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Mobile Phone Application Versus Handheld Device for Fetal Vibroacoustic Stimulation

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ClinicalTrials.gov Identifier: NCT03446248
Recruitment Status : Terminated (low recruitment)
First Posted : February 26, 2018
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Awadalla, Wayne State University

Brief 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.


Condition or disease Intervention/treatment Phase
Pregnancy Device: Corometrics-146 device Device: Mobile phone application Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Mobile Phone Application Versus Artificial Larynx for the Purpose of Vibroacoustic Stimulation in Fetal Non-stress Testing
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2019

Arm Intervention/treatment
Active Comparator: Fetal Acoustic Stimulator
Participants in this group will receive fetal vibroacoustic stimulation with the Corometrics-146 device first, followed by the mobile phone application second.
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.

Experimental: Mobile Phone Application
Participants in this group will receive fetal vibroacoustic stimulation with the mobile phone application first, followed by the Corometrics-146 device second.
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.




Primary Outcome Measures :
  1. Fetal heart rate accelerations [ Time Frame: within 15 minutes after vibroacoustic stimulation ]
    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.


Secondary Outcome Measures :
  1. Fetal heart rate decelerations [ Time Frame: within 15 minutes after vibroacoustic stimulation ]
    Percentage of time that significant fetal heart rate decelerations (60 beats per minute for at least 60 seconds) occur within 15 minutes after vibroacoustic stimulation with a method.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant patients at 32 to 42 weeks gestation who are already undergoing fetal heart rate monitoring in the hospital setting at Hutzel Hospital in Detroit, Michigan in triage, the antepartum floor, or on labor and delivery.

Exclusion Criteria:

  • Clinically unstable patients, patient who have been on magnesium sulfate or had opioid administration within the last 4 hours, fetuses with intrauterine growth restriction, patients contracting more than 3 times in 10 minutes, and twin pregnancies or higher order multiples.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446248


Locations
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United States, Michigan
Hutzel Hospital
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: Michael S Awadalla, MD Resdient Physician at Wayne State University / Detroit Medical Center

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Responsible Party: Michael Awadalla, Resident Physician, Wayne State University
ClinicalTrials.gov Identifier: NCT03446248     History of Changes
Other Study ID Numbers: 1703000443
040617MP2E ( Other Identifier: Wayne State University IRB )
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Awadalla, Wayne State University:
vibroacoustic stimulation