<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/NCT03809390</url>
  </required_header>
  <id_info>
    <org_study_id>NSFC.81701538</org_study_id>
    <nct_id>NCT03809390</nct_id>
  </id_info>
  <brief_title>Effects of Vaginal Seeding on Infants' Body Mass Index and Allergy Risk for Caesarean-delivered Children</brief_title>
  <official_title>Effects of Vaginal Seeding on Infants' Body Mass Index and Allergy Risk for Caesarean-delivered Children: A Randomized Controlled Study</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>
    <collaborator>
      <agency>Liuyang Maternal and Child Health Care Hospital</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>
      This is a single-blind randomized controlled trial, aiming to evaluate the effects of vaginal&#xD;
      seeding on body mass index as well as allergy risk for cesarean-delivered infants. It will be&#xD;
      conducted in Liuyang city of China, and the targeted sample size is 106. All the eligible&#xD;
      pregnant women will be randomly assigned to either the intervention or control group, and&#xD;
      their babies of the participants will be followed up to 24 months of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many studies have suggested that caesarean-delivered children are at higher risks of&#xD;
      developing metabolic and allergic diseases like obesity and asthma, possibly because newborns&#xD;
      born by caesarean section were lack of exposure to maternal vaginal flora. It is needed to&#xD;
      explore a simple, convenient, and safe intervention strategy to reduce caesarean-related&#xD;
      risks. In a recent non-randomized study, the authors found that exposure of&#xD;
      caesarean-delivered newborns to maternal vaginal fluid at birth (i.e., vaginal seeding) could&#xD;
      partially restore the microbiota of them at 30 days after births, but the long-term health&#xD;
      consequences of restoring the microbiota of caesarean-delivered infants remain unclear.&#xD;
&#xD;
      In this randomized study, the investigators aim to examine whether the changes in newborns'&#xD;
      microbiota will persist to 24 month of age, and whether vaginal seeding will have any effects&#xD;
      on body mass index and allergy risk from birth to 24 months of age. the investigators will&#xD;
      enroll a total of 106 pregnant women, and the participants' infants will be followed up at 0&#xD;
      (before hospital discharge), 6, 12, 18 and 24 months. At each follow-up visit, a&#xD;
      questionnaire survey including information on feeding, medication, and allergic status will&#xD;
      be conducted, infants' height and weight will be measured, and feces will be collected. At&#xD;
      18-month-old visit, infants' venous blood will be also collected for the assay of&#xD;
      multiallergen. The primary outcomes were body mass index and allergy risk index. The&#xD;
      secondary outcomes included the microbiota profile, allergic symptoms and diseases,&#xD;
      overweight/obesity, and adverse effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 17, 2018</start_date>
  <completion_date type="Anticipated">November 2022</completion_date>
  <primary_completion_date type="Actual">September 20, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>infant's body mass index</measure>
    <time_frame>At 6 months</time_frame>
    <description>Body mass index in original scale and z-score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>infant's body mass index</measure>
    <time_frame>At 12 months</time_frame>
    <description>Body mass index in original scale and z-score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>infant's body mass index</measure>
    <time_frame>At 18 months</time_frame>
    <description>Body mass index in original scale and z-score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>infant's body mass index</measure>
    <time_frame>At 24 months</time_frame>
    <description>Body mass index in original scale and z-score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>infant's allergy risk score</measure>
    <time_frame>At 18 months after birth</time_frame>
    <description>Calculated based on the measurements of multiallergens with 0-6 classes,higher values represent a worse outcome which means more susceptible to allergic diseases</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infants' gut microbiota profile</measure>
    <time_frame>At baseline (Meconium), 6, 12 ,18 and 24 months after birth</time_frame>
    <description>Intestinal flora will be detected by 16sRNA sequencing using feces samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of overweight/obesity</measure>
    <time_frame>At 6, 12 ,18 and 24months</time_frame>
    <description>Defined by body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of allergic symptoms and common allergic diseases</measure>
