<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/NCT04499066</url>
  </required_header>
  <id_info>
    <org_study_id>2018053101</org_study_id>
    <nct_id>NCT04499066</nct_id>
  </id_info>
  <brief_title>Peripartum Mental Health Cohort Study in Guangzhou</brief_title>
  <official_title>Peripartum Mental Health Cohort Study in Guangzhou</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou Women and Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou Women and Children's Medical Center</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 purpose of this study is to determine the incidence,development trajectory and risk&#xD;
      factors of the main peripartum mental health problems as well as explore its adverse&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peripartum mental health problems (such as anxiety and depression), affecting more than 20%&#xD;
      of mothers, is one of the most common complications around childbirth and gradually have&#xD;
      become global public health issues. However, little is known about the course of peripartum&#xD;
      mental health problems and possible fluctuations, as well as related risk factors among&#xD;
      Chinese women. In addition, there are no effective prediction and preventive strategies for&#xD;
      postpartum depression. The Peripartum Mental Health Cohort Study in Guangzhou will collect&#xD;
      the epidemiological, clinical information and biological specimens across pregnancy and&#xD;
      childbirth to establish trajectory of peripartum mental health and identify the factors&#xD;
      influencing the fluctuations and build a comprehensive prediction model of postpartum&#xD;
      depression, as well as explore its adverse outcomes. This study would help to determine the&#xD;
      timing of screening and target interventions to improve women's and their offspring's health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2012</start_date>
  <completion_date type="Anticipated">December 31, 2038</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Change of prevalence of maternal prenatal depression</measure>
    <time_frame>before 20th gestational week, after 33th gestational week and prior to delivery</time_frame>
    <description>Using Self-rating Depression Scale (SDS) to assess maternal depressive symptoms during pregnancy. SDS scores ≥53 is defined as prenatal depressive symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of prevalence of maternal postpartum depression in the first year after delivery</measure>
    <time_frame>6 weeks, 6 months and 1 year after delivery</time_frame>
    <description>Using Edinburgh Postnatal Depression Scale (EPDS) to assess postpartum depressive symptoms. EPDS scores ≥13 is defined as postpartum depressive symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of prevalence of maternal anxiety during pregnancy</measure>
    <time_frame>before 20th gestational week, after 33th gestational week and prior to delivery</time_frame>
    <description>Using Self-rating Anxiety Scale (SAS) to assess maternal anxiety during pregnancy. SAS scores ≥50 is defined as anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of maternal cortisol during pregnancy</measure>
    <time_frame>During period of 2-3 trimesters of pregnancy</time_frame>
    <description>Using women's blood samples to test the concentration of cortisol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of maternal inflammatory factors during pregnancy</measure>
    <time_frame>During period of 2-3 trimesters of pregnancy</time_frame>
    <description>Using women's blood samples to test the concentration of inflammatory factors, including CRP, IL-6, TNF-α, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of preterm birth, small for gestational age, low birth weight</measure>
    <time_frame>At delivery</time_frame>
    <description>Obtained from electronic medical records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child's neurodevelopment at early childhood</measure>
    <time_frame>At child's age of 1 year</time_frame>
    <description>Assessed by using the Gesell Developmental Schedules, which includes adaptive, gross motor, fine motor, language, and social function domains. Higher score in each domain is considered a better outcome, while no more than 85 is defined as suspected development delay.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      During pregnancy: maternal blood, urine and stool. At delivery: cord, cord blood and&#xD;
      placenta. During infancy: dry blood spot and blood of children.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women before 20 weeks of gestation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pregnant women with &lt;20 weeks of gestation&#xD;
&#xD;
          2. Pregnant women intended to eventually deliver in Guangzhou Women and Children's&#xD;
             Medical Center&#xD;
&#xD;
          3. Permanent residents or families intended to remain in Guangzhou with their child for&#xD;
             more than 3 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Combined with heart disease, hypertension, diabetes or hyperthyroidism&#xD;
&#xD;
          2. Taking anti-depressants and other treatments for depression&#xD;
&#xD;
          3. Participants was in infection status when the biological samples were collected&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiu Qiu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangzhou Women and Children's Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiu Qiu, PhD</last_name>
    <phone>0086 20 38367160</phone>
    <email>qxiu0161@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dongmei Wei, MSc</last_name>
    <phone>0086 20 38367159</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Guangzhou Women and Children's Medical Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510623</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiu Qiu, PhD</last_name>
      <email>qxiu0161@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20.</citation>
    <PMID>28321694</PMID>
  </reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou Women and Children's Medical Center</investigator_affiliation>
    <investigator_full_name>Xiu Qiu</investigator_full_name>
    <investigator_title>Director of the Born in Guangzhou Cohort Study</investigator_title>
  </responsible_party>
  <keyword>Peripartum</keyword>
  <keyword>Mental health</keyword>
  <keyword>Risk factors</keyword>
  <keyword>Pregnancy outcome</keyword>
  <keyword>Cohort</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT04499066
org study id: 2018053101
nct id: NCT04499066
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the incidence,development trajectory and risk
      factors of the main peripartum mental health problems as well as explore its adverse
      outcomes.
