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Mobile Phone Application Versus Handheld Device for Fetal Vibroacoustic Stimulation

NCT03446248 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-04-29

No results posted yet for this 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.

Conditions

  • Pregnancy

Interventions

DEVICE

Corometrics-146 device

Fetal vibroacoustic stimulation with the Corometrics-146 fetal acoustic stimulator will be performed by placing the device on the maternal skin halfway between the pubic symphysis and the umbilicus and activating the device for 3 seconds.

DEVICE

Mobile phone application

Fetal vibroacoustic stimulation with the mobile phone will be performed by placing and iPhone on the maternal skin halfway between the pubic symphysis and umbilicus and using the application to activate for 3 seconds the phone's built in vibration along with a 2,000 Hz tone at a sound level of 74 decibels when measured at 1 meter.

Sponsors & Collaborators

  • Wayne State University

    lead OTHER

Principal Investigators

  • Michael S Awadalla, MD · Resdient Physician at Wayne State University / Detroit Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-01-01
Completion
2019-01-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03446248 on ClinicalTrials.gov