Mobile Phone Application Versus Handheld Device for Fetal Vibroacoustic Stimulation
Public ClinicalTrials.gov record NCT03446248. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Mobile Phone Application Versus Artificial Larynx for the Purpose of Vibroacoustic Stimulation in Fetal Non-stress Testing
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03446248
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2018
- Primary completion
- Dec 31, 2018
- Completion
- Dec 31, 2018
- Last update posted
- Apr 28, 2019
2018 – 2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hutzel Hospital | Detroit | Michigan | 48201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03446248, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 28, 2019 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03446248 live on ClinicalTrials.gov.