<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/NCT03814395</url>
  </required_header>
  <id_info>
    <org_study_id>NNSF81703240</org_study_id>
    <secondary_id>81703240</secondary_id>
    <nct_id>NCT03814395</nct_id>
  </id_info>
  <brief_title>Peking University Birth Cohort in Tongzhou</brief_title>
  <acronym>PKUBC-T</acronym>
  <official_title>Peking University Birth Cohort in Tongzhou</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Natural Science Foundation of China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University</source>
  <oversight_info>
    <has_dmc>No</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>
      The PKUBC-T is a prospective cohort study carried out in Tongzhou district of Beijing, China.&#xD;
      The primary aim of this study is to investigate the short-term and long-term effects of&#xD;
      pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding&#xD;
      environmental, nutritional and lifestyle exposures as well as short-term and long-term health&#xD;
      outcomes of mothers and their children from birth to 6 years old. Biological samples&#xD;
      including blood and tissue samples are also collected from mothers and their children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maternal and child health is of great concern globally. Early life phase of a fetus and&#xD;
      infant is a critical period for the development of health and disease in the whole life.&#xD;
      Exposure of negative environmental, nutritional and lifestyle factors in pregnant women&#xD;
      during this period can have adverse effects on fetal and infant. In addition, for mothers,&#xD;
      complications during pregnancy could also have a negative effect on long-term health of&#xD;
      mothers, such as diabetes, hypertension. Thus, the Peking University Birth Cohort in Tongzhou&#xD;
      is primarily aimed to investigate the short-term and long-term effects of pre-pregnant and&#xD;
      prenatal exposure on maternal and child health. Data are collected regarding environmental,&#xD;
      nutritional and lifestyle exposures as well as short-term and long-term health outcomes of&#xD;
      mothers and their children from birth to 6 years old. Biological samples including blood and&#xD;
      tissue samples are also collected from mothers and their children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 28, 2018</start_date>
  <completion_date type="Anticipated">August 28, 2025</completion_date>
  <primary_completion_date type="Actual">August 27, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Numbers of participants with pregnancy complications</measure>
    <time_frame>At delivery</time_frame>
    <description>Including gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Numbers of participants with adverse pregnancy outcomes</measure>
    <time_frame>At delivery</time_frame>
    <description>Including preterm birth, low birth weight, macrosomia, abortion, stillbirth, and birth defects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight in kilogram changes during childhood</measure>
    <time_frame>At birth and age at 6 weeks, 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years</time_frame>
    <description>Measured by health professionals in clinic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height in centimeter changes during childhood</measure>
    <time_frame>At birth and age at 6 weeks, 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years</time_frame>
    <description>Measured by health professionals in clinic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early Child development 1</measure>
    <time_frame>Age at 6 weeks and 3 years</time_frame>
    <description>Measured by Ages&amp;Stages Questionnaires (ASQ).There are 6 questions in each of 5 domains of development: communication, gross motor, fine motor, problem-solving skills, and adaptive skills. Each question is given a 10 (yes), 5 (sometimes), or 0 (not yet) score according to the parents' answers. The sum scores (range from 0 to 300) and scores for each domain (range from 0 to 60) are calculated. Chinese norms are available for each domain, and any domain screened &lt;2 SDs below the mean is considered a positive screening. A higher ASQ score means better development.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early Child development 2</measure>
    <time_frame>Age at 8-12 months</time_frame>
    <description>Measured by Denver Developmental Screening Test (DDST). DDST comprises 125 test items grouped into four domains of child development: 25 personal-social (PS), 29 fine motor (FM), 39 language (LA) and 32 gross motor (GM). These test items are administered using a bell, glass bottle, set of 10 blocks, rattle, pencil, tennis ball, yarn, raisins, cup, white doll, white paper, and baby bottle. A child's raw score on each test item is marked as tested pass, failure, refusal, or no opportunity. The result of the test is labeled as &quot;normal,&quot; &quot;suspect&quot; or &quot;abnormal&quot;. Normal development means that there is no delay or at the maximum one warning. Abnormal development means that there is one or more than one delay situation. Suspicious development means that it is a situation involving one delay, one delay and one warning or two or more than two warnings. The number of children with normal, suspect or abnormal development is calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of diabetes mellitus in women</measure>
