<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/NCT03830879</url>
  </required_header>
  <id_info>
    <org_study_id>SZBCS</org_study_id>
    <nct_id>NCT03830879</nct_id>
  </id_info>
  <brief_title>Shenzhen Birth Cohort Study</brief_title>
  <official_title>Shenzhen Birth Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>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>
      The Shenzhen Birth Cohort Study was set up to investigate the effect of early life&#xD;
      environmental exposures on short- and long-term health consequences in Shenzhen, China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Shenzhen Birth Cohort (Xinmiao Project) is a scientific research/public health project under&#xD;
      the support of Shenzhen city and Nanshan district, which was jointly initiated by Nanshan&#xD;
      Maternity and Child Healthcare Hospital of Shenzhen and school of public health, Sun Yat-sen&#xD;
      University. The project plans to recruit 10,000 participants in early pregnancy and follow up&#xD;
      for seven years in the first stage. Biological samples, questionnaires and data for child&#xD;
      growth and development, disease and health will be collected. The study is aimed to provide&#xD;
      evidence for DOHaD Hypothesis and find the prevention and control measures for some childhood&#xD;
      diseases. The core members of the research team are composed of experts from different&#xD;
      disciplines in the field of public health, including 4 professors and 3 associate professors.&#xD;
      With the support of an executive sponsor, the project is undertaken by the Birth Cohort Study&#xD;
      Center. Currently, the center has 3 staff form hospital (one doctor and two masters ) and 5-7&#xD;
      master candidates from Sun Yat-sen University. It is an energetic and enthusiastic team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 6, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2032</completion_date>
  <primary_completion_date type="Anticipated">March 5, 2025</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>Fetal outcomes.</measure>
    <time_frame>At delivery.</time_frame>
    <description>Including intrauterine growth retardation, abortion, stillbirth, live birth, preterm. birth, low birth weight, macrosomia and birth defects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal weight changes (kg).</measure>
    <time_frame>At pre-pregnancy period, 20 weeks of gestation, 28 weeks of gestation, the time before labor and 30 days after delivery.</time_frame>
    <description>Assess using electronic weighing machine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participant with gestational complications.</measure>
    <time_frame>At delivery.</time_frame>
    <description>Including gestational hypertension and preeclampsia, and gestational diabetes mellitus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participant with postnatal depression.</measure>
    <time_frame>At 30 days after delivery, 3 months, 6 months after delivery.</time_frame>
    <description>Assess using Edinburgh Postnatal Depression Scale (EPDS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical development.</measure>
    <time_frame>at age of 1 month, 3 months, 6months, 1 year, 3 years and 6 years.</time_frame>
    <description>Including weight changes (kg) and height changes (cm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurodevelopment.</measure>
    <time_frame>at age of 1 month, 3 months, 6months, 1 year, 3 years and 5 years.</time_frame>
    <description>Including gross motor, fine motor, language, and social function, assess using Ages and Stages Questionnaires (ASQ-3 and ASQ-SE).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Pregnancy Complications</condition>
  <condition>Gestational Diabetes</condition>
  <condition>Obstetric Labor Complications</condition>
  <condition>Neurodevelopmental Disorders</condition>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
    <description>This cohort study have any no treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>This cohort study have any no intervention.</description>
    <arm_group_label>No treatment</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      During pregnancy: maternal blood, urine, hair and toenails. At delivery: umbilical cord&#xD;
      blood, placenta , umbilical cord, meconium, mother's saliva and milk. During infancy: dry&#xD;
      blood spot, stool and blood. During childhood: Mother's saliva, milk, baby's saliva and&#xD;
      feces.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women attending their first routine antenatal examinations and their partners and&#xD;
        offspring.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Pregnant women plan to delivery and participate in child care in our hospital; 2.&#xD;
             Pregnant women plan to reside in Shenzhen for at least 7 years; 3. Pregnant women who&#xD;
             show interest in the study and agree to provide informed consent; 4. Gestational weeks&#xD;
             are less than 20 weeks.Those who will agree that their neonatal will be included in&#xD;
             the study and be followed up regularly in our child health clinic until an age of 7&#xD;
             years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women who have been pregnant for more than 20 weeks; refuse to participate;&#xD;
             unable to guarantee delivery in our hospital or can't participate in child care in our&#xD;
             hospital; mentally incapacitated and need guardians; or be unwilling to sign informed&#xD;
             consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Li Cai</last_name>
    <phone>0086 20 87334956</phone>
    <email>caili5@mail.sysu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lihua Huang</last_name>
    <phone>0086 13570401256</phone>
    <email>hlihua2@mail2.sysu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>RuiGao</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rui Gao</last_name>
      <phone>86 13554809095</phone>
      <email>ruigao@szbcs.org</email>
    </contact>
    <investigator>
      <last_name>Weiqing Chen, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yuantao Hao, Professor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Li Cai</investigator_full_name>
    <investigator_title>Associate professor</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>Pregnancy Complications</mesh_term>
    <mesh_term>Obstetric Labor Complications</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
    <mesh_term>Neurodevelopmental Disorders</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/NCT03830879
org study id: SZBCS
nct id: NCT03830879
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Shenzhen Birth Cohort Study was set up to investigate the effect of early life
      environmental exposures on short- and long-term health consequences in Shenzhen, China.
