Recruiting
Phase 1
Phase 2

Vaginal Microbiome

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT03298334

Conditions

Cesarean Delivery Affecting Newborn

Obesity, Childhood

Intestinal Microbiome

Microbiota

Host Microbial Interactions

Eligibility Criteria

Sex: All

Age: 0 - 50

Healthy Volunteers: Accepted

Interventions

Vaginal Seeding

No Vaginal Seeding

Study Details

Brief 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.

Conditions

Cesarean Delivery Affecting Newborn

Obesity, Childhood

Intestinal Microbiome

Microbiota

Host Microbial Interactions

Study ID

NCT03298334

Start date

Jul 1, 2018

Status verified date

Jun, 2025

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Receives Vaginal Seeding

sham comparator: No Vaginal Seeding

Interventions

Vaginal Seeding

A gauze containing the Mother's vaginal flora will be swabbed over the face and body of the neonate shortly after cesarean delivery.

No Vaginal Seeding

A gauze carrying sterile saline will be swabbed over the face and body of the neonate shortly after cesarean delivery.

Primary outcome measure

  • Adiposity [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Suchitra Hourigan, MD

703-776-8489suchitra.hourigan@inova.org, suchitra.hourigan@nih.gov

Shira Levy

703-776-8489shira.levy@inova.org

Locations

Inova Health System

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Suchitra Hourigan, MD

703-776-8489suchitra.hourigan@inova.org, suchitra.hourigan@nih.gov

General Information

microbiome@inova.org

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Jun 8, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2025-06-08.