Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
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 🦠 Gastrointestinal Microbiome
🗓️ Study Start (Actual) 1 July 2018
🗓️ Primary Completion (Estimated) April 2027
✅ Study Completion (Estimated) April 2029
👥 Enrollment (Estimated) 600
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Falls Church, Virginia, United States

📋 Eligibility Criteria

Description

  • 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
Ages Eligible for Study: 0 Days to 50 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 27 September 2017
  • First Submitted that Met QC Criteria 27 September 2017
  • First Posted 2 October 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 June 2024
  • Last Update Posted 18 June 2024
  • Last Verified June 2024