Actively Recruiting
Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2025-06-08
600
Participants Needed
1
Research Sites
561 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
J
Johns Hopkins University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mother scheduled for cesarean delivery at 37 weeks or later
- Pregnant with a single fetus, in good general health, and aged 18 years or older
- Negative maternal tests for infections transmitted through vaginal or other body fluids, including Gonorrhea, Chlamydia, Hepatitis B, Hepatitis C, Syphilis, HIV, and Group B strep
- Vaginal pH of 4.5 or less indicating Lactobacillus-dominated vaginal microbiota
- No maternal or fetal complications preventing microbiome restoration per protocol
- English or Spanish speaking
- Negative maternal testing for SARS-CoV-2 at delivery admission
- Women aged 18-29 years must have had a normal Pap test within the last 3 years
- Women aged 30-65 years must have had a normal Pap and HPV test within 5 years or equivalent approved testing
- Infant condition after delivery requires no more than standard neonatal resuscitation or is medically unable to receive the full vaginal microbiome transfer procedure
You will not qualify if you...
- Delivery at a hospital other than Inova Health System
- Cesarean delivery scheduled due to active infections interfering with vaginal delivery such as genital herpetic lesions
- Rupture of membranes before scheduled cesarean delivery
- Bacterial vaginosis within 30 days before cesarean delivery
- Symptomatic urinary tract infection within 30 days before cesarean delivery
- Antibiotic therapy within 30 days before cesarean delivery, except prophylaxis at surgery
- Symptoms on admission suggesting chorioamnionitis, such as maternal fever or fundal tenderness
- Symptoms on delivery admission suggesting vaginal infection like genital herpetic lesions
- History of genital herpes simplex virus
- History of positive Group B strep infection or a child with Group B strep sepsis
- Pregnancy resulting from donor egg or surrogacy
- Preexisting Type I or Type II diabetes
- Maternal history of documented genital HPV infection, positive HPV testing, or genital warts
- Positive maternal testing for SARS-CoV-2 within 30 days of delivery or symptoms suggesting COVID-19 infection on admission
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Inova Health System
Falls Church, Virginia, United States, 22042
Actively Recruiting
Research Team
S
Suchitra Hourigan, MD
CONTACT
S
Shira Levy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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