Healthy Clinical Trial
Official title:
Effects of C-section Delivery on Infant Brain Development
NCT number | NCT03277612 |
Other study ID # | 206515 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | September 22, 2017 |
Est. completion date | March 27, 2019 |
Verified date | December 2023 |
Source | Arkansas Children's Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study will help investigators learn more about whether different delivery modes influence infant's brain development
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. |
Country | Name | City | State |
---|---|---|---|
United States | Arkansas Children's Nutrition Center | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
Arkansas Children's Hospital Research Institute |
United States,
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 |
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