Vaginal Microbiome Seeding for Cesarean-Delivered Babies

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

Recruiting Phase 1 Phase 2 Interventional Study
Cesarean Delivery Affecting Newborn Obesity, Childhood Intestinal Microbiome Microbiota Host Microbial Interactions Gastrointestinal Microbiome
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
0 Days – 50
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Prevention
Participants needed
600 (estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · NIH
Who this trial is looking for

This trial is looking for mothers scheduled for a C-section who are interested in helping their babies develop healthy gut bacteria. Participants will have their infants exposed to the mother's vaginal bacteria after birth, and the babies will be followed for three years to track their health.

Are You a Good Fit for This Trial?
Rules you out DiabetesGenital HPV infectionHistory of Group B strep infection

You may be able to join if

  • I am scheduled for a C-section at 37 weeks or later.
  • I am in good general health.
  • I am 18 years or older.
  • I speak English or Spanish.
  • I tested negative for certain infections in early pregnancy.
  • I tested negative for Group B strep during pregnancy.
  • I do not have any complications that would prevent the procedure.
  • My vaginal health is good based on testing.

You may not be able to join if

  • I am delivering at a hospital that is not Inova Health System.
  • I have an active infection that could complicate the delivery.
  • I have had a rupture of membranes before my C-section.
  • I have bacterial vaginosis or a urinary tract infection within the past 30 days.
  • I have taken antibiotics within the past 30 days, except for surgery prep.
  • I have experienced symptoms of infection during my admission.
  • I have a history of genital herpes.
  • I have tested positive for SARS-CoV-2 within the past 30 days.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This 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.

Trial Locations
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Eligibility Criteria
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 pre…
Contacts

Suchitra Hourigan, MD

703-776-8489

suchitra.hourigan@inova.org, suchitra.hourigan@nih.gov

CONTACT

Shira Levy

703-776-8489

shira.levy@inova.org

CONTACT