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/NCT06022458</url>
    </required_header>
    <id_info>
      <org_study_id>EH23-068</org_study_id>
      <nct_id>NCT06022458</nct_id>
    </id_info>
    <brief_title>Prenatal Sonographic Prediction of Placental Histology and Function</brief_title>
    <official_title>Prenatal Sonographic Prediction of Placental Histology and 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>Yes</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 purpose of this two-phase observational study is to investigate the use of&#xD;
        ultrasonography to predict placental pathology at the time of delivery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Placenta pathology is examined at the time of delivery and can show the underlying&#xD;
        pathophysiology of adverse pregnancy outcomes. The Amsterdam consensus has identified four&#xD;
        primary categories of injury, acute inflammation, fetal vascular malperfusion, maternal&#xD;
        vascular malperfusion, and chronic inflammation associated with adverse obstetric outcomes.&#xD;
        Findings from placental pathologic examination performed at delivery can reveal important&#xD;
        patterns of injury that lead to adverse pregnancy outcomes but cannot aid in preventing these&#xD;
        outcomes. Ultrasound of the placenta may be able to detect placental pathology in the&#xD;
        antepartum period to potentially aid in detection and treatment of placental injury. One&#xD;
        specific scenario it may be useful in is in the setting of fetal growth restriction, which&#xD;
        can be constitutional or pathologic. Identification of growth restriction in the setting of&#xD;
        placental injury may identify those patients at greatest risk for adverse outcomes.&#xD;
  &#xD;
        In the retrospective portion of this study, researchers will retrospectively evaluate&#xD;
        archived ultrasonographic images during pregnancies affected by stillbirth, severe placental&#xD;
        histology, fetal growth restriction, and milder histologic abnormalities. The goal of this&#xD;
        phase is to develop image processing of placentas and to utilize the image processing of&#xD;
        existing sonograms to correlate with the presence or absence of placental pathology at the&#xD;
        time of delivery.&#xD;
  &#xD;
        The prospective portion of this study the researchers will utilize image processing&#xD;
        techniques from the initial phase to prospectively assess placental function. The goal of&#xD;
        this phase is to evaluate if placental size, vasculature, and echogenicities among fetuses&#xD;
        with suspected growth restriction are associated with maternal vascular mal perfusion on&#xD;
        placental pathology. Twenty patients with fetal growth restriction by estimated fetal weight&#xD;
        (EFW) &lt; 10th percentile or fetal abdominal circumference (AC) &lt; 10th percentile and EFW &lt;&#xD;
        20th percentile will be recruited as the exposure group. Participants who consent will&#xD;
        complete sonographic measurements of the placenta, predefined image capture of color flow to&#xD;
        the placenta, and grayscale images every two weeks. Another twenty patients without SGA&#xD;
        (small for gestational age) or significant comorbidities will be recruited in the unexposed&#xD;
        control group. Upon consenting, these participants will complete sonographic measurements of&#xD;
        the placenta for one time. For both groups, information will be abstracted from electronic&#xD;
        medical records regarding demographic data, neonatal outcomes, and placental histology.&#xD;
        Imaging characteristics will be compared by placental histology and grade of histology at&#xD;
        delivery. As this is a pilot project, there is not an a priori power analysis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 7, 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</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>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Imaging characteristics</measure>
      <time_frame>Image characteristics will be collected every 2 weeks prenatally, and placenta will be collected at the time of delivery for analysis, this will be up to 22 weeks</time_frame>
      <description>Imaging characteristics will be compared by those with and without placental pathology found at the time of delivery</description>
    </primary_outcome>
    <enrollment type="Anticipated">320</enrollment>
    <condition>Pregnancy Complications</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Pregnant patients who plan to deliver at NorthShore University HealthSystem&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Retrospective Phase&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            -  Patients with delivery in NorthShore University HealthSystem,&#xD;
  &#xD;
            -  Ultrasound available within 4 weeks of delivery with adequate placental images&#xD;
  &#xD;
            -  Placental pathology available&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Multiple gestation&#xD;
  &#xD;
          Prospective Phase Inclusion criteria&#xD;
  &#xD;
            -  Exposed: Patients with singleton gestation with fetal growth restriction at 20-28&#xD;
               weeks with a plan to deliver at NorthShore Highland Park Hospital Evanston Hospital.&#xD;
               Patients must have a first-trimester ultrasound (&lt;14 weeks) to confirm pregnancy&#xD;
               dating available in the electronic medical record.&#xD;
  &#xD;
            -  Unexposed: Patients who present for routine ultrasound evaluation at 36-38 weeks with&#xD;
               normal fetal growth with a plan to deliver at NorthShore Highland Park Hospital or&#xD;
               NorthShore Evanston Hospital.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Exposed: Multiple gestation, major fetal anomaly&#xD;
