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Effects of C-section Delivery on Infant Brain Development

NCT ID: NCT03277612

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-22

Study Completion Date

2019-03-27

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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C-Section

Infants delivered by C-section

No interventions assigned to this group

Vaginal Delivery

Infants delivered by spontaneous vaginal delivery after C-section.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiawei Ou, PhD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Children's Nutrition Center

Locations

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Arkansas Children's Nutrition Center

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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206515

Identifier Type: -

Identifier Source: org_study_id