Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates: a Randomized Controlled Trial
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
• Vaginal pH ≤ 4.5 indicative of Lactobacillus-dominated vaginal microbiota
• No maternal or fetal complications that may inhibit the ability to perform microbiome restoration per protocol
• English or Spanish speaking
• Negative maternal testing for Gonorrhea, Chlamydia, Hepatitis B, Hepatitis C, Syphilis, and HIV at 35 weeks gestation or later
• Women aged 18-29 years must have a normal Pap test within 3 years
• Women aged 30-65 years must have a normal Pap test and an HPV test (co-testing) within 5 years or FDA-approved primary hrHPV testing alone within 5 years or a normal Pap test alone within 3 years
• Negative maternal testing for SARS-CoV-2 for the delivery admission performed as standard of care test at the Inova Health System.
• Infant condition after delivery requires no more than standard neonatal resuscitation\* or is otherwise medically unable to receive the full VMT procedure
⁃ \[\*\] Standard neonatal resuscitation may include: tactile stimulation, bulb suction, oxygen without positive pressure, or drying