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RECRUITING
NCT03298334
PHASE1/PHASE2

Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.

Official title: Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

0 Days - 50 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2018-07-01

Completion Date

2029-04

Last Updated

2025-06-08

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Vaginal Seeding

A gauze containing the Mother's vaginal flora will be swabbed over the face and body of the neonate shortly after cesarean delivery.

OTHER

No Vaginal Seeding

A gauze carrying sterile saline will be swabbed over the face and body of the neonate shortly after cesarean delivery.

Locations (1)

Inova Health System

Falls Church, Virginia, United States