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Effects of C-section Delivery on Infant Brain Development

Sponsor
Arkansas Children's Hospital Research Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT03277612
Collaborator
(none)
9
Enrollment
1
Location
18.1
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will help investigators learn more about whether different delivery modes influence infant's brain development

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    9 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effects of C-section Delivery on Infant Brain Development
    Actual Study Start Date :
    Sep 22, 2017
    Actual Primary Completion Date :
    Mar 25, 2019
    Actual Study Completion Date :
    Mar 27, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    C-Section

    Infants delivered by C-section
    Vaginal Delivery

    Infants delivered by spontaneous vaginal delivery after C-section.

    Outcome Measures

    Primary Outcome Measures

    1. Gut Microbiome and how it effects Brain Structure [up to 2 weeks]

      Evaluate the relationship between gut microbiome and brain structural in infants based on mode of delivery as determined by an MRI

    2. Gut Microbiome and how it effects brain function [up to 2 weeks]

      Evaluate the relationship between gut microbiome and brain function in infants based on mode of delivery as determined by an MRI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Conceived without fertility treatments

    • Singleton pregnancy recruited at or before 36 weeks of gestation

    • Second parity with planned repeated C-section delivery or with planned spontaneous vaginal delivery after C-section.

    Exclusion Criteria:

    • Preexisting medical conditions

    • Sexually transmitted diseases

    • Medical complications developed during pregnancy

    • Medical complications developed during labor and delivery

    • Emergency c-section delivery

    • Infants born preterm or post-term

    • Infants needing mechanical ventilation, have congenital abnormalities, birth defects, intrauterine growth restriction, low Apgar score (<7), or other medical issues developed at birth or before 2 weeks of age affecting the outcome of interest as determined by the PI.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arkansas Children's Nutrition Center Little Rock Arkansas United States 72202

    Sponsors and Collaborators

    • Arkansas Children's Hospital Research Institute

    Investigators

    • Principal Investigator: Xiawei Ou, PhD, Arkansas Children's Nutrition Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arkansas Children's Hospital Research Institute
    ClinicalTrials.gov Identifier:
    NCT03277612
    Other Study ID Numbers:
    • 206515
    First Posted:
    Sep 11, 2017
    Last Update Posted:
    Sep 30, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 30, 2020