Effects of C-section Delivery on Infant Brain Development

Terminated

• Conditions: Healthy

• Registration Number: NCT03277612
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-11
• Study Start: 2017-09-22
• Primary Completion: 2019-03-25
• Study Completion: 2019-03-27
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 9

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Arkansas Children's Nutrition Center; 🇺🇸 Little Rock, Arkansas, United States