<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/NCT03277612</url>
  </required_header>
  <id_info>
    <org_study_id>206515</org_study_id>
    <nct_id>NCT03277612</nct_id>
  </id_info>
  <brief_title>Effects of C-section Delivery on Infant Brain Development</brief_title>
  <official_title>Effects of C-section Delivery on Infant Brain Development</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arkansas Children's Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arkansas Children's Hospital Research Institute</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 study will help investigators learn more about whether different delivery modes influence&#xD;
      infant's brain development&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For this study, the investigators are enrolling women who are pregnant with their second&#xD;
      child who are planning to have a planned C-section or a spontaneous vaginal birth after&#xD;
      C-section. The investigators will see the pregnant mom at 36 weeks pregnant and then have the&#xD;
      mom and the baby return for a visit at 2 weeks postnatal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study halted prematurely and will not resume; participants are no longer being examined&#xD;
  </why_stopped>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Actual">March 27, 2019</completion_date>
  <primary_completion_date type="Actual">March 25, 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>Gut Microbiome and how it effects Brain Structure</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>Evaluate the relationship between gut microbiome and brain structural in infants based on mode of delivery as determined by an MRI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gut Microbiome and how it effects brain function</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>Evaluate the relationship between gut microbiome and brain function in infants based on mode of delivery as determined by an MRI</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">9</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>C-Section</arm_group_label>
    <description>Infants delivered by C-section</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaginal Delivery</arm_group_label>
    <description>Infants delivered by spontaneous vaginal delivery after C-section.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, urine, stool, vaginal swabs, and breast milk samples will be collected.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy women and their unborn child&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Conceived without fertility treatments&#xD;
&#xD;
          -  Singleton pregnancy recruited at or before 36 weeks of gestation&#xD;
&#xD;
          -  Second parity with planned repeated C-section delivery or with planned spontaneous&#xD;
             vaginal delivery after C-section.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preexisting medical conditions&#xD;
&#xD;
          -  Sexually transmitted diseases&#xD;
&#xD;
          -  Medical complications developed during pregnancy&#xD;
&#xD;
          -  Medical complications developed during labor and delivery&#xD;
&#xD;
          -  Emergency c-section delivery&#xD;
&#xD;
          -  Infants born preterm or post-term&#xD;
&#xD;
          -  Infants needing mechanical ventilation, have congenital abnormalities, birth defects,&#xD;
             intrauterine growth restriction, low Apgar score (&lt;7), or other medical issues&#xD;
             developed at birth or before 2 weeks of age affecting the outcome of interest as&#xD;
             determined by the PI.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiawei Ou, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Arkansas Children's Nutrition Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arkansas Children's Nutrition Center</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>March 26, 2023</last_update_submitted>
  <last_update_submitted_qc>March 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03277612
org study id: 206515
nct id: NCT03277612
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study will help investigators learn more about whether different delivery modes influence
      infant's brain development
For this study, the investigators are enrolling women who are pregnant with their second
      child who are planning to have a planned C-section or a spontaneous vaginal birth after
      C-section. The investigators will see the pregnant mom at 36 weeks pregnant and then have the
      mom and the baby return for a visit at 2 weeks postnatal.
observational model: Cohort
time perspective: Prospective
measure: Gut Microbiome and how it effects Brain Structure
time frame: up to 2 weeks
description: Evaluate the relationship between gut microbiome and brain structural in infants based on mode of delivery as determined by an MRI
measure: Gut Microbiome and how it effects brain function
time frame: up to 2 weeks
description: Evaluate the relationship between gut microbiome and brain function in infants based on mode of delivery as determined by an MRI
arm group label: C-Section
description: Infants delivered by C-section
arm group label: Vaginal Delivery
description: Infants delivered by spontaneous vaginal delivery after C-section.
Blood, urine, stool, vaginal swabs, and breast milk samples will be collected.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Xiawei Ou, PhD
role: Principal Investigator
affiliation: Arkansas Children's Nutrition Center
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No