<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/NCT04486456</url>
  </required_header>
  <id_info>
    <org_study_id>ERIC STUDY</org_study_id>
    <nct_id>NCT04486456</nct_id>
  </id_info>
  <brief_title>Epidemiological Study on Anemia and Iron Deficiency in Pregnancy in Medical Institutions in Some Areas of China</brief_title>
  <official_title>Epidemiological Study on Anemia and Iron Deficiency in Pregnancy in Medical Institutions in Some Areas of China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University First Hospital</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>
      The purpose of this study is to describe the prevalence of anemia and iron deficiency in&#xD;
      pregnancy through a multi-center, prospective follow-up study . To explore the influence&#xD;
      factors of anemia and iron deficiency in pregnancy; to explore the influence of anemia and&#xD;
      iron deficiency in pregnancy on maternal and fetal outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To understand the epidemiological characteristics of anemia and iron deficiency in&#xD;
           pregnancy and describe the epidemiological situation of anemia and iron deficiency.&#xD;
&#xD;
        2. To explore the influence factors of anemia and iron deficiency in pregnancy.&#xD;
&#xD;
        3. To explore the influence of anemia and iron deficiency during pregnancy on the pregnancy&#xD;
           outcome of mothers and infants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">August 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>Hb</measure>
    <time_frame>Completed by observation，an average of 1 year</time_frame>
    <description>Proportion of patients with Hb&lt;110g/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SF</measure>
    <time_frame>Completed by observation，an average of 1 year</time_frame>
    <description>Proportion of patients with SF&lt;20μg/L</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20000</enrollment>
  <condition>Prevalence</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnancy patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Regular prenatal check-ups were conducted in the hospitals participating in the study,&#xD;
             and pregnant women who planned to give birth in hospital were established a maternity&#xD;
             health manual&#xD;
&#xD;
          -  18 years and older&#xD;
&#xD;
          -  Patients have to agree to participate by signing a consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have severe chronic diseases with Pre-pregnancy&#xD;
&#xD;
          -  Suffer from severe mental illness&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Xia H Yang</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Peking University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Song X Zhang</last_name>
    <phone>13901024399</phone>
    <email>1033341681@qq.com</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Huixia Yang</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <keyword>Iron deficiency</keyword>
  <keyword>Anemia during pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</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/NCT04486456
org study id: ERIC STUDY
nct id: NCT04486456
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to describe the prevalence of anemia and iron deficiency in
      pregnancy through a multi-center, prospective follow-up study . To explore the influence
      factors of anemia and iron deficiency in pregnancy; to explore the influence of anemia and
      iron deficiency in pregnancy on maternal and fetal outcomes.
1. To understand the epidemiological characteristics of anemia and iron deficiency in
           pregnancy and describe the epidemiological situation of anemia and iron deficiency.

        2. To explore the influence factors of anemia and iron deficiency in pregnancy.

        3. To explore the influence of anemia and iron deficiency during pregnancy on the pregnancy
           outcome of mothers and infants.
observational model: Cohort
time perspective: Prospective
measure: Hb
time frame: Completed by observation，an average of 1 year
description: Proportion of patients with Hb<110g/L
measure: SF
time frame: Completed by observation，an average of 1 year
description: Proportion of patients with SF<20μg/L
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
last name: Xia H Yang
role: Principal Investigator
affiliation: The First Affiliated Hospital of Peking University
last name: Song X Zhang
phone: 13901024399
email: 1033341681@qq.com
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Huixia Yang
investigator title: Principle investigator
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
sharing ipd: Undecided