Peripartum mental health problems (such as anxiety and depression), affecting more than 20%
      of mothers, is one of the most common complications around childbirth and gradually have
      become global public health issues. However, little is known about the course of peripartum
      mental health problems and possible fluctuations, as well as related risk factors among
      Chinese women. In addition, there are no effective prediction and preventive strategies for
      postpartum depression. The Peripartum Mental Health Cohort Study in Guangzhou will collect
      the epidemiological, clinical information and biological specimens across pregnancy and
      childbirth to establish trajectory of peripartum mental health and identify the factors
      influencing the fluctuations and build a comprehensive prediction model of postpartum
      depression, as well as explore its adverse outcomes. This study would help to determine the
      timing of screening and target interventions to improve women's and their offspring's health.
observational model: Cohort
time perspective: Prospective
measure: Change of prevalence of maternal prenatal depression
time frame: before 20th gestational week, after 33th gestational week and prior to delivery
description: Using Self-rating Depression Scale (SDS) to assess maternal depressive symptoms during pregnancy. SDS scores ≥53 is defined as prenatal depressive symptoms.
measure: Change of prevalence of maternal postpartum depression in the first year after delivery
time frame: 6 weeks, 6 months and 1 year after delivery
description: Using Edinburgh Postnatal Depression Scale (EPDS) to assess postpartum depressive symptoms. EPDS scores ≥13 is defined as postpartum depressive symptoms.
measure: Change of prevalence of maternal anxiety during pregnancy
time frame: before 20th gestational week, after 33th gestational week and prior to delivery
description: Using Self-rating Anxiety Scale (SAS) to assess maternal anxiety during pregnancy. SAS scores ≥50 is defined as anxiety.
measure: Level of maternal cortisol during pregnancy
time frame: During period of 2-3 trimesters of pregnancy
description: Using women's blood samples to test the concentration of cortisol.
measure: Levels of maternal inflammatory factors during pregnancy
time frame: During period of 2-3 trimesters of pregnancy
description: Using women's blood samples to test the concentration of inflammatory factors, including CRP, IL-6, TNF-α, etc.
measure: Prevalence of preterm birth, small for gestational age, low birth weight
time frame: At delivery
description: Obtained from electronic medical records.
measure: Child's neurodevelopment at early childhood
time frame: At child's age of 1 year
description: Assessed by using the Gesell Developmental Schedules, which includes adaptive, gross motor, fine motor, language, and social function domains. Higher score in each domain is considered a better outcome, while no more than 85 is defined as suspected development delay.
During pregnancy: maternal blood, urine and stool. At delivery: cord, cord blood and
      placenta. During infancy: dry blood spot and blood of children.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Xiu Qiu, PhD
role: Principal Investigator
affiliation: Guangzhou Women and Children's Medical Center
last name: Xiu Qiu, PhD
phone: 0086 20 38367160
email: qxiu0161@163.com
last name: Dongmei Wei, MSc
phone: 0086 20 38367159
facility: 
status: Recruiting
contact: 
country: China
citation: Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20.
PMID: 28321694
responsible party type: Principal Investigator
investigator affiliation: Guangzhou Women and Children's Medical Center
investigator full name: Xiu Qiu
investigator title: Director of the Born in Guangzhou Cohort Study
mesh term: Depression
sharing ipd: No