NCT03298334 · National Institute of Allergy and Infectious Diseases (NIAID)
Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
What this study is about
Neonates delivered by scheduled Cesarean Section will be randomly assigned 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 side effects.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Falls Church, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2025 · Source of record for eligibility and locations