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NCT03057275 · ClinicalTrials.gov registry record
Performance of the Monica Novii Wireless Patch System in Pre-term Labor
A clinical trial of Premature Labor, sponsored by GE Healthcare.
- Completed
- Registry status
- 47
- Enrollment target
- 1
- Study location
NCT03057275: Completed study of Premature Labor, sponsored by GE Healthcare.
NCT03057275 is a study of Premature Labor that has completed, run by GE Healthcare. The registered enrollment target is 47 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03057275, a study of Premature Labor, has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- 47 participants
- Enrollment target
- 1
- Study location
Study Summary
To study the equivalence of the Monica Novii™ Patch System in patients admitted for threatened pre-term labor and for pre-term labor \& delivery from 32 +0 weeks gestation by determining the equivalence of the Novii™ Patch System in monitoring Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contractions (UC) to Doppler FHR, tocodynamometer (TOCO) UC and photo plethysmograph MHR FDA approved predicates.
Primary Outcome
The fetal heart rate output file from the predicate device is processed to generate a time line plot of FHR data in which the epochs with un-interpretable data (e.g. no FHR value in that 2 second window) are removed to create "interpretable" only FHR data, i.e. the predicate is represented as 100% successful. A corresponding Monica Novii file is then generated that has the same time epochs as the Doppler FHR data set but containing the Novii FHR data or uninterpretable data (i.e. no FHR value).
Conditions Studied
Interventions
- DEVICE Abdominal fetal/maternal monitoring
Study Locations (1)
Arizona
- University of Arizona Medical Center - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2017-04-20 |
| Est. Completion | 2019-09-20 |
What the finished NCT03057275 record still lists
NCT03057275 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 47 participants, a relatively small participant target.
The record links to 1 condition, with Premature Labor appearing as the primary indexed condition, and to 1 intervention - of which Abdominal fetal/maternal monitoring is the first listed.
NCT03057275 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT03057275 about?
NCT03057275 is a clinical study titled "Performance of the Monica Novii Wireless Patch System in Pre-term Labor". To study the equivalence of the Monica Novii™ Patch System in patients admitted for threatened pre-term labor and for pre-term labor \& delivery from 32 +0 weeks gestation by determining the equivalence of the Novii™ Patch System in monitoring Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Ut...
What is the current status of trial NCT03057275?
This trial is currently completed. The enrollment target is 47 participants. The study started on 2017-04-20. Estimated completion is 2019-09-20.
What conditions does trial NCT03057275 study?
This clinical trial studies the following conditions: Premature Labor.
What interventions are being tested in trial NCT03057275?
The interventions under investigation include: Abdominal fetal/maternal monitoring (DEVICE).
Who is sponsoring clinical trial NCT03057275?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03057275 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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