NCT03277612

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

September 22, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2019

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

June 28, 2017

Last Update Submit

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
  • 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.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

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

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

Primary Completion

March 25, 2019

Study Completion

March 27, 2019

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)