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

Inclusion Criteria for Mother

• 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.

Inclusion Criteria for Infant

• 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

Exclusion Criteria for Mother

• 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
• Symptomatic urinary tract infection within 30 days of cesarean delivery
• Antibiotic therapy within 30 days of cesarean delivery (exclusive of medication use for prophylaxis at the time of surgery)
• Symptoms on admission suggesting Chorioamnionitis, e.g. maternal fever, fundal tenderness
• Symptoms on delivery admission of possible vaginal infection such as genital herpetic lesions
• History of genital HSV
• History positive testing for Group B strep infection
• History of a child with a diagnosis of Group B strep sepsis
• Pregnancy a result of donor egg or surrogacy
• Preexisting history of Type I or Type II Diabetes
• Maternal history of documented genital HPV infection, positive HPV testing or genital warts on physician examination
• Positive maternal testing for SARS-CoV-2 within 30 days of delivery or symptoms on admission suggesting potential Covid-19 infection