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NCT03409146 · ClinicalTrials.gov registry record
Accuracy and Reliability of Novii: Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contraction (UA) Compared With Doppler, Scalp Fetal Scalp Electrode (FSE), Tocodynamometer (TOCO) and Intra Uterine Pressure Catheter (IUPC)
A clinical trial, sponsored by GE Healthcare.
- Completed
- Registry status
- 80
- Enrollment target
NCT03409146: Completed study, sponsored by GE Healthcare.
NCT03409146 is a clinical trial that has completed, run by GE Healthcare. The registered enrollment target is 80 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03409146 has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- 80 participants
- Enrollment target
Study Summary
Accuracy and Reliability of the Novii device (fetal heart rate, maternal heart rate and uterine activity) compared with Food and Drug Administration (FDA) approved techniques
Primary Outcome
PPA(%)=(a/(a+C))x100, where "a" represents the number of 2 second epochs when the Novii FHR is within +/-10% of the predicate device FHR for each 2 second epoch, and "c" are the number of 2 second epochs when the Novii FHR is not within +/- 10% of the predicate device FHR or is absent.
Interventions
- DEVICE Monica Novii Wireless Patch System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2014-05-28 |
| Est. Completion | 2017-02-13 |
What the finished NCT03409146 record still lists
NCT03409146 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Monica Novii Wireless Patch System is the first listed.
NCT03409146 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03409146 about?
NCT03409146 is a clinical study titled "Accuracy and Reliability of Novii: Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contraction (UA) Compared With Doppler, Scalp Fetal Scalp Electrode (FSE), Tocodynamometer (TOCO) and Intra Uterine Pressure Catheter (IUPC)". Accuracy and Reliability of the Novii device (fetal heart rate, maternal heart rate and uterine activity) compared with Food and Drug Administration (FDA) approved techniques
What is the current status of trial NCT03409146?
This trial is currently completed. The enrollment target is 80 participants. The study started on 2014-05-28. Estimated completion is 2017-02-13.
What interventions are being tested in trial NCT03409146?
The interventions under investigation include: Monica Novii Wireless Patch System (DEVICE).
Who is sponsoring clinical trial NCT03409146?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
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