<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/NCT04444791</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCPublicHealth</org_study_id>
    <nct_id>NCT04444791</nct_id>
  </id_info>
  <brief_title>Chinese Pregnant Woman Cohort Study (Offspring Follow-up)</brief_title>
  <official_title>Chinese Pregnant Woman Cohort Study (Offspring Follow-up)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College</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>
      Purpose: To investigate the growth and development status for children of 1 ~ 3 years old in&#xD;
      China, and to explore and analyze the influencing factors of infant growth. Mother's health&#xD;
      status would also be investigated simultaneously.&#xD;
&#xD;
      Methods and analysis: This is a multicenter prospective cohort study. Participants were all&#xD;
      from the Chinese Pregnant Women Cohort Study (CPWCS), which is a multicenter prospective&#xD;
      cohort study we conducted before. In simple terms, pregnant women during the first trimester&#xD;
      (5~13 weeks' gestational age) were included from 25 July 2017 to 26 November 2018. Related&#xD;
      information were collected by electronic self-administered questionnaire, including general&#xD;
      information, environmental exposure assessment, physical activity assessment, dietary and&#xD;
      nutritional assessment, depression assessment, sleep quality assessment and economic burden&#xD;
      assessment. Subsequently, objective medical information, obstetric and neonatal outcomes were&#xD;
      collected through hospital information system (HIS).&#xD;
&#xD;
      To further assess the mothers' and infants' health status, a new multicenter prospective&#xD;
      cohort study, including more than 1000 participants of the CPWCS from 5 hospitals of 5&#xD;
      different provinces in China, will be conducted. Through the electronic self-administered&#xD;
      questionnaire surveys and laboratory testing methods, information about infants' feeding,&#xD;
      sleeping, defecating, oral health, early development and common allergic diseases will be&#xD;
      collected. And we will also assess mothers' current health habits and status, such as&#xD;
      sleeping, diet, anxiety, physical activity, and oral health. SAS statistical software will be&#xD;
      used for data analysis.&#xD;
&#xD;
      Ethics and Dissemination Permission for the study was obtained from Chinese Academy of&#xD;
      Medical Sciences and Peking Union Medical College. Ethics approval was obtained from the&#xD;
      Ethics Review Committee of Department of Scientific Research, School of Basic Medicine,&#xD;
      Peking Union Medical College, Beijing, China. The results will be published in peer-reviewed&#xD;
      journals or disseminated through conference presentations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 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>Infants' and young children's feeding situation</measure>
    <time_frame>2020.8.1-2020.12.1</time_frame>
    <description>The mother will report these questions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infants' sleeping conditions</measure>
    <time_frame>2020.8.1-2020.12.1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Infants' defecation situation</measure>
    <time_frame>2020.8.1-2020.12.1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Infants' oral development</measure>
    <time_frame>2020.8.1-2020.12.1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Infants' early development</measure>
    <time_frame>2020.8.1-2020.12.1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mother' knowledge of infant oral health care</measure>
    <time_frame>2020.8.1-2020.12.1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Infants' physical health (asthma, allergies, autism)</measure>
    <time_frame>2020.8.1-2020.12.1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mothers' physical activity</measure>
    <time_frame>2020.8.1-2020.12.1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mothers' dietary patterns</measure>
    <time_frame>2020.8.1-2020.12.1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mothers' lifestyle (smoking, sleeping)</measure>
    <time_frame>2020.8.1-2020.12.1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mothers' anxiety condition</measure>
    <time_frame>2020.8.1-2020.12.1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mothers' oral health</measure>
    <time_frame>2020.8.1-2020.12.1</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1978</enrollment>
  <condition>Pregnancy Related</condition>
  <condition>Pregnancy Disease</condition>
  <condition>Pregnancy</condition>
  <condition>Infant Development</condition>
  <condition>Risk Factor</condition>
  <condition>Infant</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <description>This cohort study only set up one group. The habits and health status of mothers and their offspring will be followed up and observed. The participants will be divided into more than one group according to the variables (e.g. age, physical activity, dietary patterns, sleep quality.).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        In the Chinese Pregnant Women Cohort Study (CPWCS), more than 9000 pregnant women were&#xD;
        recruited from 25 July 2017 to 26 November 2018 during their routine antenatal check at the&#xD;
        first trimester. Five hospitals of 5 different provinces in China with certain working&#xD;
        foundation, good cooperation and high follow-up rate of pregnant women in the CPWCS were&#xD;
        selected as study sites for the new cohort of the Chinese Pregnant Women Cohort&#xD;
        Study-Offspring Follow-up (CPWCS-OF). From these 5 hospitals, mothers with the baseline&#xD;
        information, first trimester questionnaire, delivery outcomes, and neonatal outcomes data&#xD;
        completed, and had live birth and singleton were included. According to the inclusion and&#xD;
        exclusion criteria, 1978 mothers with their infants were selected as the research objects.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. participated in the CPWCS and were pregnant women included in the previous cohort;&#xD;
&#xD;
          2. the baseline, first trimester, delivery outcomes, and neonatal outcomes data in the&#xD;
             CPWCS were complete;&#xD;
&#xD;
          3. live birth and singleton in the CPWCS;&#xD;
&#xD;
          4. participate in the CPWCS-OF with child born in the CPWCS willingly;&#xD;
&#xD;
          5. able to complete the questionnaire;&#xD;
&#xD;
          6. resident in the study area;&#xD;
&#xD;
          7. signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. subjects not included in the CPWCS;&#xD;
&#xD;
          2. incomplete data in either of baseline, first trimester, delivery outcomes, and&#xD;
             neonatal outcomes in the CPWCS;&#xD;
&#xD;
          3. pregnancy outcomes in the CPWCS were not singleton (abortion, stillbirth, twins,&#xD;
             multiple births);&#xD;
&#xD;
          4. no longer resident in the study area;&#xD;
&#xD;
          5. the child has died;&#xD;
&#xD;
          6. the mother currently has mental problems and cannot cooperate well with the research.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Zhao Jian, Doctor</last_name>
    <phone>86+15645120652</phone>
    <email>15645120652@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>School of Public Health, Peking Union Medical College</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 20, 2020</last_update_submitted>
  <last_update_submitted_qc>June 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College</investigator_affiliation>
    <investigator_full_name>Yu Jiang</investigator_full_name>
    <investigator_title>School of Public Health</investigator_title>
  </responsible_party>
  <!-- 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/NCT04444791
org study id: PUMCPublicHealth
nct id: NCT04444791
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Purpose: To investigate the growth and development status for children of 1 ~ 3 years old in
      China, and to explore and analyze the influencing factors of infant growth. Mother's health
      status would also be investigated simultaneously.

