Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
NCT ID: NCT03298334
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
600 participants
INTERVENTIONAL
2018-07-01
2029-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Impact of Cervical Cerclage or Vaginal Progesterone on Vaginal Microbiome Distribution
NCT03253016
Dilators for Dyspareunia Prevention
NCT01299363
Skip Prep of Vaginal Delivery to Prevent Puerperal / Perinatal Infection in Vaginal Delivery
NCT05122169
Maternal Consequences of Membrane Stripping
NCT06373250
Mouth Guard Use in the Second Stage of Labor
NCT03520530
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
While restoring labor is not possible, restoring the microbes that colonize infants during birth through exposure to vaginal flora, is feasible, and has been shown in a small pilot study, to normalize the microbiota of the intestine, skin and mouth during the first month of life.
The investigators hypothesize that the restoration of the vaginal microbiota to the infant at birth will restore the infant microbiome and decrease the risk of obesity and other immune-mediated diseases linked with CS. The investigators aim to test this hypothesis in a randomized controlled trial by first examining the effect of vaginal seeding, in CS-delivered newborns, on the gut microbiota composition, structure and function (Phase I of study; first 50 infants) and then on the BMI z score and other immune-mediated outcomes (Phase II of study; 600 infants).
Methods: CS-delivered neonates will be randomized to either an experimental arm with exposure to the maternal vaginal microbiota at birth, or a control arm with no exposure. Feces, skin, saliva, breast milk, and vaginal swabs will be collected for microbiome analysis. The investigators will obtain clinical information from in-person visits, surveys and the electronic health record.
Implications: this randomized controlled clinical study will provide evidence of whether the "vaginal seeding" procedure can safely transfer microbes from mom-to-baby, and whether these microbes are beneficial for the metabolic and immune health of the child.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Receives Vaginal Seeding
Vaginal Seeding
A gauze containing the Mother's vaginal flora will be swabbed over the face and body of the neonate shortly after cesarean delivery.
No Vaginal Seeding
No Vaginal Seeding
A gauze carrying sterile saline will be swabbed over the face and body of the neonate shortly after cesarean delivery.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vaginal Seeding
A gauze containing the Mother's vaginal flora will be swabbed over the face and body of the neonate shortly after cesarean delivery.
No Vaginal Seeding
A gauze carrying sterile saline will be swabbed over the face and body of the neonate shortly after cesarean delivery.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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
* 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
0 Days
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Johns Hopkins University
OTHER
Rutgers University
OTHER
Inova Health Care Services
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Suchitra Hourigan, MD, Chief, Clinical Microbiome Unit, NIAID, Pediatric Gastroenterologist
Role: PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID), Inova Children's Hospital
Noel Mueller, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Maria Gloria Dominguez Bello, PhD
Role: PRINCIPAL_INVESTIGATOR
Rutgers University
Lawrence Appel, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Inova Health System
Falls Church, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Dominguez-Bello MG, De Jesus-Laboy KM, Shen N, Cox LM, Amir A, Gonzalez A, Bokulich NA, Song SJ, Hoashi M, Rivera-Vinas JI, Mendez K, Knight R, Clemente JC. Partial restoration of the microbiota of cesarean-born infants via vaginal microbial transfer. Nat Med. 2016 Mar;22(3):250-3. doi: 10.1038/nm.4039. Epub 2016 Feb 1.
Song SJ, Wang J, Martino C, Jiang L, Thompson WK, Shenhav L, McDonald D, Marotz C, Harris PR, Hernandez CD, Henderson N, Ackley E, Nardella D, Gillihan C, Montacuti V, Schweizer W, Jay M, Combellick J, Sun H, Garcia-Mantrana I, Gil Raga F, Collado MC, Rivera-Vinas JI, Campos-Rivera M, Ruiz-Calderon JF, Knight R, Dominguez-Bello MG. Naturalization of the microbiota developmental trajectory of Cesarean-born neonates after vaginal seeding. Med. 2021 Aug 13;2(8):951-964.e5. doi: 10.1016/j.medj.2021.05.003. Epub 2021 Jun 17.
Hourigan SK, Dominguez-Bello MG, Mueller NT. Can maternal-child microbial seeding interventions improve the health of infants delivered by Cesarean section? Cell Host Microbe. 2022 May 11;30(5):607-611. doi: 10.1016/j.chom.2022.02.014.
Namasivayam S, Tilves C, Ding H, Wu S, Domingue JC, Ruiz-Bedoya C, Shah A, Bohrnsen E, Schwarz B, Bacorn M, Chen Q, Levy S, Dominguez Bello MG, Jain SK, Sears CL, Mueller NT, Hourigan SK. Fecal transplant from vaginally seeded infants decreases intraabdominal adiposity in mice. Gut Microbes. 2024 Jan-Dec;16(1):2353394. doi: 10.1080/19490976.2024.2353394. Epub 2024 May 14.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17-2694
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.