<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/NCT02990767</url>
  </required_header>
  <id_info>
    <org_study_id>ShanghaiFMIH-FMU3</org_study_id>
    <nct_id>NCT02990767</nct_id>
  </id_info>
  <brief_title>Prediction of Early Pre-eclampsia From Maternal Factors, Biophysical and Biochemical Markers at First Trimester</brief_title>
  <official_title>Prediction of Early Pre-eclampsia From Maternal Factors, Biophysical and Biochemical Markers at First Trimester</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai First Maternity and Infant Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai First Maternity and Infant Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of this study are to develop algorithms based on a combination of maternal factors,&#xD;
      uterine artery PI, MAP and serum biomarkers to estimate patient-specific risks for early&#xD;
      Preeclampsia (PE) and to evaluate the screening performance of such algorithms in twins.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preeclampsia (PE) is still a leading cause of fetal and maternal morbidity and mortality with&#xD;
      an incidence of 3-5% worldwide. Despite intensive research efforts the pathogenesis of the&#xD;
      disease is still unknown but it is likely to be multifactorial.Clinical risk factors&#xD;
      traditionally have been used to identify women at high risk of developing preeclampsia,and&#xD;
      biophysical factors that may help predict hypertensive disorders of pregnancy.In&#xD;
      addition,changes in the serum concentrations of angiogenic and antiangiogenic factors are&#xD;
      implied in the pathogenesis of PE and have possible relevance in the diagnosis of the&#xD;
      disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2017</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>Early preeclampsia</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Selective intrauterine fetal growth restriction</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Pre-Eclampsia</condition>
  <arm_group>
    <arm_group_label>observational women</arm_group_label>
    <description>collecting maternal factors, biophysical and biochemical markers at 11-13 weeks of gestation.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Twin pregnancies were recruited prospectively from women attending their routine first&#xD;
        hospital visit in Shanghai First Maternity and Infant Hospital between December 2016 and&#xD;
        December 2018.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  twins pregnancies delivering a phenotypically normal stillbirth or live birth at or&#xD;
             after 24 weeks of gestation.&#xD;
&#xD;
          -  twins pregnancies at at 11-14 weeks of gestation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancies with major fetal abnormalities and those ending in termination,&#xD;
             miscarriage or fetal death before 24 weeks&#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_contact>
    <last_name>Luming Sun, PhD</last_name>
    <phone>021-20261151</phone>
    <email>luming_sun@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai First Maternity and Infant Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200051</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luming Sun, PhD</last_name>
      <phone>021-20261151</phone>
      <email>luming_sun@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 9, 2016</last_update_submitted>
  <last_update_submitted_qc>December 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</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>Eclampsia</mesh_term>
    <mesh_term>Pre-Eclampsia</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/NCT02990767
org study id: ShanghaiFMIH-FMU3
nct id: NCT02990767
lead sponsor: 
has dmc: No
The aims of this study are to develop algorithms based on a combination of maternal factors,
      uterine artery PI, MAP and serum biomarkers to estimate patient-specific risks for early
      Preeclampsia (PE) and to evaluate the screening performance of such algorithms in twins.
Preeclampsia (PE) is still a leading cause of fetal and maternal morbidity and mortality with
      an incidence of 3-5% worldwide. Despite intensive research efforts the pathogenesis of the
      disease is still unknown but it is likely to be multifactorial.Clinical risk factors
      traditionally have been used to identify women at high risk of developing preeclampsia,and
      biophysical factors that may help predict hypertensive disorders of pregnancy.In
      addition,changes in the serum concentrations of angiogenic and antiangiogenic factors are
      implied in the pathogenesis of PE and have possible relevance in the diagnosis of the
      disease.
observational model: Cohort
time perspective: Prospective
measure: Early preeclampsia
time frame: 1 year
measure: Selective intrauterine fetal growth restriction
time frame: 1 year
arm group label: observational women
description: collecting maternal factors, biophysical and biochemical markers at 11-13 weeks of gestation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Luming Sun, PhD
phone: 021-20261151
email: luming_sun@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Eclampsia
mesh term: Pre-Eclampsia
sharing ipd: Undecided