Shenzhen Birth Cohort (Xinmiao Project) is a scientific research/public health project under
      the support of Shenzhen city and Nanshan district, which was jointly initiated by Nanshan
      Maternity and Child Healthcare Hospital of Shenzhen and school of public health, Sun Yat-sen
      University. The project plans to recruit 10,000 participants in early pregnancy and follow up
      for seven years in the first stage. Biological samples, questionnaires and data for child
      growth and development, disease and health will be collected. The study is aimed to provide
      evidence for DOHaD Hypothesis and find the prevention and control measures for some childhood
      diseases. The core members of the research team are composed of experts from different
      disciplines in the field of public health, including 4 professors and 3 associate professors.
      With the support of an executive sponsor, the project is undertaken by the Birth Cohort Study
      Center. Currently, the center has 3 staff form hospital (one doctor and two masters ) and 5-7
      master candidates from Sun Yat-sen University. It is an energetic and enthusiastic team.
observational model: Cohort
time perspective: Prospective
measure: Fetal outcomes.
time frame: At delivery.
description: Including intrauterine growth retardation, abortion, stillbirth, live birth, preterm. birth, low birth weight, macrosomia and birth defects.
measure: Maternal weight changes (kg).
time frame: At pre-pregnancy period, 20 weeks of gestation, 28 weeks of gestation, the time before labor and 30 days after delivery.
description: Assess using electronic weighing machine.
measure: Number of participant with gestational complications.
time frame: At delivery.
description: Including gestational hypertension and preeclampsia, and gestational diabetes mellitus.
measure: Number of participant with postnatal depression.
time frame: At 30 days after delivery, 3 months, 6 months after delivery.
description: Assess using Edinburgh Postnatal Depression Scale (EPDS).
measure: Physical development.
time frame: at age of 1 month, 3 months, 6months, 1 year, 3 years and 6 years.
description: Including weight changes (kg) and height changes (cm).
measure: Neurodevelopment.
time frame: at age of 1 month, 3 months, 6months, 1 year, 3 years and 5 years.
description: Including gross motor, fine motor, language, and social function, assess using Ages and Stages Questionnaires (ASQ-3 and ASQ-SE).
arm group label: No treatment
description: This cohort study have any no treatment.
intervention type: Other
intervention name: No intervention
description: This cohort study have any no intervention.
arm group label: No treatment
During pregnancy: maternal blood, urine, hair and toenails. At delivery: umbilical cord
      blood, placenta , umbilical cord, meconium, mother's saliva and milk. During infancy: dry
      blood spot, stool and blood. During childhood: Mother's saliva, milk, baby's saliva and
      feces.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Li Cai
phone: 0086 20 87334956
email: caili5@mail.sysu.edu.cn
last name: Lihua Huang
phone: 0086 13570401256
email: hlihua2@mail2.sysu.edu.cn
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Li Cai
investigator title: Associate professor
mesh term: Diabetes, Gestational
mesh term: Pregnancy Complications
mesh term: Obstetric Labor Complications
mesh term: Pediatric Obesity
mesh term: Neurodevelopmental Disorders
sharing ipd: Undecided