xml: <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/NCT05994443</url>
    </required_header>
    <id_info>
      <org_study_id>2023-8114</org_study_id>
      <nct_id>NCT05994443</nct_id>
    </id_info>
    <brief_title>Fetal Brain Growth - Pilot Study</brief_title>
    <official_title>Fetal Brain Growth: Effects of Antenatal Corticosteroids on Fetal and Neonatal Brain Development - a Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>McGill University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Arizona</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational prospective study is to explore the feasibility of measuring&#xD;
        fetal and neonatal brain growth using 2D and 3D ultrasound in fetuses exposed to threatened&#xD;
        preterm labor (TPTL) and antenatal corticosteroids (ACS) compared to non-exposed fetuses.&#xD;
  &#xD;
        Patients with singleton pregnancies on our site with repeated ultrasound measurements every 4&#xD;
        weeks will be evaluated for fetal brain development. The exposed group is defined as patients&#xD;
        with a dual exposure of TPTL and ACS. The non-exposed group will be composed of patients who&#xD;
        did not have TPTL and ACS. Therefore, patients will have a maximum of 5 additional visits (4&#xD;
        that will occur prenatally and 1 postnatal visit).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators propose a monocentric prospective pilot cohort study of patients with&#xD;
        singleton pregnancies admitted to the McGill University Health Centre (MUHC) - Royal Victoria&#xD;
        Hospital (RVH) site with repeated ultrasound measurements every 4 weeks to evaluate fetal&#xD;
        brain development. The exposed group is defined as patients with a dual exposure of TPTL and&#xD;
        ACS. The non-exposed group will be composed of patients who did not have TPTL and ACS.&#xD;
        Therefore, patients will have a maximum of 5 additional visits (4 that will occur prenatally&#xD;
        and 1 postnatal visit). The investigators plan to recruit women over a period of 24 months&#xD;
        and will need an additional period of 6 months to complete data extraction from delivery and&#xD;
        perform all postnatal measures.&#xD;
  &#xD;
        Primary Outcome: Our primary outcome will be the feasibility of a prospective observational&#xD;
        study measuring fetal and neonatal brain growth using 2D and 3D ultrasound in fetuses exposed&#xD;
        to TPTL and ACS to non-exposed fetuses. Feasibility will be defined on the following&#xD;
        criteria: 1. Number of patients recruited per month; 2. Ability to recruit eligible patients&#xD;
        and 3. Ability to successfully complete the 2D measures and 3D volumes for each ultrasound&#xD;
        exam. Success will be defined by the following criteria: 1. At least two patients will be&#xD;
        recruited per month; 2. At least 50% of all eligible patients exposed to TPTL and ACS will be&#xD;
        recruited; 3. At least 50% of all 2D measures and 3D volumes could be obtained.&#xD;
  &#xD;
        Secondary Outcomes: Our secondary outcomes will include 2D and 3D ultrasound measurements of&#xD;
        fetal brain structures, more specifically: biparietal diameter, head circumference, corpus&#xD;
        callosum length, corpus callosum-fastigium length, ventricular width, total fetal brain&#xD;
        volume, frontal lobe volume, cerebellar volume, and thalamic volume (all measurements in cm).&#xD;
        Neonatal brain structures will also be measured by 2D ultrasound, including corpus callosum&#xD;
        length and corpus callosum-fastigium length (in cm).&#xD;
  &#xD;
        Exposed patients will have a fetal ultrasound performed by a trained and qualified ultrasound&#xD;
        technologist or a Maternal-Fetal Medicine specialist within 4 days of their admission to the&#xD;
        hospital. Psychometric questionnaires will be filled on the same day. Ultrasounds will&#xD;
        subsequently be performed at fixed gestational age: 24, 28, 32, and 36 weeks (+/- 4 days).&#xD;
  &#xD;
        Non-exposed patients will have fetal ultrasound performed by a trained and qualified&#xD;
        ultrasound technologist or a Maternal-Fetal Medicine specialist at 24, 28, 32, and 36 weeks&#xD;
        (+/- 4 days). Psychometric questionnaires will be filled on each of those days.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 8, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>24 Weeks</target_duration>
    <primary_outcome>
      <measure>Feasibility - It is this a feasible project?</measure>
      <time_frame>2 years</time_frame>
