<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/NCT03782168</url>
  </required_header>
  <id_info>
    <org_study_id>228485</org_study_id>
    <nct_id>NCT03782168</nct_id>
  </id_info>
  <brief_title>Plasma Concentration of Biological Markers in Placental Abruption</brief_title>
  <official_title>Plasma Concentration of Biological Markers in Placental Abruption</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arkansas</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>
      This will be a prospective study conducted on women with a suspected/confirmed diagnosis of&#xD;
      placental abruption. Maternal blood samples will be taken at various points during the&#xD;
      peripartum period. A healthy group of women admitted for delivery will act as a matched&#xD;
      control and will have their blood sampled at similar time points. The primary outcome&#xD;
      variables will include the total number of micro-particles, the number of micro-particles&#xD;
      from each cell line (platelet, placental, endothelial etc.), and protein markers&#xD;
      (specifically; placental growth factor (PlGF), soluble fms-like tyrosine kinase-1 (sFLT-1),&#xD;
      vascular endothelial growth factor (VEGF), soluble endoglin (sEng)). Secondary outcomes if&#xD;
      will examine the correlation between placental micro-particles, biomarkers, and extent of&#xD;
      placental abruption.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine how well maternal serum biomarkers and placental&#xD;
      micro-particles (MP) correlate with PA. The sensitivity and specificity of these proteins&#xD;
      will be analyzed to further increase our understanding of the pathological mechanisms&#xD;
      involved in PA. The knowledge gained from this study has the potential to develop a&#xD;
      diagnostic test for PA with the ability to improve outcomes for mother and baby through&#xD;
      earlier diagnosis and targeted therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    IRB approval expired; failure to submit continuing review in time. Will re-open once IRB&#xD;
    approval is reinstated.&#xD;
  </why_stopped>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">August 1, 2021</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Determine the level of placental-derived MPs (Microparticles/mL)</measure>
    <time_frame>Up to 75 minutes</time_frame>
    <description>Determine quantitatively the level of placental-derived MPs which may be altered in 10 subjects with PA compared to 10 matched control subjects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identify biomarkers (picogram/mL) specifically, placental growth factor (PlGF), vascular endothelial growth factor (VEGF), soluble fms-like tyrosine kinase-1 (sFLT-1), and soluble endoglin (sEng)</measure>
    <time_frame>Up to 75 minutes</time_frame>
    <description>Determine quantitatively the level of biomarkers which may be altered in 10 subjects with PA compared to 10 matched control subjects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Examine the correlation between maternal serum total placental MPs and biomarkers to clinical symptomology and the severity of placental abruption after delivery.</measure>
    <time_frame>Up to 75 minutes</time_frame>
    <description>In order to evaluate the secondary outcome, the correlation between maternal serum total placental MPs, biomarkers to clinical symptomology, and the severity of placental abruption after delivery will be examined.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1</enrollment>
  <condition>Abruptio Placentae</condition>
  <arm_group>
    <arm_group_label>Placental Abruption</arm_group_label>
    <description>Mother-infant dyads with suspected or confirmed diagnosis of placental abruption</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phenotypically-matched controlled group</arm_group_label>
    <description>Healthy mother-infant dyads admitted for delivery</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood for serum biomarkers and placental micro-particles.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Mother-infant dyads with suspected or confirmed diagnosis of placental abruption and&#xD;
        healthy mother-infant dyads admitted for delivery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 - to 45-years old, inclusive&#xD;
&#xD;
          -  Suspected or confirmed PA or phenotypically matched controls&#xD;
&#xD;
          -  All modes of delivery&#xD;
&#xD;
          -  Gestational age greater than 28 weeks&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intrauterine fetal demise,&#xD;
&#xD;
          -  Severe fetal anomalies (infant not expected to survive)&#xD;
&#xD;
          -  Inability to communicate in English&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadir Shawrawi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arkansas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>November 17, 2021</last_update_submitted>
  <last_update_submitted_qc>November 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abruptio Placentae</mesh_term>
  </condition_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/NCT03782168
org study id: 228485
nct id: NCT03782168
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This will be a prospective study conducted on women with a suspected/confirmed diagnosis of
      placental abruption. Maternal blood samples will be taken at various points during the
      peripartum period. A healthy group of women admitted for delivery will act as a matched
      control and will have their blood sampled at similar time points. The primary outcome
      variables will include the total number of micro-particles, the number of micro-particles
      from each cell line (platelet, placental, endothelial etc.), and protein markers
      (specifically; placental growth factor (PlGF), soluble fms-like tyrosine kinase-1 (sFLT-1),
      vascular endothelial growth factor (VEGF), soluble endoglin (sEng)). Secondary outcomes if
      will examine the correlation between placental micro-particles, biomarkers, and extent of
      placental abruption.
The purpose of this study is to determine how well maternal serum biomarkers and placental
      micro-particles (MP) correlate with PA. The sensitivity and specificity of these proteins
      will be analyzed to further increase our understanding of the pathological mechanisms
      involved in PA. The knowledge gained from this study has the potential to develop a
      diagnostic test for PA with the ability to improve outcomes for mother and baby through
      earlier diagnosis and targeted therapy.
observational model: Case-Control
time perspective: Prospective
measure: Determine the level of placental-derived MPs (Microparticles/mL)
time frame: Up to 75 minutes
description: Determine quantitatively the level of placental-derived MPs which may be altered in 10 subjects with PA compared to 10 matched control subjects.
measure: Identify biomarkers (picogram/mL) specifically, placental growth factor (PlGF), vascular endothelial growth factor (VEGF), soluble fms-like tyrosine kinase-1 (sFLT-1), and soluble endoglin (sEng)
time frame: Up to 75 minutes
description: Determine quantitatively the level of biomarkers which may be altered in 10 subjects with PA compared to 10 matched control subjects.
measure: Examine the correlation between maternal serum total placental MPs and biomarkers to clinical symptomology and the severity of placental abruption after delivery.
time frame: Up to 75 minutes
description: In order to evaluate the secondary outcome, the correlation between maternal serum total placental MPs, biomarkers to clinical symptomology, and the severity of placental abruption after delivery will be examined.
arm group label: Placental Abruption
description: Mother-infant dyads with suspected or confirmed diagnosis of placental abruption
arm group label: Phenotypically-matched controlled group
description: Healthy mother-infant dyads admitted for delivery
Whole blood for serum biomarkers and placental micro-particles.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Nadir Shawrawi, MD
role: Principal Investigator
affiliation: University of Arkansas
facility: 
country: United States
responsible party type: Sponsor
mesh term: Abruptio Placentae
sharing ipd: No