    <time_frame>At 61, 12 ,18 and 24 months</time_frame>
    <description>Collected by using a structured questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of adverse effects</measure>
    <time_frame>From birth to 24 months</time_frame>
    <description>Infection-related diseases and others</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">117</enrollment>
  <condition>Overweight and Obesity</condition>
  <condition>Allergy</condition>
  <arm_group>
    <arm_group_label>Vaginal seeding group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Swabbing infants born by C-section with a gauze incubated in the maternal vagina about an hour before the C-section. The gauze will be extracted prior to the C-section, kept in a sterile container in an incubator (37 ℃), and taken out from the incubator immediately before the swabbing. The infant will be swabbed with the gauze, starting from the lips, followed by the face, thorax, arms, legs, genitals and anal region, and finally the back. The swabbing will take around 15-20 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Managed based on the standard practice in the study site</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vaginal seeding</intervention_name>
    <description>The same as that stated in arm descriptions.</description>
    <arm_group_label>Vaginal seeding group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  local resident in Liuyang city&#xD;
&#xD;
          -  Singleton, term pregnancy (≥37 weeks of gestation)&#xD;
&#xD;
          -  Cesarean section before labor starts without maternal complications, or cesarean&#xD;
             section after the start of labor but the cervix is less than 3 cm&#xD;
&#xD;
          -  Vaginal pH&lt; 4.5 at enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive testing for HIV, HBV, syphilis or GBS infection at gestation&#xD;
&#xD;
          -  Vaginal infections such as genital herpetic lesions or chlamydia&#xD;
&#xD;
          -  Bacterial vaginosis&#xD;
&#xD;
          -  Trichomonas or fungous in leucorrhea&#xD;
&#xD;
          -  Pregnant women or her spouse with severe allergic diseases, such as asthma and severe&#xD;
             drug allergy&#xD;
&#xD;
          -  Vaginal pH ≥4.5 at 1-2 hours before the cesarean section&#xD;
&#xD;
          -  Other conditions not suitable for intervention as judged by obstetricians&#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>Jian-meng Liu, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hong-tian Li, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shujin Zhou, MD</last_name>
    <role>Study Director</role>
    <affiliation>Liuyang Maternal and Child Health Care Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yang Liu, PhD Candidate</last_name>
    <role>Study Director</role>
    <affiliation>Peking University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Liuyang Maternal and Child Health Care Hospital</name>
      <address>
        <city>Liuyang</city>
        <state>Hunan</state>
        <zip>410399</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 17, 2018</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>December 9, 2021</last_update_submitted>
  <last_update_submitted_qc>December 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Jianmeng Liu</investigator_full_name>
    <investigator_title>Professor in Perinatal Epidemiology</investigator_title>
  </responsible_party>
  <keyword>Body mass index</keyword>
  <keyword>Allergic risk</keyword>
  <keyword>Vaginal seeding</keyword>
  <keyword>Randomized controlled study</keyword>
  <keyword>Caesarean delivery</keyword>
  <keyword>Overweight and obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The IPD will be shared upon the request of other researchers, and all the key variables that will be reported in the main paper are planned to be shared</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>After the publication of the main paper (hopefully before the end of 2022), the data will be available to share to other researchers</ipd_time_frame>
    <ipd_access_criteria>Researchers should request the data via the following Email: lihongtian@pku.edu.cn or liujm@pku.edu.cn</ipd_access_criteria>
  </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/NCT03809390
org study id: NSFC.81701538
nct id: NCT03809390
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single-blind randomized controlled trial, aiming to evaluate the effects of vaginal
      seeding on body mass index as well as allergy risk for cesarean-delivered infants. It will be
      conducted in Liuyang city of China, and the targeted sample size is 106. All the eligible
      pregnant women will be randomly assigned to either the intervention or control group, and
      their babies of the participants will be followed up to 24 months of age.
