NCT03277612

Terminated

Effects of C-section Delivery on Infant Brain Development

Arkansas Children's Hospital Research Institute Source

Arkansas Children's Hospital Research Institute

ClinicalTrials.gov

Compare

Other study identifiers

Sponsor study identifier

206515

Study Type

observational

Actual enrollment (reported)

9

Locations

1 country

Sites

1

Timeline

Study Start

September 22, 2017

Actual (reported)

Primary Completion

March 25, 2019

Actual (reported)

Study Completion

March 27, 2019

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 9 participants
Study completion date: March 27, 2019
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 28, 2017
Actual (reported)
First Posted
September 11, 2017
Actual (reported)
Study Start
September 22, 2017
Actual (reported)
Primary Completion
March 25, 2019
Actual (reported)
Study Completion
March 27, 2019
Actual (reported)

Last Updated: December 20, 2023
Status Verified: December 2023
Last Update Submitted: December 18, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

Study Arms (2)

C-Section

Infants delivered by C-section

Vaginal Delivery

Infants delivered by spontaneous vaginal delivery after C-section.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Healthy women and their unborn child

You may qualify if:

Conceived without fertility treatments

Sponsors & Collaborators

Arkansas Children's Hospital Research Institute
Otherlead

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine, stool, vaginal swabs, and breast milk samples will be collected.

Study Officials

Xiawei Ou, PhD
Arkansas Children's Nutrition Center
PRINCIPAL INVESTIGATOR

Enrollment

9 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 28, 2017

First Posted

September 11, 2017

Study Start

September 22, 2017

Actual (reported)

Completed

NCT03614312

Placenta Development Study

Completed

NCT04274140

Maternal Obesity and Offspring Neurodevelopment

Active Not Recruiting

NCT02676960

Feasibility Study: MRI on 6 Months, 1 Year, and 2 Years Old Children Without Sedation

Completed

NCT04470505

Optimizing Platelet Isolation (The Cell Study)

Completed

NCT02536846

The Effects of Antipsychotic Drugs on Brain Metabolism in Healthy Individuals

Phase 4Completed

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Primary Completion

March 25, 2019

Actual (reported)

Study Completion

March 27, 2019

Actual (reported)

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03277612
Data provider: ClinicalTrials.gov
Source updated: 2023-12-20
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:37:54 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

C-Section

Vaginal Delivery

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations