Vaginal microbiome exposure for newborns delivered by C-section

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of vaginal microbiome seeding on health outcomes in newborns delivered via scheduled Cesarean section. Infants will be randomly assigned to receive either exposure to their mother's vaginal flora or a sham treatment at birth. The study aims to assess the impact of this intervention on the development of the gut microbiome, immune function, and metabolic outcomes over a three-year period. The trial is divided into two phases, with the first phase focusing on microbiota composition and the second phase evaluating body mass index and immune-mediated outcomes in a larger cohort.

Why it matters

Who can join: the full rules

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 it's running

• Inova Health System
  Falls Church, Virginia, United States Recruiting

Study contacts

• Principal investigator: Suchitra Hourigan, MD, Chief, Clinical Microbiome Unit, NIAID, Pediatric Gastroenterologist — National Institute of Allergy and Infectious Diseases (NIAID), Inova Children's Hospital
• Study coordinator: Suchitra Hourigan, MD
• Email: suchitra.hourigan@inova.org, suchitra.hourigan@nih.gov
• Phone: 703-776-8489

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.