<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/NCT03038555</url>
  </required_header>
  <id_info>
    <org_study_id>2016YFC1000405</org_study_id>
    <nct_id>NCT03038555</nct_id>
  </id_info>
  <brief_title>China Obstetrics Alliance Cohort Study</brief_title>
  <acronym>COACS</acronym>
  <official_title>The Study of Prevention and Intervention Strategy of Gestational Diseases Based on Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Third Affiliated Hospital of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Obstetrics &amp; Gynecology Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tongji Medical College of Huazhong University of Science &amp; Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xinjiang Maternity &amp; Children Health Care Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Third Affiliated Hospital of Guangzhou Medical University</source>
  <brief_summary>
    <textblock>
      Preeclampsia (PE) is one of a common type of hypertensive disorder complicating pregnancy&#xD;
      (HDCP). It is a class of clinical syndromes which shows relevant symptoms, hypertension and&#xD;
      proteinuria after 20 weeks pregnant as main characteristic, and may accompany with fetal&#xD;
      anomaly and systemic multi-system organs damage. Several complications, such as eclamptic&#xD;
      seizures, coma, intracranial hemorrhage (ICH), cardiac failure, pneumonedema, hepatic&#xD;
      failure, kidney failure, placental abruption and disseminated intravascular coagulation&#xD;
      (DIC), may be threat to the life of the mother as well as fetal. Thus, the disease is one of&#xD;
      the core issues that cause the maternal and perinatal death. Morbidity of PE is approximately&#xD;
      3% to 5%. Morbidity has significant differences between different populations. According to&#xD;
      the data, from 1995 to 2004, HDCP morbidity in four hospitals in Guangzhou was 5.78%, and in&#xD;
      the HDCP, mild preeclampsia and severe preeclampsia were accounted for 72.22% and 27.78%&#xD;
      respectively. Meanwhile, HDCP morbidity decreased from 9.4% (1984 to 1989) to 5.57% (1989 to&#xD;
      1998).&#xD;
&#xD;
      In 1996, the American Congress of Obstetricians and Gynecologists (ACOG) gave new&#xD;
      classification of HDCP based on the characteristic of disease symptoms, divide into five&#xD;
      groups; gestational hypertension, preeclampsia, eclampsia, chronic hypertension complicated&#xD;
      with preeclampsia and chronic hypertension. The pathogenesis of PE remains unclear so far.&#xD;
      The frequent sight is that PE caused by multiple reactions by a number of factors affect.&#xD;
      Physiologically, mainly altered of PE is increased blood viscosity and systemic vascular&#xD;
      spasm which cause hypoxic-ischemic of multiple key organs, such as the placenta, kidney,&#xD;
      liver and brain. The research theory includes abnormal trophoblast invasion, immune response&#xD;
      abnormal or increase, genetic susceptibility, coagulation disorders or thrombophilia,&#xD;
      abnormal angiogenesis, endothelial cell damage, abnormal levels of carbonic oxide, increase&#xD;
      of oxygen radical, abnormal metabolism of calcium ion, heterotrophia and so on. However,&#xD;
      there are numbers of epidemiologic study have analyzed high risk factor of PE which provides&#xD;
      significant medical evidence of prevention, early diagnosis and early treatment for PE, there&#xD;
      is only little study focus on susceptibility gene and pathogenic genetic variation. Nowadays,&#xD;
      there are numerous clinical phenotype are considered to exist, different phenotype gives&#xD;
      different inheritance and epigenetics. Thus, our group will examine the onset of type and&#xD;
      characteristics of PE by a retrospective cohort study to discuss if susceptibility gene and&#xD;
      pathogenic genetic variation were existing in PE patients, also to find the relativity&#xD;
      between clinical phenotype and genotype. Moreover, this study is trying to reach the effect&#xD;
      of PE on the patients' health as well as their children. Thus, can predict the health status&#xD;
      of PE patients and their children, and so can prevent (avoid or delay) of the patients from&#xD;
      late complications and disease in their children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. All female staff that works, examination and delivery in the Third Affiliated Hospital&#xD;
           of Guangzhou Medical University from Dec 1995 to Dec 2016 should be in the cohort.&#xD;
           Collect all information; include clinical examination and medical examination, science&#xD;
           the subject work in the hospital. Collect the perinatal data; include obstetric&#xD;
           information, past medical history, family history and so on. Build the database and&#xD;
           analyze the relative factor.&#xD;
&#xD;
        2. From all subjects, choose subjects that have got PE before as the experimental group.&#xD;
           Pair the same age, gestational weeks, children's gender and healthy subject as a control&#xD;
           group in the ratio of 1:1. The control group should exclude subject that have ever got&#xD;
           heart or lung diseases, diabetes, chronic nephrosis, immune disease and other hereditary&#xD;
           disease. Store the blood samples (serum, blood and plasma) of both the experimental&#xD;
