<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/NCT03767803</url>
  </required_header>
  <id_info>
    <org_study_id>PRO-129-PREECLAMPSIA</org_study_id>
    <nct_id>NCT03767803</nct_id>
  </id_info>
  <brief_title>Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women</brief_title>
  <official_title>Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Progenity, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Progenity, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Whole blood sample procurement study from pregnant women with signs and symptoms of&#xD;
      Preeclampsia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multicenter non-interventional observational sample acquisition study is designed to&#xD;
      acquire whole-blood samples from pregnant women who present with signs and symptoms of Pre-E&#xD;
      and are in the care at an OB-GYN and/or Maternal Fetal Medicine (MFM) site, defined as&#xD;
      outpatient centers, clinic sites, and medical offices.&#xD;
&#xD;
      Study population includes subjects who are pregnant, of any race or ethnicity, 18 to 45 years&#xD;
      of age, 28 0/7 to 36 6/7 weeks' gestational age with a singleton fetus and have provided&#xD;
      written informed consent to provide whole blood specimens at one or more study visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Diagnosis of preeclampsia is determined by standard of care.</measure>
    <time_frame>3 months</time_frame>
    <description>Observational, non-interventional sample procurement study in which participants are treated per standard of care</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">344</enrollment>
  <condition>Pre-Eclampsia</condition>
  <condition>Hypertension</condition>
  <condition>Proteinuria in Pregnancy</condition>
  <condition>Thrombocytopenia</condition>
  <condition>Renal Insufficiency</condition>
  <condition>Impaired Liver Function</condition>
  <condition>Pulmonary Edema</condition>
  <condition>Headache</condition>
  <condition>Visual Impairment</condition>
  <arm_group>
    <arm_group_label>Positive Preeclampsia group</arm_group_label>
    <description>A group with diagnosis of preeclampsia within 24 hours of testing and pre-term delivery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Cohort</arm_group_label>
    <description>A group without diagnosis of preeclampsia. Also includes a group without diagnosis of preeclampsia within 24 hours of testing, but who have subsequent worsening or re-emergence of signs and symptoms of preeclampsia, and are later diagnosed with preeclampsia and have pre-term delivery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-interventional study</intervention_name>
    <description>This is an observational, non-interventional study.</description>
    <arm_group_label>Positive Preeclampsia group</arm_group_label>
    <arm_group_label>Study Cohort</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      This study will collect 20 mL whole blood samples from subjects at one or more study visits.&#xD;
      The whole blood will be processed to plasma and stored for testing.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who are pregnant, of any race or ethnicity, 18 to 45 years of age, 28 0/7 to 36&#xD;
        6/7 weeks' gestational age with a singleton fetus and have provided written informed&#xD;
        consent to provide whole blood specimens at one or more study visits.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is 18 to 45 years of age&#xD;
&#xD;
          -  Subject is willing to provide informed consent&#xD;
&#xD;
          -  Subject enrolling at a study OB-GYN or MFM site is in the opinion of the physician&#xD;
             able to provide 20 mL of whole blood and will comply with all study procedures&#xD;
&#xD;
          -  Subject has a singleton fetus of 28 0/7 to 36 6/7 weeks' gestational age using 2014&#xD;
             ACOG Dating Criteria (pregnancies starting as twins but complicated with either&#xD;
             vanishing twin syndrome or fetal demise of one twin before 14 weeks, are eligible for&#xD;
             inclusion)&#xD;
&#xD;
          -  Patient presenting with clinical suspicion of Pre-E based on one or more of the&#xD;
             following clinical signs and symptoms of Pre-E:&#xD;
&#xD;
               -  New onset increased blood pressure in otherwise normotensive patient&#xD;
&#xD;
               -  Worsening hypertension in a patient with pre-existing hypertension&#xD;
&#xD;
               -  New onset proteinuria or worsening of pre-existing proteinuria&#xD;
&#xD;
               -  Any other clinical finding typically associated with suspicion of Pre-E and&#xD;
                  requiring workup to rule-out Pre-E&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy is non-viable, as evidenced by absence of fetal cardiac activity&#xD;
&#xD;
          -  Major fetal anomaly or chromosomal aneuploidy&#xD;
&#xD;
          -  Current dialysis for kidney failure, including continuous ambulatory peritoneal&#xD;