  &#xD;
            -  Unexposed: Multiple gestation, history of chronic hypertension, gestational or&#xD;
               pregestational diabetes, major fetal anomaly antiphospholipid syndrome, known&#xD;
               thrombophilia&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Only patients of the female sex will be recruited and a large majority will identify as female.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sunitha Suresh</last_name>
      <role>Principal Investigator</role>
      <affiliation>NorthShore University HealthSystem</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sunitha Suresh</last_name>
      <phone>8475702860</phone>
      <email>SSuresh@northshore.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Olivert Mbah</last_name>
      <email>OMbah@northshore.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>NorthShore University HealthSystem</name>
        <address>
          <city>Evanston</city>
          <state>Illinois</state>
          <zip>60201</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sunitha Suresh, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>NorthShore University HealthSystem</investigator_affiliation>
      <investigator_full_name>Sunitha Suresh</investigator_full_name>
      <investigator_title>Physician, FPA</investigator_title>
    </responsible_party>
    <keyword>placenta pathology</keyword>
    <keyword>adverse pregnancy outcomes</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pregnancy Complications</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT06022458
  org study id: EH23-068
  nct id: NCT06022458
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this two-phase observational study is to investigate the use of
        ultrasonography to predict placental pathology at the time of delivery.
  Placenta pathology is examined at the time of delivery and can show the underlying
        pathophysiology of adverse pregnancy outcomes. The Amsterdam consensus has identified four
        primary categories of injury, acute inflammation, fetal vascular malperfusion, maternal
        vascular malperfusion, and chronic inflammation associated with adverse obstetric outcomes.
        Findings from placental pathologic examination performed at delivery can reveal important
        patterns of injury that lead to adverse pregnancy outcomes but cannot aid in preventing these
        outcomes. Ultrasound of the placenta may be able to detect placental pathology in the
        antepartum period to potentially aid in detection and treatment of placental injury. One
        specific scenario it may be useful in is in the setting of fetal growth restriction, which
        can be constitutional or pathologic. Identification of growth restriction in the setting of
        placental injury may identify those patients at greatest risk for adverse outcomes.
  
        In the retrospective portion of this study, researchers will retrospectively evaluate
        archived ultrasonographic images during pregnancies affected by stillbirth, severe placental
        histology, fetal growth restriction, and milder histologic abnormalities. The goal of this
        phase is to develop image processing of placentas and to utilize the image processing of
        existing sonograms to correlate with the presence or absence of placental pathology at the
        time of delivery.
  
        The prospective portion of this study the researchers will utilize image processing
        techniques from the initial phase to prospectively assess placental function. The goal of
        this phase is to evaluate if placental size, vasculature, and echogenicities among fetuses
        with suspected growth restriction are associated with maternal vascular mal perfusion on
        placental pathology. Twenty patients with fetal growth restriction by estimated fetal weight
        (EFW) < 10th percentile or fetal abdominal circumference (AC) < 10th percentile and EFW <
        20th percentile will be recruited as the exposure group. Participants who consent will
        complete sonographic measurements of the placenta, predefined image capture of color flow to
        the placenta, and grayscale images every two weeks. Another twenty patients without SGA
        (small for gestational age) or significant comorbidities will be recruited in the unexposed
        control group. Upon consenting, these participants will complete sonographic measurements of
        the placenta for one time. For both groups, information will be abstracted from electronic
        medical records regarding demographic data, neonatal outcomes, and placental histology.
        Imaging characteristics will be compared by placental histology and grade of histology at
        delivery. As this is a pilot project, there is not an a priori power analysis.
  observational model: Cohort
  time perspective: Other
  measure: Imaging characteristics
  time frame: Image characteristics will be collected every 2 weeks prenatally, and placenta will be collected at the time of delivery for analysis, this will be up to 22 weeks
  description: Imaging characteristics will be compared by those with and without placental pathology found at the time of delivery
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Only patients of the female sex will be recruited and a large majority will identify as female.
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sunitha Suresh
  role: Principal Investigator
  affiliation: NorthShore University HealthSystem
  last name: Sunitha Suresh
  phone: 8475702860
  email: SSuresh@northshore.org
  last name: Olivert Mbah
  email: OMbah@northshore.org
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: NorthShore University HealthSystem
  investigator full name: Sunitha Suresh
  investigator title: Physician, FPA
  mesh term: Pregnancy Complications
  sharing ipd: Undecided