Mobile Phone Application Versus Handheld Device for Fetal Vibroacoustic Stimulation

NCT03446248 | Terminated

• 2 other identifiers: 1703000443040617MP2E
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

vibroacoustic stimulation

Outcome Measures

Primary Outcomes (1)

• Fetal heart rate accelerations

  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.

  within 15 minutes after vibroacoustic stimulation

Secondary Outcomes (1)

• Fetal heart rate decelerations

  within 15 minutes after vibroacoustic stimulation

Study Arms (2)

Fetal Acoustic Stimulator

ACTIVE COMPARATOR

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; Device: Mobile phone application

Mobile Phone Application

EXPERIMENTAL

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; Device: Mobile phone application

Interventions

Corometrics-146 device 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.

Fetal Acoustic Stimulator; Mobile Phone Application

Mobile phone application DEVICE

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.

Fetal Acoustic Stimulator; Mobile Phone Application

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Hutzel Hospital

Detroit, Michigan, 48201, United States

Location

Study Officials

• Michael S Awadalla, MD

  Resdient Physician at Wayne State University / Detroit Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 26, 2018
• Study Start: March 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)