<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/NCT03821922</url>
  </required_header>
  <id_info>
    <org_study_id>FGF23</org_study_id>
    <nct_id>NCT03821922</nct_id>
  </id_info>
  <brief_title>Fibroblast Growth Factor 23 and Hypertensive Disorder Complicating Pregnancy</brief_title>
  <official_title>Expression of Endocrine Fibroblast Growth Factor 23 and Hypertensive Disorder Complicating Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital, Sun Yat-Sen University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Hypertensive disorder complicating pregnancy is a set of diseases of pregnancy coexisting&#xD;
      with elevated blood pressure. The incidence of it is approximately 5-12%. Pregnancy-induced&#xD;
      hypertension is a pregnancy-specific disorder, severely impairing both maternal and fetal&#xD;
      health, and the major cause of maternal and perinatal mortality rate increased. But so far,&#xD;
      the specific etiology is still unclear.&#xD;
&#xD;
      Recently, fibroblast growth factor 23 (FGF23) has emerged as key endocrine regulators of the&#xD;
      metabolism of vitamin D and calcium and phosphorus by combining FGFR-α- Klotho receptor&#xD;
      complex. Current studies showed that α- Klotho involved the development of gestational&#xD;
      hypertension via the production of endothelial nitric oxide, angiogenesis, and the formation&#xD;
      of antioxidant enzymes. On the other hand, vitamin D deficiency during pregnancy has an&#xD;
      adverse impact on maternal and fetal health, including gestational hypertension. Therefore,&#xD;
      the relationship of the expression of FGF23 and the development of gestational hypertension&#xD;
      has attracted the attention of relevant scholars.&#xD;
&#xD;
      The aim of this study is to detect the difference of the expression of FGF23 between the&#xD;
      hypertensive women and normal pregnant women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      100 pregnant women with hypertensive disorder complicating pregnancy and 200 normal pregnant&#xD;
      control women matched for maternal and gestational age were enrolled in the study. All the&#xD;
      subjects underwent antepartum screening in the First Affiliated Hospital of Sun Yat-sen&#xD;
      University. Blood samples were obtained after overnight fasting at the first, second and&#xD;
      third trimester respectively. Serum FGF23 levels were determined by enzyme-linked&#xD;
      immunosorbent assay (ELISA) and were correlated with anthropometric, metabolic, and endocrine&#xD;
      parameters.&#xD;
&#xD;
      Data were analyzed by SPSS 20.0 database. The results were expressed as mean ± standard&#xD;
      deviations or median with interquartile range. Differences between groups were assessed by&#xD;
      Student's unpaired t test, Mann-Whitney U test, or Chi-square test as appropriate.&#xD;
      Correlation analysis was performed using the Spearman rank correlation method. To identify&#xD;
      independent relationships and adjust the effects of covariates, multiple linear regression&#xD;
      analyses were performed. P values of &lt;0.05 were considered significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>Expression of FGF23</measure>
    <time_frame>up to 14 weeks</time_frame>
    <description>expression of FGF23 in different groups in mmol/l</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Expression of FGF23</measure>
    <time_frame>up to 28 weeks</time_frame>
    <description>expression of FGF23 in different groups in mmol/l</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Expression of FGF23</measure>
    <time_frame>up to 40 weeks</time_frame>
    <description>expression of FGF23 in different groups in mmol/l</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Hypertension, Pregnancy-Induced</condition>
  <arm_group>
    <arm_group_label>pregnancy-induced pregnancy</arm_group_label>
    <description>Those women (subjects) with pregnancy-induced pregnancy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Those healthy pregnant women</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        university hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with singleton pregnancy;&#xD;
&#xD;
          -  Regular antenatal examination from the first trimester;&#xD;
&#xD;
          -  Give birth in the university hospital (The 1st affiliated hospital of Sun Yat-sen&#xD;
             University)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years old;&#xD;
&#xD;
          -  Older than 40 years old;&#xD;
&#xD;
          -  Multiple pregnancy;&#xD;
&#xD;
          -  Complicated with other diseases such as hypertension, eclampsia, thyroid diseases,&#xD;
             etc.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zilian Wang, M.D,PhD</last_name>
    <role>Study Director</role>
    <affiliation>O&amp;G Department of the 1st affiliated hospital of Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dongyu Wang, M.D,PhD</last_name>
    <phone>86-020-87755766</phone>
    <email>dongyugd@aliyun.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dongyu Wang, M.D., PhD</last_name>
      <phone>86-020-87755766</phone>
      <email>dongyugd@aliyun.com</email>
    </contact>
    <investigator>
      <last_name>Dongyu Wang, M.D.,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 26, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Dongyu Wang</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hypertension, Pregnancy-Induced</keyword>
  <keyword>FGF23</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Hypertension, Pregnancy-Induced</mesh_term>
    <mesh_term>Hypertension</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/NCT03821922
org study id: FGF23
nct id: NCT03821922
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Hypertensive disorder complicating pregnancy is a set of diseases of pregnancy coexisting
      with elevated blood pressure. The incidence of it is approximately 5-12%. Pregnancy-induced
      hypertension is a pregnancy-specific disorder, severely impairing both maternal and fetal
      health, and the major cause of maternal and perinatal mortality rate increased. But so far,
      the specific etiology is still unclear.

