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NCT03156608 · ClinicalTrials.gov registry record · NA
Novii External Fetal Monitoring Device
A NA study, sponsored by Intermountain Health Care.
- Completed
- Registry status
- NA
- Development phase
- 218
- Enrollment target
NCT03156608: Completed NA study, sponsored by Intermountain Health Care.
NCT03156608 is a NA study that has completed, run by Intermountain Health Care. The registered enrollment target is 218 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03156608, a NA study, has completed, sponsored by Intermountain Health Care.
- COMPLETED
- Registry status
- NA
- Development phase
- 218 participants
- Enrollment target
Study Summary
This study will be conducted on women in labor. Fetal heart rate monitoring will be conducting using the Novii Fetal ECG/EMG system and comparing it to current standard of care external fetal heart rate and tocometry. These approaches will be compared with the respect to need for additional monitoring, amount of nursing intervention, cost and satisfaction of patients and healthcare providers.
Primary Outcome
Quality of the fetal heart rate for each minute of tracing will be assessed visually by 2 or more blinded reviewers. For the purpose of this study, uninterpretable fetal heart rate will be defined as continuous fetal heart rate data with one or more of the following: 1. Data is missing for more than 75% of the minute of tracing 2. Artifact is present for more than 25% of the minute of tracing 3. Missing data or artifact prevents determination of baseline rate 1. \> 15 seconds of continuous
Interventions
- DEVICE Novii ECG/EKG System
- DEVICE External fetal heart rate monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2017-03-06 |
| Est. Completion | 2017-06-28 |
| Phase | NA |
What the finished NCT03156608 record still lists
NCT03156608 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Novii ECG/EKG System is the first listed.
NCT03156608 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03156608 about?
NCT03156608 is a clinical study titled "Novii External Fetal Monitoring Device". This study will be conducted on women in labor. Fetal heart rate monitoring will be conducting using the Novii Fetal ECG/EMG system and comparing it to current standard of care external fetal heart rate and tocometry. These approaches will be compared with the respect to need for additional monitori...
What is the current status of trial NCT03156608?
This trial is currently completed. It is a NA study. The enrollment target is 218 participants. The study started on 2017-03-06. Estimated completion is 2017-06-28.
What interventions are being tested in trial NCT03156608?
The interventions under investigation include: Novii ECG/EKG System (DEVICE), External fetal heart rate monitoring (DEVICE).
Who is sponsoring clinical trial NCT03156608?
This trial is sponsored by Intermountain Health Care, which has 85 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03156608's enrollment target sits among peer trials
218 485th of 2000 higher than 1,516 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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