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NCT04301518 · ClinicalTrials.gov registry record · NA
Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs
A NA study of Preterm Birth and Preterm Labor, sponsored by Sera Prognostics.
- Active
- Registry status
- NA
- Development phase
- 6,500
- Enrollment target
- 18
- Study locations
NCT04301518: Active NA study of Preterm Birth and Preterm Labor, sponsored by Sera Prognostics.
NCT04301518 is a NA study of Preterm Birth and Preterm Labor that is active but no longer recruiting, run by Sera Prognostics. The registered enrollment target is 6,500 participants, above the 4,243-participant average among 39 other Preterm Birth trials with a reported enrollment target (53% higher). The trial reports 18 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04301518, a NA study of Preterm Birth and Preterm Labor, is active but no longer recruiting, sponsored by Sera Prognostics.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 6,500 participants
- Enrollment target
- 18
- Study locations
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.
Primary Outcome
Reduction in composite neonatal morbidity and mortality in the PTB Prevention arm versus the Control arm.
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 |
What the registry record for NCT04301518 still lists
NCT04301518 is an interventional study that assigns participants to a tested intervention. Its 6,500 participants enrollment target places it among the larger protocols in the corpus, above the 4,243-participant average among 39 other Preterm Birth trials with a reported enrollment target (53% higher).
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.
NCT04301518 lists 18 locations in 14 states (Virginia, Louisiana, Ohio).
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.
What interventions are being tested in trial NCT04301518?
The interventions under investigation include: Multimodal intervention strategy (OTHER).
Who is sponsoring clinical trial NCT04301518?
This trial is sponsored by Sera Prognostics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Preterm Birth
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04301518's enrollment target sits among peer trials
6,500 5th of 39 higher than 35 of 39 other Preterm Birth trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Preterm Birth trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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