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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Sep 27, 2017

Keywords

ClinConnect Summary

This clinical trial is studying the effects of vaginal microbiome seeding on newborns delivered by cesarean section. Essentially, this means that some babies will be exposed to their mother’s vaginal bacteria right after birth, while others will not. The researchers want to see how this exposure affects the babies' health over the next three years, looking specifically at their gut health, immune system development, and any other health outcomes, such as the risk of obesity.

To be eligible for this trial, mothers need to be at least 18 years old, scheduled for a cesarean delivery at 37 weeks or later, and in good health, among other criteria. Babies must have a condition that allows for standard care right after delivery. If you or someone you know is interested in participating, you can expect regular follow-ups for three years to monitor the baby’s health and development. This study is important because it could help us understand how early exposure to certain bacteria might influence a child's future health.

Gender

ALL

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