      Recently, fibroblast growth factor 23 (FGF23) has emerged as key endocrine regulators of the
      metabolism of vitamin D and calcium and phosphorus by combining FGFR-α- Klotho receptor
      complex. Current studies showed that α- Klotho involved the development of gestational
      hypertension via the production of endothelial nitric oxide, angiogenesis, and the formation
      of antioxidant enzymes. On the other hand, vitamin D deficiency during pregnancy has an
      adverse impact on maternal and fetal health, including gestational hypertension. Therefore,
      the relationship of the expression of FGF23 and the development of gestational hypertension
      has attracted the attention of relevant scholars.

      The aim of this study is to detect the difference of the expression of FGF23 between the
      hypertensive women and normal pregnant women.
100 pregnant women with hypertensive disorder complicating pregnancy and 200 normal pregnant
      control women matched for maternal and gestational age were enrolled in the study. All the
      subjects underwent antepartum screening in the First Affiliated Hospital of Sun Yat-sen
      University. Blood samples were obtained after overnight fasting at the first, second and
      third trimester respectively. Serum FGF23 levels were determined by enzyme-linked
      immunosorbent assay (ELISA) and were correlated with anthropometric, metabolic, and endocrine
      parameters.

      Data were analyzed by SPSS 20.0 database. The results were expressed as mean ± standard
      deviations or median with interquartile range. Differences between groups were assessed by
      Student's unpaired t test, Mann-Whitney U test, or Chi-square test as appropriate.
      Correlation analysis was performed using the Spearman rank correlation method. To identify
      independent relationships and adjust the effects of covariates, multiple linear regression
      analyses were performed. P values of <0.05 were considered significant.
observational model: Case-Control
time perspective: Prospective
measure: Expression of FGF23
time frame: up to 14 weeks
description: expression of FGF23 in different groups in mmol/l
measure: Expression of FGF23
time frame: up to 28 weeks
description: expression of FGF23 in different groups in mmol/l
measure: Expression of FGF23
time frame: up to 40 weeks
description: expression of FGF23 in different groups in mmol/l
arm group label: pregnancy-induced pregnancy
description: Those women (subjects) with pregnancy-induced pregnancy.
arm group label: Control
description: Those healthy pregnant women
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zilian Wang, M.D,PhD
role: Study Director
affiliation: O&G Department of the 1st affiliated hospital of Sun Yat-sen University
last name: Dongyu Wang, M.D,PhD
phone: 86-020-87755766
email: dongyugd@aliyun.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital, Sun Yat-Sen University
investigator full name: Dongyu Wang
investigator title: Principal Investigator
mesh term: Pregnancy Complications
mesh term: Hypertension, Pregnancy-Induced
mesh term: Hypertension