<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/NCT03764878</url>
  </required_header>
  <id_info>
    <org_study_id>EH18-300</org_study_id>
    <nct_id>NCT03764878</nct_id>
  </id_info>
  <brief_title>MARS: Magnetic Resonance Study: A Novel Assessment of Placental Function</brief_title>
  <official_title>MARS: Magnetic Resonance Study: A Novel Assessment of Placental Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NorthShore University HealthSystem</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NorthShore University HealthSystem</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 objective of this study is to evaluate functional MRI as a tool to study placental&#xD;
      transfer of oxygen and nutrients during the third trimester of pregnancy in obese women,&#xD;
      women with pregestational diabetes and healthy low risk women without these conditions&#xD;
      (controls). The investigators hypothesize that altered placental function, including&#xD;
      diminished placental oxygenation and enhanced placental transport of lipids and metabolites&#xD;
      will be seen in obese and pregestational diabetics as compared to controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, we propose to utilize two novel and innovative non-invasive tools to measure&#xD;
      placental oxygenation and lipid and nutrient transport in vivo in women who are obese (OB),&#xD;
      have pregestational diabetes (DM) or have neither (controls). To evaluate differences in&#xD;
      placental oxygenation, we propose to use Blood Oxygen Level Depending (BOLD) imaging, a&#xD;
      method of functional magnetic resonance imaging, to measure tissue oxygenation in the&#xD;
      placenta during the third trimester of pregnancy. To evaluate placental lipid and nutrient&#xD;
      content, we propose to utilize Magnetic Resonance Spectroscopy (MRS), a novel and powerful&#xD;
      tool to compare lipid and nutrient transport across the placenta among OB, DM and controls.&#xD;
&#xD;
      To confirm in vivo BOLD and MRS findings, we will extensively evaluate the placental lipid&#xD;
      content and lipid transport capability. Fatty acid transport protein-4 (FATP-4), one of 6&#xD;
      FATP proteins, is important for placental lipid accumulation, especially LC-PUFA21-24.&#xD;
      Docosahexaenoic acid (DHA) is a crucial LC-PUFA for neurogenesis in early development18.&#xD;
      Major facilitator super family domain containing MFSD2a is a lysophospholipid transporter&#xD;
      required for DHA uptake in the brain and has been linked to placental DHA transfer. Lipid&#xD;
      content of the placenta can be assessed by visualizing lipid droplets via perilipin 2, the&#xD;
      most abundant structural protein on the surface of lipid droplets of adipocytes.&#xD;
&#xD;
      We hypothesize that altered placental function including diminished placental oxygenation and&#xD;
      abnormal placental transport of lipids and other metabolites will be seen in OB and DM women&#xD;
      as compared to controls. We further hypothesize that ex vivo placental pathologic, histologic&#xD;
      and immunohistochemistry characteristics will be associated with in vivo findings. Our&#xD;
      findings from this pilot study have the potential to serve as the basis of a larger study to&#xD;
      further evaluate the potential impact of BOLD and MRS technology on our understanding of&#xD;
      placental lipid and oxygen transport among women with obesity and pregestational diabetes as&#xD;
      compared to women without these conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2018</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 20, 2020</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Change in BOLD response level in the placenta</measure>
    <time_frame>1 day</time_frame>
    <description>As measured by the change in MRI from baseline (room air) compared to hyperoxygenation (O2 facemask) in the central area of the placenta</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Placenta ratio of oxygenated hemoglobin to deoxygenated hemoglobin</measure>
    <time_frame>1 day</time_frame>
    <description>As measured on MRI during third trimester in the central area of the placenta</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placenta ratio of choline to lipid</measure>
    <time_frame>1 day</time_frame>
    <description>As measured on MRI during third trimester in the central area of the placenta</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Placenta Diseases</condition>
  <arm_group>
    <arm_group_label>Normal weight</arm_group_label>
    <description>BMI 18.5-24.9 kg/m^2 low risk pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pregestational diabetes mellitus</arm_group_label>
    <description>Type 1 or Type 2 diabetes mellitus diagnosed prior to the pregnancy or in the first trimester</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese</arm_group_label>
    <description>Pre-pregnancy BMI ≥ 30.0 kg/m^2</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>functional MRI</intervention_name>
    <description>Participants will undergo a functional MRI using multiple imaging modalities.</description>
    <arm_group_label>Normal weight</arm_group_label>
    <arm_group_label>Obese</arm_group_label>
    <arm_group_label>Pregestational diabetes mellitus</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Maternal and fetal cord plasma. Placental extracts. Formalin-fixed placental specimens.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women at 30-34 weeks gestation who are scheduled for a cesarean delivery. For this&#xD;
        pilot project, 10 obese (OB) women, 10 women with pregestational diabetes (PGD) and 10&#xD;
        women without OB or PGD will be recruited. OB is defined as prepregnancy or first trimester&#xD;
        BMI greater than or equal to 30 kg/ m2. PGD will be defined as Type 1 or Type 2 diabetes&#xD;
        diagnosed prior to the pregnancy or in the first trimester.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  singleton pregnancy&#xD;
&#xD;
          -  planned cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-English speaking&#xD;
&#xD;
          -  fetal anomalies&#xD;
&#xD;
          -  gestational diabetes mellitus&#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>Beth Plunkett, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>NorthShore University HealthSystem</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NorthShore University HealthSystem</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>May 17, 2023</last_update_submitted>
  <last_update_submitted_qc>May 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>NorthShore University HealthSystem</investigator_affiliation>
    <investigator_full_name>Beth Plunkett</investigator_full_name>
    <investigator_title>Clinical associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Placenta Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03764878
org study id: EH18-300
nct id: NCT03764878
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to evaluate functional MRI as a tool to study placental
      transfer of oxygen and nutrients during the third trimester of pregnancy in obese women,
      women with pregestational diabetes and healthy low risk women without these conditions
      (controls). The investigators hypothesize that altered placental function, including
      diminished placental oxygenation and enhanced placental transport of lipids and metabolites
      will be seen in obese and pregestational diabetics as compared to controls.
