Effects of C-section Delivery on Infant Brain Development

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

Study Overview

• Status: Terminated
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Nutrition Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy women and their unborn child

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut Microbiome and how it effects Brain Structure	Evaluate the relationship between gut microbiome and brain structural in infants based on mode of delivery as determined by an MRI	up to 2 weeks
Gut Microbiome and how it effects brain function	Evaluate the relationship between gut microbiome and brain function in infants based on mode of delivery as determined by an MRI	up to 2 weeks

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute
• Investigators: Principal Investigator: Xiawei Ou, PhD, Arkansas Children's Nutrition Center

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2017
• Primary Completion (Actual): March 25, 2019
• Study Completion (Actual): March 27, 2019

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 206515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No