Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates: a Randomized Controlled Trial
National Institute of Allergy and Infectious Diseases (NIAID)
600 participants
Jul 1, 2018
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria13
- 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
Exclusion Criteria15
- 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
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Interventions
A gauze containing the Mother's vaginal flora will be swabbed over the face and body of the neonate shortly after cesarean delivery.
A gauze carrying sterile saline will be swabbed over the face and body of the neonate shortly after cesarean delivery.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03298334