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Effects of C-section Delivery on Infant Brain Development

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ClinicalTrials.gov Identifier: NCT03277612
Recruitment Status : Terminated (Study halted prematurely and will not resume; participants are no longer being examined)
First Posted : September 11, 2017
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

Tracking Information
First Submitted Date June 28, 2017
First Posted Date September 11, 2017
Last Update Posted Date September 30, 2020
Actual Study Start Date September 22, 2017
Actual Primary Completion Date March 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 7, 2017)
  • Gut Microbiome and how it effects Brain Structure [ Time Frame: 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 [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of C-section Delivery on Infant Brain Development
Official Title Effects of C-section Delivery on Infant Brain Development
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood, urine, stool, vaginal swabs, and breast milk samples will be collected.
Sampling Method Non-Probability Sample
Study Population Healthy women and their unborn child
Condition Healthy
Intervention Not Provided
Study Groups/Cohorts
  • C-Section
    Infants delivered by C-section
  • Vaginal Delivery
    Infants delivered by spontaneous vaginal delivery after C-section.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: October 7, 2019)
9
Original Estimated Enrollment
 (submitted: September 7, 2017)
70
Actual Study Completion Date March 27, 2019
Actual Primary Completion Date March 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03277612
Other Study ID Numbers 206515
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Arkansas Children's Hospital Research Institute
Study Sponsor Arkansas Children's Hospital Research Institute
Collaborators Not Provided
Investigators
Principal Investigator: Xiawei Ou, PhD Arkansas Children's Nutrition Center
PRS Account Arkansas Children's Hospital Research Institute
Verification Date September 2020