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Effects of C-section Delivery on Infant Brain Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03277612
Recruitment Status : Terminated (Study halted prematurely and will not resume; participants are no longer being examined)
First Posted : September 11, 2017
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

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

Condition or disease
Healthy

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.

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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 : September 22, 2017
Actual Primary Completion Date : March 25, 2019
Actual Study Completion Date : March 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Group/Cohort
C-Section
Infants delivered by C-section
Vaginal Delivery
Infants delivered by spontaneous vaginal delivery after C-section.



Primary Outcome Measures :
  1. Gut Microbiome and how it effects Brain Structure [ Time Frame: 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 [ Time Frame: 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


Biospecimen Retention:   Samples Without DNA
Blood, urine, stool, vaginal swabs, and breast milk samples will be collected.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy women and their unborn child
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277612


Locations
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United States, Arkansas
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
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Principal Investigator: Xiawei Ou, PhD Arkansas Children's Nutrition Center
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Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03277612    
Other Study ID Numbers: 206515
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No