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Vaginal Seeding for Cesarean-delivered Babies

This study is looking at whether exposing babies born by C-section to their mother's vaginal fluids right after birth can improve their health. This is called "Vaginal Seeding." Babies will either receive Vaginal Seeding (a gauze with the mother's vaginal flora swabbed on them) or a sham treatment (a gauze with sterile saline). Researchers believe that C-section babies might miss out on important microbes from their mother, which could affect their health later on. This study will follow babies for three years to see if Vaginal Seeding helps with their microbiome development, immune system, and metabolic health. The main goal is to see if it affects adiposity (body fat) at two years old. Mothers who are scheduled for a C-section at 37 weeks or more, are in good health, and have negative tests for certain infections may be eligible. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 600 participants. Babies will be randomly assigned to receive either Vaginal Seeding or a sham treatment.
What's involved
Infants will be followed for three years to examine health outcomes. The primary endpoint, adiposity, will be measured at two years.
Compensation
Not stated in the trial record.
Follow-up
Infants will be followed for three years after birth.

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NCT03298334

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

Recruiting
PHASE1Ages 0–50InterventionalPrevention
National Institute of Allergy and Infectious Diseases (NIAID)
~600 participants
Updated 2025-06-08 on ClinicalTrials.gov
What's tested:Vaginal SeedingNo Vaginal Seeding

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adiposity
Measured over 2 years

Conditions

Cesarean Delivery Affecting Newborn
Obesity, Childhood
Intestinal Microbiome
Microbiota
Host Microbial Interactions
Gastrointestinal Microbiome

Explore related trials

Deliveries by cesarean

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Suchitra Hourigan, MD, Chief, Clinical Microbiome Unit, NIAID, Pediatric Gastroenterologist · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID), Inova Children's Hospital
  • Noel Mueller, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
  • Maria Gloria Dominguez Bello, PhD · PRINCIPAL_INVESTIGATOR · Rutgers University
  • Lawrence Appel, MD, MPH · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Suchitra Hourigan, MD
[email protected], [email protected]
703-776-8489
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

Exclusion

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

What this trial measures

  • Adiposity2 years

    E.g. Body mass index z-score