Status:
RECRUITING
Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Johns Hopkins University
Rutgers University
Conditions:
Cesarean Delivery Affecting Newborn
Obesity, Childhood
Eligibility:
All Genders
Up to 50 years
Phase:
PHASE1
PHASE2
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 exam...
Detailed Description
Cesarean section (CS) delivery is a common surgical procedure intended to increase the chances of successful delivery and to protect the health of the mother and baby. Yet this intervention is overuse...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03298334
Start Date
July 1 2018
End Date
April 1 2029
Last Update
June 8 2025
Active Locations (1)
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1
Inova Health System
Falls Church, Virginia, United States, 22042