           group and control group and their children. Compare the differences of functional&#xD;
           parameter between two groups both before and after delivery, which include blood&#xD;
           pressure, blood glucose and blood lipids. Moreover, compare the function of heart, liver&#xD;
           and kidney and genetic material (DNA and RNA).&#xD;
&#xD;
        3. Diagnostic standard of PE refer to People's Medical Publishing House &lt;Obstetrics and&#xD;
           Gynecology&gt; 8th edition. Confirm the diagnostic standard of HDCP and relative disease&#xD;
           include PE will make sure the veracity and uniformity of diagnosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>track the difference between preeclampsia and normal</measure>
    <time_frame>2 years</time_frame>
    <description>Our main judgement criterion allowing to distinguish patients with preeclampsia from those without disease</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">900</enrollment>
  <condition>Preeclampsia</condition>
  <arm_group>
    <arm_group_label>Disease group (subject to strategy)</arm_group_label>
    <description>Choose subjects that have ever got PE before as the diseases group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Pair the same age, gestational weeks, children's gender and healthy subject as a control group in the ratio of 1:1. The control group should exclude subject that have ever got heart or lung diseases, diabetes, chronic nephrosis, immune disease and other hereditary disease.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Store the blood samples (serum, blood and plasma) of both the experimental group and control&#xD;
      group and their children.&#xD;
&#xD;
      These additional samples were be centrifuged and treated and stored in a collection of&#xD;
      biological samples of total serum and plasma and blood at the Biobank of The Third Affiliated&#xD;
      Hospital of Guangzhou Medical University at -80 ° C&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Choose subjects that have got PE before as the experimental group. Pair the same age,&#xD;
        gestational weeks, children's gender and healthy subject as a control group in the ratio of&#xD;
        1:1. The control group should exclude subject that have ever got heart or lung diseases,&#xD;
        diabetes, chronic nephrosis, immune disease and other hereditary disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Choose subjects that have got PE before as the experimental group. Pair the same age,&#xD;
             gestational weeks, children's gender and healthy subject as a control group in the&#xD;
             ratio of 1:1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject that have ever got heart or lung diseases, diabetes, chronic nephrosis, immune&#xD;
             disease and other hereditary disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Guangzhou Institute of Obstetrics &amp; Gynecology</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510150</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Medical College Huazhong University of Science &amp; Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandong Provincial Hospital</name>
      <address>
        <city>Jinan Shi</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xinjiang Maternity &amp; Children Health Care Hospital</name>
      <address>
        <city>Urumqi</city>
        <state>Xinjiang</state>
        <zip>96595</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Obstetrics and Gynecology Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 28, 2017</last_update_submitted>
  <last_update_submitted_qc>January 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Third Affiliated Hospital of Guangzhou Medical University</investigator_affiliation>
    <investigator_full_name>Dunjin Chen</investigator_full_name>
    <investigator_title>Guangzhou Institute of Obstetrics &amp; Gynecology</investigator_title>
  </responsible_party>
  <keyword>Medical staff</keyword>
  <keyword>preeclampsia</keyword>
  <keyword>cohort study</keyword>
  <keyword>further effect</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03038555
org study id: 2016YFC1000405
nct id: NCT03038555
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
Preeclampsia (PE) is one of a common type of hypertensive disorder complicating pregnancy
      (HDCP). It is a class of clinical syndromes which shows relevant symptoms, hypertension and
      proteinuria after 20 weeks pregnant as main characteristic, and may accompany with fetal
      anomaly and systemic multi-system organs damage. Several complications, such as eclamptic
      seizures, coma, intracranial hemorrhage (ICH), cardiac failure, pneumonedema, hepatic
      failure, kidney failure, placental abruption and disseminated intravascular coagulation
      (DIC), may be threat to the life of the mother as well as fetal. Thus, the disease is one of
      the core issues that cause the maternal and perinatal death. Morbidity of PE is approximately
      3% to 5%. Morbidity has significant differences between different populations. According to
      the data, from 1995 to 2004, HDCP morbidity in four hospitals in Guangzhou was 5.78%, and in
      the HDCP, mild preeclampsia and severe preeclampsia were accounted for 72.22% and 27.78%
      respectively. Meanwhile, HDCP morbidity decreased from 9.4% (1984 to 1989) to 5.57% (1989 to
      1998).

