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Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.
NCT03298334 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Vaginal Seeding
- OTHER No Vaginal Seeding
Study Locations (1)
Virginia
- Inova Health System — Falls Church
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2018-07-01 |
| Est. Completion | 2029-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03298334
The ClinicalTrials.gov registry entry for NCT03298334 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Obesity, Childhood appearing as the primary indexed condition, and to 2 interventions — of which Vaginal Seeding is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03298334 reports 1 study location spanning 1 distinct geographic area — top geographies include Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03298334 about?
NCT03298334 is a clinical study titled "Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.". 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 an...
What is the current status of trial NCT03298334?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 600 participants. The study started on 2018-07-01. Estimated completion is 2029-04.
What conditions does trial NCT03298334 study?
This clinical trial studies the following conditions: Obesity, Childhood, Microbiota, Gastrointestinal Microbiome, Cesarean Delivery Affecting Newborn, Intestinal Microbiome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03298334?
The interventions under investigation include: Vaginal Seeding (BIOLOGICAL), No Vaginal Seeding (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03298334?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03298334 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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