      <description>Our primary outcome will be the feasibility of a prospective observational study measuring fetal and neonatal brain growth using 2D and 3D ultrasound in fetuses exposed to TPTL and ACS to non-exposed fetuses. Feasibility will be defined on the following criteria: 1. Number of patients recruited per month; 2. Ability to recruit eligible patients and 3. Ability to successfully complete the 2D measures and 3D volumes (in cm) for each ultrasound exam. Success will be defined by the following criteria: 1. At least two patients will be recruited per month; 2. At least 50% of all eligible patients exposed to TPTL and ACS will be recruited; 3. At least 50% of all 2D measures and 3D volumes could be obtained (in cm).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Prenatal ultrasound measurements</measure>
      <time_frame>2 years</time_frame>
      <description>Our secondary outcomes will include 2D and 3D ultrasound measurements (in cm) of fetal brain structures, more specifically: biparietal diameter, head circumference, corpus callosum length, corpus callosum-fastigium length, ventricular width, total fetal brain volume, frontal lobe volume, cerebellar volume, and thalamic volume (all measurements in cm). Neonatal brain structures will also be measured by 2D ultrasound, including corpus callosum length and corpus callosum-fastigium length (in cm)</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Preterm Labor</condition>
    <condition>Maternal Psychological Distress</condition>
    <arm_group>
      <arm_group_label>Pregnant women exposed to threatened preterm labor and exposed to antenatal corticosteroids</arm_group_label>
      <description>Pregnant women with threatened preterm labor (TPTL) who received antenatal corticosteroids (ACS) between 22 and 34 weeks and 6 days of gestation at our hospital.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-exposed pregnant women</arm_group_label>
      <description>Pregnant women with normal pregnancies.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with singleton pregnancies on our site.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Exposed group - TPL and ACS:&#xD;
  &#xD;
            -  22-34 weeks and 6 days gestation at time of recruitment.&#xD;
  &#xD;
            -  Threatened preterm labor (TPTL)&#xD;
  &#xD;
            -  Administration of a partial or full course of ACS.&#xD;
  &#xD;
            -  Admission to the MUHC-RVH birthing center or the antenatal floor (D6S).&#xD;
  &#xD;
            -  Delivery planned at the MUHC-RVH or an institution around the Greater Montreal Area.&#xD;
  &#xD;
          Non-exposed group:&#xD;
  &#xD;
            -  At or prior to 22 weeks gestation at time of recruitment.&#xD;
  &#xD;
            -  Delivery planned at the MUHC-RVH.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Major congenital anomalies, suspected fetal syndrome or genetic disease, or&#xD;
               intra-uterine fetal growth restriction.&#xD;
  &#xD;
            -  Significant maternal disease which may cause preterm delivery or fetal growth&#xD;
               restriction (e.g., severe infection, uncontrolled hypertension or diabetes).&#xD;
  &#xD;
            -  Patients who received more than one course of ACS prior to enrollment.&#xD;
  &#xD;
            -  Patients on any oral or other systemic corticosteroids, with the exception of inhaled&#xD;
               corticosteroids.&#xD;
  &#xD;
            -  BMI over 35.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anne-Maude Morency, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>RI-MUHC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Daniela Villegas M., MSc</last_name>
      <phone>514-412-4400</phone>
      <phone_ext>22389</phone_ext>
      <email>daniela.villegas.martinez@muhc.mcgill.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>McGill University Health Centre</name>
        <address>
          <city>Montréal</city>
          <state>Quebec</state>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniela Villegas M., MSc</last_name>
        <phone>514-412-4400</phone>
        <email>daniela.villegas.martinez@muhc.mcgill.ca</email>
      </contact>
      <investigator>
        <last_name>Anne-Maude Morency, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jarred Garfinkle, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
      <investigator_full_name>Jarred Garfinkle</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Antenatal corticosteroids</keyword>
    <keyword>fetal brain growth</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obstetric Labor, Premature</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data will be kept between collaborators.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994443
  org study id: 2023-8114
  nct id: NCT05994443
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational prospective study is to explore the feasibility of measuring
        fetal and neonatal brain growth using 2D and 3D ultrasound in fetuses exposed to threatened
        preterm labor (TPTL) and antenatal corticosteroids (ACS) compared to non-exposed fetuses.
  