      In 1996, the American Congress of Obstetricians and Gynecologists (ACOG) gave new
      classification of HDCP based on the characteristic of disease symptoms, divide into five
      groups; gestational hypertension, preeclampsia, eclampsia, chronic hypertension complicated
      with preeclampsia and chronic hypertension. The pathogenesis of PE remains unclear so far.
      The frequent sight is that PE caused by multiple reactions by a number of factors affect.
      Physiologically, mainly altered of PE is increased blood viscosity and systemic vascular
      spasm which cause hypoxic-ischemic of multiple key organs, such as the placenta, kidney,
      liver and brain. The research theory includes abnormal trophoblast invasion, immune response
      abnormal or increase, genetic susceptibility, coagulation disorders or thrombophilia,
      abnormal angiogenesis, endothelial cell damage, abnormal levels of carbonic oxide, increase
      of oxygen radical, abnormal metabolism of calcium ion, heterotrophia and so on. However,
      there are numbers of epidemiologic study have analyzed high risk factor of PE which provides
      significant medical evidence of prevention, early diagnosis and early treatment for PE, there
      is only little study focus on susceptibility gene and pathogenic genetic variation. Nowadays,
      there are numerous clinical phenotype are considered to exist, different phenotype gives
      different inheritance and epigenetics. Thus, our group will examine the onset of type and
      characteristics of PE by a retrospective cohort study to discuss if susceptibility gene and
      pathogenic genetic variation were existing in PE patients, also to find the relativity
      between clinical phenotype and genotype. Moreover, this study is trying to reach the effect
      of PE on the patients' health as well as their children. Thus, can predict the health status
      of PE patients and their children, and so can prevent (avoid or delay) of the patients from
      late complications and disease in their children.
1. All female staff that works, examination and delivery in the Third Affiliated Hospital
           of Guangzhou Medical University from Dec 1995 to Dec 2016 should be in the cohort.
           Collect all information; include clinical examination and medical examination, science
           the subject work in the hospital. Collect the perinatal data; include obstetric
           information, past medical history, family history and so on. Build the database and
           analyze the relative factor.

        2. From all subjects, choose subjects that have got PE before as the experimental group.
           Pair the same age, gestational weeks, children's gender and healthy subject as a control
           group in the ratio of 1:1. The control group should exclude subject that have ever got
           heart or lung diseases, diabetes, chronic nephrosis, immune disease and other hereditary
           disease. Store the blood samples (serum, blood and plasma) of both the experimental
           group and control group and their children. Compare the differences of functional
           parameter between two groups both before and after delivery, which include blood
           pressure, blood glucose and blood lipids. Moreover, compare the function of heart, liver
           and kidney and genetic material (DNA and RNA).

        3. Diagnostic standard of PE refer to People's Medical Publishing House <Obstetrics and
           Gynecology> 8th edition. Confirm the diagnostic standard of HDCP and relative disease
           include PE will make sure the veracity and uniformity of diagnosis.
observational model: Cohort
time perspective: Retrospective
measure: track the difference between preeclampsia and normal
time frame: 2 years
description: Our main judgement criterion allowing to distinguish patients with preeclampsia from those without disease
arm group label: Disease group (subject to strategy)
description: Choose subjects that have ever got PE before as the diseases group.
arm group label: Control group
description: Pair the same age, gestational weeks, children's gender and healthy subject as a control group in the ratio of 1:1. The control group should exclude subject that have ever got heart or lung diseases, diabetes, chronic nephrosis, immune disease and other hereditary disease.
Store the blood samples (serum, blood and plasma) of both the experimental group and control
      group and their children.

      These additional samples were be centrifuged and treated and stored in a collection of
      biological samples of total serum and plasma and blood at the Biobank of The Third Affiliated
      Hospital of Guangzhou Medical University at -80 ° C
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The Third Affiliated Hospital of Guangzhou Medical University
investigator full name: Dunjin Chen
investigator title: Guangzhou Institute of Obstetrics & Gynecology
mesh term: Pre-Eclampsia