HealthyNCT03277612
Effects of C-section Delivery on Infant Brain Development
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
The study will help investigators learn more about whether different delivery modes influence infant's brain development Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2017to 27 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy women and their unborn child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
The study will help investigators learn more about whether different delivery modes influence infant's brain development
Read the 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.
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| C-Section | Infants delivered by C-section | |
| Vaginal Delivery | Infants delivered by spontaneous vaginal delivery after C-section. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start22 Sep 2017
- Primary completion25 Mar 2019
- Study completion27 Mar 2019
Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiawei Ou, PhD, Principal investigator, Arkansas Children's Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277612
- Sponsor's protocol ID
- 206515
- Status last verified
- Dec 2023
- First submitted
- 28 Jun 2017
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of C-section Delivery on Infant Brain Development
- ClinicalTrials.gov ID
- NCT03277612
- Acronym / sponsor ID
- 206515
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume; participants are no longer being examined
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-Section | – | –Infants delivered by C-section |
| Vaginal Delivery | – | –Infants delivered by spontaneous vaginal delivery after C-section. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy women and their unborn child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Preexisting medical conditions
- Sexually transmitted diseases
- Medical complications developed during pregnancy
- Medical complications developed during labor and delivery
- Emergency c-section delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: Study halted prematurely and will not resume; participants are no longer being examined). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiawei Ou, PhD principal investigator
Arkansas Children's Nutrition Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study halted prematurely and will not resume; participants are no longer being examined). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiome and how it effects Brain Structure (time frame: up to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.