Vaginal seeding for babies born by planned cesarean section
Tests swabbing newborns with the mother's vaginal bacteria after cesarean birth, compared with a sham.
Plain-language title generated from the registry record
Registry title: Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
Key facts
- Where
- Falls Church, United StatesSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for pregnant women with a planned cesarean birth and their newborns. Babies get vaginal seeding or a sham procedure and are followed for three years.
- Age
- Mothers: 18 years or older. Babies: newborns. The registry lists an overall age range of 0 days to 50 years.
- Sex
- All
- Disease stage
- Single baby, scheduled cesarean delivery at 37 weeks or later, mother in good general health.
- Earlier treatment
- Mothers must not have had antibiotics in the 30 days before the cesarean, except medicine given at the time of surgery.
- Biomarker or test result
- Vaginal pH of 4.5 or lower. Negative tests for Group B strep, gonorrhea, chlamydia, hepatitis B, hepatitis C, syphilis, HIV and SARS-CoV-2. Normal Pap test, with an HPV test for women aged 30-65 years.
Main reasons for not taking part
- Cesarean planned because of an active infection, or symptoms of infection on admission
- Bacterial vaginosis or urinary tract infection in the 30 days before the cesarean
- History of genital HSV, genital HPV or Group B strep
- Type I or Type II diabetes before pregnancy
- Pregnancy through donor egg or surrogacy
This trial only enrols pregnant participants. The registry sentence this rests on: Pregnant with single fetus, in good general health, age 18 years or older
Read by machine on 12 November 2026.
Where in United States
- Inova Health SystemFalls Church, United StatesContact: Suchitra Hourigan, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- National Institute of Allergy and Infectious Diseases (NIAID)
- Trial code
- NCT03298334
- Record updated
- 8 June 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Rupture of membranes prior to scheduled cesarean delivery; Antibiotic therapy within 30 days of cesarean delivery (exclusive of medication use for prophylaxis at the time of surgery); Cesarean delivery scheduled for active infection that would have interfered with vaginal delivery such as genital herpetic lesions; Symptomatic urinary tract infection within 30 days of cesarean delivery; 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; 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; Delivery at a hospital other than Inova Health System; Bacterial vaginosis within 30 days of cesarean delivery; Symptoms on admission suggesting Chorioamnionitis, e.g. maternal fever, fundal tenderness; Pregnancy a result of donor egg or surrogacy.