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RecruitingCesarean Delivery Affecting NewbornObesity, ChildhoodIntestinal Microbiome

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

Eligible age

0–50 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

Yes

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About this study

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.

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

You may qualify if…

  • ✓ 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

You may not qualify if…

  • ✕ 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

Where it's recruiting

Virginia

Falls Church

Source: ClinicalTrials.gov · NCT03298334 · last updated 2025-06-08

Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered N · TrialPath