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.
Scheduled for cesarean delivery at ≥ 37 weeks
Pregnant with single fetus, in good general health, age 18 years or older
Negative maternal testing for infections transmitted through vaginal and/or other body fluids performed as standard of care tests in early pregnancy
Negative testing for Group B strep at 35-37 weeks gestation
Delivery at a hospital other than Inova Health System
Cesarean delivery scheduled for active infection that would have interfered with vaginal delivery such as genital herpetic lesions
Rupture of membranes prior to scheduled cesarean delivery
Bacterial vaginosis within 30 days of cesarean delivery
Parallel
Vaginal Seeding
Biological/VaccineA gauze containing the Mother's vaginal flora will be swabbed over the face and body of the neonate shortly after cesarean delivery.
No Vaginal Seeding
Other interventionA gauze carrying sterile saline will be swabbed over the face and body of the neonate shortly after cesarean delivery.
Adiposity
E.g. Body mass index z-score
Adverse events
Monitoring for adverse events
Intestinal microbiota
Intestinal microbiota development over the first three years of life
Immune and inflammatory regulation
E.g. Monitoring for immune and inflammatory mediated conditions
Click on the lead sponsor to view all of their trials.
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Johns Hopkins University
Collaborator
Rutgers University
Collaborator
Inova Health Care Services
Collaborator