        Patients with singleton pregnancies on our site with repeated ultrasound measurements every 4
        weeks will be evaluated for fetal brain development. The exposed group is defined as patients
        with a dual exposure of TPTL and ACS. The non-exposed group will be composed of patients who
        did not have TPTL and ACS. Therefore, patients will have a maximum of 5 additional visits (4
        that will occur prenatally and 1 postnatal visit).
  The investigators propose a monocentric prospective pilot cohort study of patients with
        singleton pregnancies admitted to the McGill University Health Centre (MUHC) - Royal Victoria
        Hospital (RVH) site with repeated ultrasound measurements every 4 weeks to evaluate fetal
        brain development. The exposed group is defined as patients with a dual exposure of TPTL and
        ACS. The non-exposed group will be composed of patients who did not have TPTL and ACS.
        Therefore, patients will have a maximum of 5 additional visits (4 that will occur prenatally
        and 1 postnatal visit). The investigators plan to recruit women over a period of 24 months
        and will need an additional period of 6 months to complete data extraction from delivery and
        perform all postnatal measures.
  
        Primary Outcome: Our primary outcome will be the feasibility of a prospective observational
        study measuring fetal and neonatal brain growth using 2D and 3D ultrasound in fetuses exposed
        to TPTL and ACS to non-exposed fetuses. Feasibility will be defined on the following
        criteria: 1. Number of patients recruited per month; 2. Ability to recruit eligible patients
        and 3. Ability to successfully complete the 2D measures and 3D volumes for each ultrasound
        exam. Success will be defined by the following criteria: 1. At least two patients will be
        recruited per month; 2. At least 50% of all eligible patients exposed to TPTL and ACS will be
        recruited; 3. At least 50% of all 2D measures and 3D volumes could be obtained.
  
        Secondary Outcomes: Our secondary outcomes will include 2D and 3D ultrasound measurements of
        fetal brain structures, more specifically: biparietal diameter, head circumference, corpus
        callosum length, corpus callosum-fastigium length, ventricular width, total fetal brain
        volume, frontal lobe volume, cerebellar volume, and thalamic volume (all measurements in cm).
        Neonatal brain structures will also be measured by 2D ultrasound, including corpus callosum
        length and corpus callosum-fastigium length (in cm).
  
        Exposed patients will have a fetal ultrasound performed by a trained and qualified ultrasound
        technologist or a Maternal-Fetal Medicine specialist within 4 days of their admission to the
        hospital. Psychometric questionnaires will be filled on the same day. Ultrasounds will
        subsequently be performed at fixed gestational age: 24, 28, 32, and 36 weeks (+/- 4 days).
  
        Non-exposed patients will have fetal ultrasound performed by a trained and qualified
        ultrasound technologist or a Maternal-Fetal Medicine specialist at 24, 28, 32, and 36 weeks
        (+/- 4 days). Psychometric questionnaires will be filled on each of those days.
  observational model: Cohort
  time perspective: Prospective
  measure: Feasibility - It is this a feasible project?
  time frame: 2 years
  description: Our primary outcome will be the feasibility of a prospective observational study measuring fetal and neonatal brain growth using 2D and 3D ultrasound in fetuses exposed to TPTL and ACS to non-exposed fetuses. Feasibility will be defined on the following criteria: 1. Number of patients recruited per month; 2. Ability to recruit eligible patients and 3. Ability to successfully complete the 2D measures and 3D volumes (in cm) for each ultrasound exam. Success will be defined by the following criteria: 1. At least two patients will be recruited per month; 2. At least 50% of all eligible patients exposed to TPTL and ACS will be recruited; 3. At least 50% of all 2D measures and 3D volumes could be obtained (in cm).
  measure: Prenatal ultrasound measurements
  time frame: 2 years
  description: Our secondary outcomes will include 2D and 3D ultrasound measurements (in cm) of fetal brain structures, more specifically: biparietal diameter, head circumference, corpus callosum length, corpus callosum-fastigium length, ventricular width, total fetal brain volume, frontal lobe volume, cerebellar volume, and thalamic volume (all measurements in cm). Neonatal brain structures will also be measured by 2D ultrasound, including corpus callosum length and corpus callosum-fastigium length (in cm)
  arm group label: Pregnant women exposed to threatened preterm labor and exposed to antenatal corticosteroids
  description: Pregnant women with threatened preterm labor (TPTL) who received antenatal corticosteroids (ACS) between 22 and 34 weeks and 6 days of gestation at our hospital.
  arm group label: Non-exposed pregnant women
  description: Pregnant women with normal pregnancies.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Anne-Maude Morency, MD
  role: Principal Investigator
  affiliation: RI-MUHC
  last name: Daniela Villegas M., MSc
  phone: 514-412-4400
  phone ext: 22389
  email: daniela.villegas.martinez@muhc.mcgill.ca
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
  investigator full name: Jarred Garfinkle
  investigator title: Principal Investigator
  mesh term: Obstetric Labor, Premature
  sharing ipd: No
  ipd description: Data will be kept between collaborators.