Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates: a Randomized Controlled Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 0 Days to 50 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 3 years
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events."
- "The investigators will obtain clinical information from in-person visits, surveys and the electronic health record."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests vaginal seeding, which exposes a newborn to germs from the mother's vagina, compared with a pretend treatment. It is for mothers with a planned C-section and their babies, who are assigned to a group by chance. Researchers will follow babies for 3 years to study their germs, immune system, how their bodies use energy, and any harmful effects.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Mother is at least 18, in good health, and pregnant with one baby. C-section is planned for 37 weeks or later.
- Mother speaks English or Spanish. Neither mother nor baby has problems that would prevent the study procedure.
- Mother has negative routine tests early in pregnancy for infections spread through vaginal or other body fluids.
- Mother tests negative for Group B strep bacteria at 35–37 weeks, and for gonorrhea, chlamydia, hepatitis B and C, syphilis, and HIV at 35 weeks or later.
- Mother's vaginal pH, a measure of acidity, is 4.5 or lower. This suggests that Lactobacillus bacteria are the main germs present.
- Ages 18–29: normal Pap test within 3 years. Ages 30–65: normal Pap plus HPV testing within 5 years, an FDA-approved high-risk HPV test alone within 5 years, or a normal Pap alone within 3 years. These tests check for cervical cell changes or HPV virus.
- Mother tests negative for the virus that causes COVID-19 during routine testing when admitted for delivery at Inova Health System.
- The listed infant rule allows babies who need only routine help after birth, such as drying, gentle rubbing, suction, or oxygen without pressure. It also lists babies medically unable to receive the full vaginal seeding procedure.
Who can't join
- Delivery outside Inova Health System, or the mother's water breaks before the planned C-section.
- C-section is planned because of an active infection that would prevent vaginal birth, or mother has signs of a vaginal infection when admitted.
- Mother had bacterial vaginosis (an imbalance of vaginal bacteria), a urinary tract infection with symptoms, or antibiotics within 30 days of delivery. Antibiotics to prevent infection during surgery are allowed.
- Mother has signs of infection around the baby when admitted, such as fever or tenderness over the womb.
- Mother has a history of genital herpes, a positive Group B strep test, or a child who had a serious blood infection from Group B strep.
- Pregnancy used a donor egg or a surrogate, or mother had type 1 or type 2 diabetes before pregnancy.
- Mother has a recorded history of genital HPV infection, a positive HPV test, or genital warts found by a doctor.
- Mother tested positive for the virus that causes COVID-19 within 30 days of delivery, or has possible COVID-19 symptoms when admitted.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
VA
- Inova Health System · Falls Church, VA 22042Suchitra Hourigan, MD · Study contact · 703-776-8489 · suchitra.hourigan@inova.org, suchitra.hourigan@nih.govGeneral Information · Study contact · microbiome@inova.orgAnkit Shah, MD · Sub-investigatorMore trials in Falls Church