In this study, we propose to utilize two novel and innovative non-invasive tools to measure
      placental oxygenation and lipid and nutrient transport in vivo in women who are obese (OB),
      have pregestational diabetes (DM) or have neither (controls). To evaluate differences in
      placental oxygenation, we propose to use Blood Oxygen Level Depending (BOLD) imaging, a
      method of functional magnetic resonance imaging, to measure tissue oxygenation in the
      placenta during the third trimester of pregnancy. To evaluate placental lipid and nutrient
      content, we propose to utilize Magnetic Resonance Spectroscopy (MRS), a novel and powerful
      tool to compare lipid and nutrient transport across the placenta among OB, DM and controls.

      To confirm in vivo BOLD and MRS findings, we will extensively evaluate the placental lipid
      content and lipid transport capability. Fatty acid transport protein-4 (FATP-4), one of 6
      FATP proteins, is important for placental lipid accumulation, especially LC-PUFA21-24.
      Docosahexaenoic acid (DHA) is a crucial LC-PUFA for neurogenesis in early development18.
      Major facilitator super family domain containing MFSD2a is a lysophospholipid transporter
      required for DHA uptake in the brain and has been linked to placental DHA transfer. Lipid
      content of the placenta can be assessed by visualizing lipid droplets via perilipin 2, the
      most abundant structural protein on the surface of lipid droplets of adipocytes.

      We hypothesize that altered placental function including diminished placental oxygenation and
      abnormal placental transport of lipids and other metabolites will be seen in OB and DM women
      as compared to controls. We further hypothesize that ex vivo placental pathologic, histologic
      and immunohistochemistry characteristics will be associated with in vivo findings. Our
      findings from this pilot study have the potential to serve as the basis of a larger study to
      further evaluate the potential impact of BOLD and MRS technology on our understanding of
      placental lipid and oxygen transport among women with obesity and pregestational diabetes as
      compared to women without these conditions.
observational model: Cohort
time perspective: Prospective
measure: Change in BOLD response level in the placenta
time frame: 1 day
description: As measured by the change in MRI from baseline (room air) compared to hyperoxygenation (O2 facemask) in the central area of the placenta
measure: Placenta ratio of oxygenated hemoglobin to deoxygenated hemoglobin
time frame: 1 day
description: As measured on MRI during third trimester in the central area of the placenta
measure: Placenta ratio of choline to lipid
time frame: 1 day
description: As measured on MRI during third trimester in the central area of the placenta
arm group label: Normal weight
description: BMI 18.5-24.9 kg/m^2 low risk pregnancy
arm group label: Pregestational diabetes mellitus
description: Type 1 or Type 2 diabetes mellitus diagnosed prior to the pregnancy or in the first trimester
arm group label: Obese
description: Pre-pregnancy BMI ≥ 30.0 kg/m^2
intervention type: Diagnostic Test
intervention name: functional MRI
description: Participants will undergo a functional MRI using multiple imaging modalities.
arm group label: Normal weight
arm group label: Obese
arm group label: Pregestational diabetes mellitus
Maternal and fetal cord plasma. Placental extracts. Formalin-fixed placental specimens.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Beth Plunkett, MD, MPH
role: Principal Investigator
affiliation: NorthShore University HealthSystem
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: NorthShore University HealthSystem
investigator full name: Beth Plunkett
investigator title: Clinical associate professor
mesh term: Placenta Diseases
sharing ipd: Undecided