             dialysis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Stiegler, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Progenity, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West Coast Medical Research, Inc.</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christiana Care</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Health Partners, LLC</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Discovery Clinical Research</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leavitt Clinical Research</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norton Healthcare</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Obstetrics and Gynecology Associates AMB</name>
      <address>
        <city>Silver Spring</city>
        <state>Maryland</state>
        <zip>20910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley OB-GYN Clinic, PC</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers-RWJMS</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Peter's University Hospital</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virtua Voorhees Hospital</name>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Life Medical Esthetics and Wellness, PLLC</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Total Woman Care</name>
      <address>
        <city>Elkin</city>
        <state>North Carolina</state>
        <zip>28621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>David B. Schwartz, MD, LLC</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Obstetrics &amp; Gynecology Associates, Inc.</name>
      <address>
        <city>Fairfield</city>
        <state>Ohio</state>
        <zip>45014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hilltop Obstetrics &amp; Gynecology</name>
      <address>
        <city>Franklin</city>
        <state>Ohio</state>
        <zip>45005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Ahuja and Associates OB-GYN</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drexel University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jackson Clinic, PA</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aa Ob-Gyn, Pllc</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OB-GYN North</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Corpus Christi Women's Clinic</name>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <zip>78412</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>January 22, 2020</last_update_submitted>
  <last_update_submitted_qc>January 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Proteinuria</keyword>
  <keyword>Thrombocytopenia</keyword>
  <keyword>Renal Insufficiency</keyword>
  <keyword>Impaired Liver Function</keyword>
  <keyword>Pulmonary Edema</keyword>
  <keyword>Cerebral Symptoms</keyword>
  <keyword>Visual Symptoms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Edema</mesh_term>
    <mesh_term>Vision Disorders</mesh_term>
    <mesh_term>Vision, Low</mesh_term>
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Eclampsia</mesh_term>
    <mesh_term>Proteinuria</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Thrombocytopenia</mesh_term>
    <mesh_term>Headache</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/NCT03767803
org study id: PRO-129-PREECLAMPSIA
nct id: NCT03767803
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Whole blood sample procurement study from pregnant women with signs and symptoms of
      Preeclampsia.
This multicenter non-interventional observational sample acquisition study is designed to
      acquire whole-blood samples from pregnant women who present with signs and symptoms of Pre-E
      and are in the care at an OB-GYN and/or Maternal Fetal Medicine (MFM) site, defined as
      outpatient centers, clinic sites, and medical offices.

      Study population includes subjects who are pregnant, of any race or ethnicity, 18 to 45 years
      of age, 28 0/7 to 36 6/7 weeks' gestational age with a singleton fetus and have provided
      written informed consent to provide whole blood specimens at one or more study visits.
observational model: Cohort
time perspective: Prospective
measure: Diagnosis of preeclampsia is determined by standard of care.
time frame: 3 months
description: Observational, non-interventional sample procurement study in which participants are treated per standard of care
arm group label: Positive Preeclampsia group
description: A group with diagnosis of preeclampsia within 24 hours of testing and pre-term delivery
arm group label: Study Cohort
description: A group without diagnosis of preeclampsia. Also includes a group without diagnosis of preeclampsia within 24 hours of testing, but who have subsequent worsening or re-emergence of signs and symptoms of preeclampsia, and are later diagnosed with preeclampsia and have pre-term delivery.
intervention type: Other
intervention name: Non-interventional study
description: This is an observational, non-interventional study.
arm group label: Positive Preeclampsia group
arm group label: Study Cohort
This study will collect 20 mL whole blood samples from subjects at one or more study visits.
      The whole blood will be processed to plasma and stored for testing.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Peter Stiegler, PhD
role: Study Director
affiliation: Progenity, Inc.
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country: United States
responsible party type: Sponsor
mesh term: Pulmonary Edema
mesh term: Vision Disorders
mesh term: Vision, Low
mesh term: Pre-Eclampsia
mesh term: Renal Insufficiency
mesh term: Eclampsia
mesh term: Proteinuria
mesh term: Hypertension
mesh term: Thrombocytopenia
mesh term: Headache
sharing ipd: No