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NCT03446248 · ClinicalTrials.gov registry record · NA
Mobile Phone Application Versus Handheld Device for Fetal Vibroacoustic Stimulation
A NA study, sponsored by Wayne State University.
- Terminated
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT03446248: Clinical Trial NA study, sponsored by Wayne State University.
NCT03446248 is a NA study that was terminated before completion, run by Wayne State University. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03446248, a NA study, was terminated before completion, sponsored by Wayne State University.
- TERMINATED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a randomized controlled single blinded crossover study to compare fetal vibroacoustic stimulation with a handheld device to a mobile phone application designed for this study. The handheld device, the Corometrics model 146, was previously marketed and sold for fetal stimulation and is modeled after devices used as artificial larynxes. The mobile phone application uses an iPhone's built in vibration with acoustic stimulation from the speaker at 2,000 Hz frequency at a sound level of 74 decibels when measured at 1 meter distance. The investigators' hypothesis is that the mobile phone application will elicit a fetal response (defined as one or more fetal heart rate accelerations in 15 minutes) at a similar rate to that of the handheld device. Fetal vibroacoustic stimulation is commonly used during antenatal tests of fetal well being such as a non-stress test. Fetal vibroacoustic stimulation works by arousing the fetus to a state of wakefulness during which reassuring fetal movements and associated fetal heart rate accelerations occur. During a non-stress test, two or more fetal heart rate accelerations in 20 minutes constitutes a reassuring test. Fetal vibroacoustic stimulation has been shown to decrease the false positive rate of non-stress testing without increasing the false negative rate. This study will compare the frequency that one or more fetal heart rate accelerations occur in the 15 minutes after vibroacoustic stimulation with the Corometrics-146 fetal acoustic stimulator compared to after vibroacoustic stimulation with a mobile phone application designed for the study.
Primary Outcome
The primary outcome will be the percentage of the time that one or more fetal heart rate accelerations occur within 15 minutes after vibroacoustic stimulation with a method.
Interventions
- DEVICE Corometrics-146 device
- DEVICE Mobile phone application
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2019-01-01 |
| Phase | NA |
Why NCT03446248 stopped before completion
NCT03446248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Corometrics-146 device is the first listed.
NCT03446248 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03446248 about?
NCT03446248 is a clinical study titled "Mobile Phone Application Versus Handheld Device for Fetal Vibroacoustic Stimulation". This is a randomized controlled single blinded crossover study to compare fetal vibroacoustic stimulation with a handheld device to a mobile phone application designed for this study. The handheld device, the Corometrics model 146, was previously marketed and sold for fetal stimulation and is modele...
What is the current status of trial NCT03446248?
This trial is currently terminated. It is a NA study. The enrollment target is 30 participants. The study started on 2018-03-01. Estimated completion is 2019-01-01.
What interventions are being tested in trial NCT03446248?
The interventions under investigation include: Corometrics-146 device (DEVICE), Mobile phone application (DEVICE).
Who is sponsoring clinical trial NCT03446248?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03446248's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 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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