NCT03298334 Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
| NCT ID | NCT03298334 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Condition | Cesarean Delivery Affecting Newborn |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2018-07-01 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 600 participants in total. It began in 2018-07-01 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.
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 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
Contact & Investigator
Suchitra Hourigan, MD, Chief, Clinical Microbiome Unit, NIAID, Pediatric Gastroenterologist
PRINCIPAL INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID), Inova Children's Hospital
Frequently Asked Questions
Who can join the NCT03298334 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 50 Years, studying Cesarean Delivery Affecting Newborn. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03298334 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03298334 currently recruiting?
Yes, NCT03298334 is actively recruiting participants. Contact the research team at suchitra.hourigan@inova.org, suchitra.hourigan@nih.gov for enrollment information.
Where is the NCT03298334 trial being conducted?
This trial is being conducted at Falls Church, United States.
Who is sponsoring the NCT03298334 clinical trial?
NCT03298334 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). The principal investigator is Suchitra Hourigan, MD, Chief, Clinical Microbiome Unit, NIAID, Pediatric Gastroenterologist at National Institute of Allergy and Infectious Diseases (NIAID), Inova Children's Hospital. The trial plans to enroll 600 participants.