    <time_frame>6 weeks after delivery and 3 years after delivery</time_frame>
    <description>Measured by health professionals in clinic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of hypertension in women</measure>
    <time_frame>6 weeks after delivery and 3 years after delivery</time_frame>
    <description>Measured by health professionals in clinic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of child overweight and obesity</measure>
    <time_frame>Age at 6 weeks, 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years</time_frame>
    <description>Measured by health professionals in clinic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of children with warning signs</measure>
    <time_frame>Age at 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years</time_frame>
    <description>Measured by warning signs screening</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal Biparietal Diameter</measure>
    <time_frame>At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.</time_frame>
    <description>Measured by health professionals in clinic with ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal Head Circumference</measure>
    <time_frame>At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.</time_frame>
    <description>Measured by health professionals in clinic with ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal Abdominal Circumference</measure>
    <time_frame>At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.</time_frame>
    <description>Measured by health professionals in clinic with ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal Femur Length</measure>
    <time_frame>At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.</time_frame>
    <description>Measured by health professionals in clinic with ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal Humerus Length</measure>
    <time_frame>At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.</time_frame>
    <description>Measured by health professionals in clinic with ultrasound</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">5426</enrollment>
  <condition>Health Problems in Pregnancy</condition>
  <condition>Pregnancy Outcomes</condition>
  <condition>Gestational Diabetes</condition>
  <condition>Gestational Hypertension</condition>
  <condition>Preterm Birth</condition>
  <condition>Obesity</condition>
  <condition>Mother-Infant Interaction</condition>
  <condition>Child Development</condition>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Exposure group</arm_group_label>
    <description>Group with environmental, nutritional or lifestyle exposures</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-exposed group</arm_group_label>
    <description>Group without any environmental, nutritional and lifestyle exposures</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>This is an observational study without any intervention</description>
    <arm_group_label>Exposure group</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      During pregnancy: maternal blood. At delivery: cord blood，umbilical cord and placenta. During&#xD;
      childhood: blood.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women and their children in Tongzhou, China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pregnant women, &lt;14 gestational weeks&#xD;
&#xD;
          2. Resided in Tongzhou in the past half years and have no plan to move out after delivery&#xD;
&#xD;
          3. Pregnant women who plan to have antenatal care and delivery in Tongzhou maternal&amp;Child&#xD;
             Hospital.&#xD;
&#xD;
          4. Pregnant women who is willing to participate in this study with informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pregnant women have chronic disease before pregnancy, including diabetes，hypertension,&#xD;
        liver disease and kidney disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haijun Wang, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>March 11, 2021</last_update_submitted>
  <last_update_submitted_qc>March 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Hai-Jun Wang</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Hypertension, Pregnancy-Induced</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03814395
org study id: NNSF81703240
secondary id: 81703240
nct id: NCT03814395
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The PKUBC-T is a prospective cohort study carried out in Tongzhou district of Beijing, China.
      The primary aim of this study is to investigate the short-term and long-term effects of
      pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding
      environmental, nutritional and lifestyle exposures as well as short-term and long-term health
      outcomes of mothers and their children from birth to 6 years old. Biological samples
      including blood and tissue samples are also collected from mothers and their children.
Maternal and child health is of great concern globally. Early life phase of a fetus and
      infant is a critical period for the development of health and disease in the whole life.