Many studies have suggested that caesarean-delivered children are at higher risks of
      developing metabolic and allergic diseases like obesity and asthma, possibly because newborns
      born by caesarean section were lack of exposure to maternal vaginal flora. It is needed to
      explore a simple, convenient, and safe intervention strategy to reduce caesarean-related
      risks. In a recent non-randomized study, the authors found that exposure of
      caesarean-delivered newborns to maternal vaginal fluid at birth (i.e., vaginal seeding) could
      partially restore the microbiota of them at 30 days after births, but the long-term health
      consequences of restoring the microbiota of caesarean-delivered infants remain unclear.

      In this randomized study, the investigators aim to examine whether the changes in newborns'
      microbiota will persist to 24 month of age, and whether vaginal seeding will have any effects
      on body mass index and allergy risk from birth to 24 months of age. the investigators will
      enroll a total of 106 pregnant women, and the participants' infants will be followed up at 0
      (before hospital discharge), 6, 12, 18 and 24 months. At each follow-up visit, a
      questionnaire survey including information on feeding, medication, and allergic status will
      be conducted, infants' height and weight will be measured, and feces will be collected. At
      18-month-old visit, infants' venous blood will be also collected for the assay of
      multiallergen. The primary outcomes were body mass index and allergy risk index. The
      secondary outcomes included the microbiota profile, allergic symptoms and diseases,
      overweight/obesity, and adverse effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: infant's body mass index
time frame: At 6 months
description: Body mass index in original scale and z-score
measure: infant's body mass index
time frame: At 12 months
description: Body mass index in original scale and z-score
measure: infant's body mass index
time frame: At 18 months
description: Body mass index in original scale and z-score
measure: infant's body mass index
time frame: At 24 months
description: Body mass index in original scale and z-score
measure: infant's allergy risk score
time frame: At 18 months after birth
description: Calculated based on the measurements of multiallergens with 0-6 classes,higher values represent a worse outcome which means more susceptible to allergic diseases
measure: Infants' gut microbiota profile
time frame: At baseline (Meconium), 6, 12 ,18 and 24 months after birth
description: Intestinal flora will be detected by 16sRNA sequencing using feces samples
measure: Rate of overweight/obesity
time frame: At 6, 12 ,18 and 24months
description: Defined by body mass index
measure: Rate of allergic symptoms and common allergic diseases
time frame: At 61, 12 ,18 and 24 months
description: Collected by using a structured questionnaire
measure: Rate of adverse effects
time frame: From birth to 24 months
description: Infection-related diseases and others
arm group label: Vaginal seeding group
arm group type: Experimental
description: Swabbing infants born by C-section with a gauze incubated in the maternal vagina about an hour before the C-section. The gauze will be extracted prior to the C-section, kept in a sterile container in an incubator (37 ℃), and taken out from the incubator immediately before the swabbing. The infant will be swabbed with the gauze, starting from the lips, followed by the face, thorax, arms, legs, genitals and anal region, and finally the back. The swabbing will take around 15-20 seconds.
arm group label: Control group
arm group type: No Intervention
description: Managed based on the standard practice in the study site
intervention type: Procedure
intervention name: Vaginal seeding
description: The same as that stated in arm descriptions.
arm group label: Vaginal seeding group
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jian-meng Liu, PhD
role: Study Chair
affiliation: Peking University
last name: Hong-tian Li, PhD
role: Principal Investigator
affiliation: Peking University
last name: Shujin Zhou, MD
role: Study Director
affiliation: Liuyang Maternal and Child Health Care Hospital
last name: Yang Liu, PhD Candidate
role: Study Director
affiliation: Peking University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Jianmeng Liu
investigator title: Professor in Perinatal Epidemiology
mesh term: Overweight
mesh term: Hypersensitivity
sharing ipd: Yes
ipd description: The IPD will be shared upon the request of other researchers, and all the key variables that will be reported in the main paper are planned to be shared
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: After the publication of the main paper (hopefully before the end of 2022), the data will be available to share to other researchers
ipd access criteria: Researchers should request the data via the following Email: lihongtian@pku.edu.cn or liujm@pku.edu.cn