      Methods and analysis: This is a multicenter prospective cohort study. Participants were all
      from the Chinese Pregnant Women Cohort Study (CPWCS), which is a multicenter prospective
      cohort study we conducted before. In simple terms, pregnant women during the first trimester
      (5~13 weeks' gestational age) were included from 25 July 2017 to 26 November 2018. Related
      information were collected by electronic self-administered questionnaire, including general
      information, environmental exposure assessment, physical activity assessment, dietary and
      nutritional assessment, depression assessment, sleep quality assessment and economic burden
      assessment. Subsequently, objective medical information, obstetric and neonatal outcomes were
      collected through hospital information system (HIS).

      To further assess the mothers' and infants' health status, a new multicenter prospective
      cohort study, including more than 1000 participants of the CPWCS from 5 hospitals of 5
      different provinces in China, will be conducted. Through the electronic self-administered
      questionnaire surveys and laboratory testing methods, information about infants' feeding,
      sleeping, defecating, oral health, early development and common allergic diseases will be
      collected. And we will also assess mothers' current health habits and status, such as
      sleeping, diet, anxiety, physical activity, and oral health. SAS statistical software will be
      used for data analysis.

      Ethics and Dissemination Permission for the study was obtained from Chinese Academy of
      Medical Sciences and Peking Union Medical College. Ethics approval was obtained from the
      Ethics Review Committee of Department of Scientific Research, School of Basic Medicine,
      Peking Union Medical College, Beijing, China. The results will be published in peer-reviewed
      journals or disseminated through conference presentations.
observational model: Cohort
time perspective: Prospective
measure: Infants' and young children's feeding situation
time frame: 2020.8.1-2020.12.1
description: The mother will report these questions.
measure: Infants' sleeping conditions
time frame: 2020.8.1-2020.12.1
measure: Infants' defecation situation
time frame: 2020.8.1-2020.12.1
measure: Infants' oral development
time frame: 2020.8.1-2020.12.1
measure: Infants' early development
time frame: 2020.8.1-2020.12.1
measure: Mother' knowledge of infant oral health care
time frame: 2020.8.1-2020.12.1
measure: Infants' physical health (asthma, allergies, autism)
time frame: 2020.8.1-2020.12.1
measure: Mothers' physical activity
time frame: 2020.8.1-2020.12.1
measure: Mothers' dietary patterns
time frame: 2020.8.1-2020.12.1
measure: Mothers' lifestyle (smoking, sleeping)
time frame: 2020.8.1-2020.12.1
measure: Mothers' anxiety condition
time frame: 2020.8.1-2020.12.1
measure: Mothers' oral health
time frame: 2020.8.1-2020.12.1
arm group label: Cohort
description: This cohort study only set up one group. The habits and health status of mothers and their offspring will be followed up and observed. The participants will be divided into more than one group according to the variables (e.g. age, physical activity, dietary patterns, sleep quality.).
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Zhao Jian, Doctor
phone: 86+15645120652
email: 15645120652@163.com
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College
investigator full name: Yu Jiang
investigator title: School of Public Health