Effects of C-section Delivery on Infant Brain Development

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03277612

Enrollment

Registered

2017-09-11

Start date

2017-09-22

Completion date

2019-03-27

Last updated

2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Gut Microbiome and how it effects Brain Structure	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	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

Countries

United States

Outcome results