<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/NCT03801447</url>
  </required_header>
  <id_info>
    <org_study_id>DAC-003-REPORTS</org_study_id>
    <nct_id>NCT03801447</nct_id>
  </id_info>
  <brief_title>Biomarkers and Preeclampsia Outcomes</brief_title>
  <acronym>REPORTS</acronym>
  <official_title>Ratio of Angiogenesis-related Biomarkers (sFlt-1/PlGF) in the Prediction Of mateRnal &amp; feTal outcomeS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dacima Consulting</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maternity Center of Tunis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dacima Consulting</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>
      Prospective, observational, monocentric, non-interventional study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In practice, patients with preeclampsia are referred to the hospital for medical management&#xD;
      only clinical signs &amp; symptoms and standard biological tests are available for patient&#xD;
      individualized care. Hence, a new diagnostic tool to distinguish and stratify the different&#xD;
      patients referred is in need of proper triage.&#xD;
&#xD;
      REPORTS study aims to determine the diagnostic utility of 2 preeclampsia biomarkers&#xD;
      (sFlt-1/PlGF ratio) in clinical decision making in preeclamptic women.&#xD;
&#xD;
      Data are collected by DACIMA Clinical Suite, according to FDA 21 CFR part 11 requirements&#xD;
      (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA&#xD;
      specifications (Health Insurance Portability and Accountability Act), and the ICH standards&#xD;
      (International Conference on Harmonisation)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</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>Biomarkers ratio</measure>
    <time_frame>Every day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with severe preeclampsia</time_frame>
    <description>sFlt-1/PlGF ratio</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomarkers ratio</measure>
    <time_frame>Every two day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with moderate preeclampsia</time_frame>
    <description>sFlt-1/PlGF ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers ratio</measure>
    <time_frame>Weekly from date of inclusion until date of delivery or up to 3 weeks whichever came first, in women with mild preeclampsia</time_frame>
    <description>sFlt-1/PlGF ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal outcome</measure>
    <time_frame>From date of inclusion until the date of first documented event, assessed up to 24 weeks</time_frame>
    <description>Incidence of retroplacental hematoma, or HELLP syndrome (Hemolysis, Elevated liver enzyme levels, and Low Platelet levels), or Renal failure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal outcome</measure>
    <time_frame>From date of inclusion until the date of first documented event, assessed up to 24 weeks</time_frame>
    <description>Incidence of a composite fetal outcome (in utero fetal death or, Intrauterine growth restriction, or APGAR &lt; 7, or Prematurity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal outcome</measure>
    <time_frame>Date of delivery</time_frame>
    <description>Rate of in utero fetal death or, Intrauterine growth restriction, or APGAR &lt; 7, or Prematurity</description>
  </secondary_outcome>
  <enrollment type="Actual">600</enrollment>
  <condition>Preeclampsia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Preeclampsia was defined according to the ACOG (The American College of Obstetricians and&#xD;
        Gynecologists). The diagnosis of Preeclampsia was based on clinical judgment and routine&#xD;
        laboratory findings at inclusion.&#xD;
&#xD;
        Patients were suspected of Preeclampsia if they:&#xD;
&#xD;
          -  presented with new onset hypertension and or proteinuria at or after 20 weeks of&#xD;
             gestation&#xD;
&#xD;
          -  developed an aggravation of their preexisting hypertension and or preexisting&#xD;
             proteinuria&#xD;
&#xD;
          -  or if they presented with symptoms such as right upper quadrant abdominal pain or&#xD;
             headache with visual disturbances or PE-related findings (low platelets, elevated&#xD;
             liver transaminases, Vascular Fetal Growth Restriction)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspected or confirmed preeclampsia&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Between 26 weeks of gestation and 37 weeks of gestation &amp; 6 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple pregnancies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dalenda Chelli, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Maternité de la Rabta - Tunis</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Youcef Djedid, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maternité de la Rabta - Tunis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maternity Center of Tunis</name>
      <address>
        <city>Tunis</city>
        <zip>1006</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>August 19, 2022</last_update_submitted>
  <last_update_submitted_qc>August 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2022</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>Pre-Eclampsia</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/NCT03801447
org study id: DAC-003-REPORTS
nct id: NCT03801447
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective, observational, monocentric, non-interventional study.
In practice, patients with preeclampsia are referred to the hospital for medical management
      only clinical signs & symptoms and standard biological tests are available for patient
      individualized care. Hence, a new diagnostic tool to distinguish and stratify the different
      patients referred is in need of proper triage.

      REPORTS study aims to determine the diagnostic utility of 2 preeclampsia biomarkers
      (sFlt-1/PlGF ratio) in clinical decision making in preeclamptic women.

      Data are collected by DACIMA Clinical Suite, according to FDA 21 CFR part 11 requirements
      (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA
      specifications (Health Insurance Portability and Accountability Act), and the ICH standards
      (International Conference on Harmonisation)
observational model: Cohort
time perspective: Prospective
measure: Biomarkers ratio
time frame: Every day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with severe preeclampsia
description: sFlt-1/PlGF ratio
measure: Biomarkers ratio
time frame: Every two day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with moderate preeclampsia
description: sFlt-1/PlGF ratio
measure: Biomarkers ratio
time frame: Weekly from date of inclusion until date of delivery or up to 3 weeks whichever came first, in women with mild preeclampsia
description: sFlt-1/PlGF ratio
measure: Maternal outcome
time frame: From date of inclusion until the date of first documented event, assessed up to 24 weeks
description: Incidence of retroplacental hematoma, or HELLP syndrome (Hemolysis, Elevated liver enzyme levels, and Low Platelet levels), or Renal failure.
measure: Fetal outcome
time frame: From date of inclusion until the date of first documented event, assessed up to 24 weeks
description: Incidence of a composite fetal outcome (in utero fetal death or, Intrauterine growth restriction, or APGAR < 7, or Prematurity)
measure: Fetal outcome
time frame: Date of delivery
description: Rate of in utero fetal death or, Intrauterine growth restriction, or APGAR < 7, or Prematurity
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
last name: Dalenda Chelli, MD
role: Study Chair
affiliation: Maternité de la Rabta - Tunis
last name: Youcef Djedid, MD
role: Principal Investigator
affiliation: Maternité de la Rabta - Tunis
facility: 
country: Tunisia
responsible party type: Sponsor
mesh term: Pre-Eclampsia
sharing ipd: No