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Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs
NCT04301518 · View on ClinicalTrials.gov ↗
Study Summary
This prospective, randomized, controlled study evaluates the safety and efficacy of a preterm birth (PTB) prevention strategy versus standard of care pregnancy management to reduce the incidence of adverse pregnancy outcomes.
Conditions Studied
Interventions
- OTHER Multimodal intervention strategy
Study Locations (18)
Virginia
- University of Virginia — Charlottesville
- Inova Health Care Services — Falls Church
- VPFW — Richmond
Louisiana
- Ochsner — New Orleans
- LSU — Shreveport
Ohio
- Cleveland Clinic — Cleveland
- Ohio Health — Columbus
California
- UCSD — San Diego
Connecticut
- Yale — New Haven
Delaware
- Delaware/Christiana Care — Newark
Florida
- Emerald Coast — Panama City
Kentucky
- University of Kentucky Healthcare — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,500 participants |
| Start Date | 2020-11-06 |
| Est. Completion | 2026-12-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04301518
The ClinicalTrials.gov registry entry for NCT04301518 describes a study currently listed as active not recruiting. It is categorized as NA, 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 6,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sera Prognostics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Preterm Birth appearing as the primary indexed condition, and to 1 intervention — of which Multimodal intervention strategy 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: NCT04301518 reports 18 study locations spanning 14 distinct geographic areas — top geographies include Virginia, Louisiana, Ohio. 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 NCT04301518 about?
NCT04301518 is a clinical study titled "Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs". This prospective, randomized, controlled study evaluates the safety and efficacy of a preterm birth (PTB) prevention strategy versus standard of care pregnancy management to reduce the incidence of adverse pregnancy outcomes.
What is the current status of trial NCT04301518?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 6,500 participants. The study started on 2020-11-06. Estimated completion is 2026-12-30.
What conditions does trial NCT04301518 study?
This clinical trial studies the following conditions: Preterm Birth, Preterm Labor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04301518?
The interventions under investigation include: Multimodal intervention strategy (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04301518?
This trial is sponsored by Sera Prognostics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04301518 being conducted?
This trial has 18 study locations across California, Connecticut, Delaware, Florida, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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