 Years
healthy volunteers: No
last name: Sarah D McDonald, MD, MSc, FRCSC
role: Principal Investigator
affiliation: McMaster University
last name: Kellie Murphy, MD, MSc, FRCSC
role: Principal Investigator
affiliation: University of Toronto
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Sarah McDonald
investigator title: Principal Investigator
mesh term: Premature Birth
mesh term: Pregnancy Complications
mesh term: Obstetric Labor Complications
mesh term: Obstetric Labor, Premature
mesh term: Betamethasone
mesh term: Betamethasone Valerate
mesh term: Betamethasone-17,21-dipropionate
mesh term: Betamethasone benzoate
mesh term: Betamethasone sodium phosphate
sharing ipd: No