Effects of C-section Delivery on Infant Brain Development

Healthy Clinical Trial

Official title:

Effects of C-section Delivery on Infant Brain Development

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03277612
• Other study ID #: 206515
• Status: Terminated
• Start date: September 22, 2017
• Est. completion date: March 27, 2019

Study information

• Verified date: December 2023
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 27, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
United States	Arkansas Children's Nutrition Center	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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