      Exposure of negative environmental, nutritional and lifestyle factors in pregnant women
      during this period can have adverse effects on fetal and infant. In addition, for mothers,
      complications during pregnancy could also have a negative effect on long-term health of
      mothers, such as diabetes, hypertension. Thus, the Peking University Birth Cohort in Tongzhou
      is primarily aimed to investigate the short-term and long-term effects of pre-pregnant and
      prenatal exposure on maternal and child health. Data are collected regarding environmental,
      nutritional and lifestyle exposures as well as short-term and long-term health outcomes of
      mothers and their children from birth to 6 years old. Biological samples including blood and
      tissue samples are also collected from mothers and their children.
observational model: Cohort
time perspective: Prospective
measure: Numbers of participants with pregnancy complications
time frame: At delivery
description: Including gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy
measure: Numbers of participants with adverse pregnancy outcomes
time frame: At delivery
description: Including preterm birth, low birth weight, macrosomia, abortion, stillbirth, and birth defects.
measure: Weight in kilogram changes during childhood
time frame: At birth and age at 6 weeks, 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years
description: Measured by health professionals in clinic
measure: Height in centimeter changes during childhood
time frame: At birth and age at 6 weeks, 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years
description: Measured by health professionals in clinic
measure: Early Child development 1
time frame: Age at 6 weeks and 3 years
description: Measured by Ages&Stages Questionnaires (ASQ).There are 6 questions in each of 5 domains of development: communication, gross motor, fine motor, problem-solving skills, and adaptive skills. Each question is given a 10 (yes), 5 (sometimes), or 0 (not yet) score according to the parents' answers. The sum scores (range from 0 to 300) and scores for each domain (range from 0 to 60) are calculated. Chinese norms are available for each domain, and any domain screened <2 SDs below the mean is considered a positive screening. A higher ASQ score means better development.
measure: Early Child development 2
time frame: Age at 8-12 months
description: Measured by Denver Developmental Screening Test (DDST). DDST comprises 125 test items grouped into four domains of child development: 25 personal-social (PS), 29 fine motor (FM), 39 language (LA) and 32 gross motor (GM). These test items are administered using a bell, glass bottle, set of 10 blocks, rattle, pencil, tennis ball, yarn, raisins, cup, white doll, white paper, and baby bottle. A child's raw score on each test item is marked as tested pass, failure, refusal, or no opportunity. The result of the test is labeled as "normal," "suspect" or "abnormal". Normal development means that there is no delay or at the maximum one warning. Abnormal development means that there is one or more than one delay situation. Suspicious development means that it is a situation involving one delay, one delay and one warning or two or more than two warnings. The number of children with normal, suspect or abnormal development is calculated.
measure: Incidence of diabetes mellitus in women
time frame: 6 weeks after delivery and 3 years after delivery
description: Measured by health professionals in clinic
measure: Incidence of hypertension in women
time frame: 6 weeks after delivery and 3 years after delivery
description: Measured by health professionals in clinic
measure: Incidence of child overweight and obesity
time frame: Age at 6 weeks, 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years
description: Measured by health professionals in clinic
measure: The proportion of children with warning signs
time frame: Age at 3 months, 6 months, 8 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years, 5 years and 6 years
description: Measured by warning signs screening
measure: Fetal Biparietal Diameter
time frame: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
description: Measured by health professionals in clinic with ultrasound
measure: Fetal Head Circumference
time frame: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
description: Measured by health professionals in clinic with ultrasound
measure: Fetal Abdominal Circumference
time frame: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
description: Measured by health professionals in clinic with ultrasound
measure: Fetal Femur Length
time frame: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
description: Measured by health professionals in clinic with ultrasound
measure: Fetal Humerus Length
time frame: At 20-24 gestational week, 30-32 gestational week and 37-41 gestational week.
description: Measured by health professionals in clinic with ultrasound
arm group label: Exposure group
description: Group with environmental, nutritional or lifestyle exposures
arm group label: Non-exposed group
description: Group without any environmental, nutritional and lifestyle exposures
intervention type: Other
intervention name: No intervention
description: This is an observational study without any intervention
arm group label: Exposure group
During pregnancy: maternal blood. At delivery: cord blood，umbilical cord and placenta. During
      childhood: blood.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Haijun Wang, Ph.D
role: Principal Investigator
affiliation: Peking University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Hai-Jun Wang
investigator title: Prof.
mesh term: Diabetes, Gestational
mesh term: Premature Birth
mesh term: Hypertension, Pregnancy-Induced
sharing ipd: No