Medical Grade, Smartphone-based, Fetal Heart Rate Monitor for Outpatient Use

NCT04232215 | Completed Results FDA Device

• 1 other identifier: 19-004708
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are assessing the ease of use and accuracy of the HeraBEAT™ device, a new device used with a smartphone to monitor fetal heart rate during pregnancy.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• Device Ease of Use

  Measured using the self-reported System Usability Scale (SUS) on 10 items, each on a scale from 1 to 5 (1 = strongly disagree and 5= strongly agree). A composite score is calculated with a range of 0-100 where higher values indicated a high usability of device, whereas lower scores indicate less usability of the device.

  8 weeks

• Accurate Fetal Heart Rate Detection Where Values Are Between 110 and 160 Bpm

  Number of patients to detect a fetal heart rate accurately using the device. An inaccurate assessment is considered any value less than 110 or greater than 160 bpm. A patient with at least one inaccurate value is counted as an event of interest. Patients without an inaccurate event will be counted as a success.

  8 weeks

Study Arms (2)

HeraBEAT™ Intervention Group

EXPERIMENTAL

Subjects will monitor their fetal heart beat once weekly using the HeraBEAT™ device. After approximately 8 weeks of monitoring subjects will crossover to using the doppler fetal heart rate monitor

Device: HeraBEAT™

Standard Fetal Doppler Group

ACTIVE COMPARATOR

Subjects will monitor their fetal heart beat once weekly using the doppler fetal heart rate monitor. After approximately 8 weeks of monitoring subjects will crossover to using the HeraBEAT™ device

Device: Doppler fetal heart rate monitor

Interventions

HeraBEAT™ DEVICE

A wireless Smart Fetal Ultrasound Doppler measuring device designed to be self-administered by the expectant mother throughout the different stages of pregnancy

HeraBEAT™ Intervention Group

Doppler fetal heart rate monitor DEVICE

A hand-held ultrasound transducer that uses the Doppler Effect to provide an audible simulation of the heart beat and displays the number of beats per minute.

Standard Fetal Doppler Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Able to speak, read and understand English
• Able to provide informed consent
• Owns a suitable iOS or Android device and demonstrates average control and basic understanding of using a smartphone
• At least 12 weeks gestation
• Pregnancy documented as low risk

You may not qualify if:

• Any observed anomalies on first trimester dating or formal ultrasound
• Multifetal gestation
• Maternal history of defibrillation
• Maternal history of electro-surgery
• Patients with external electrical stimulators, cardiac pacemakers or requiring use of MRI or other high frequency medical equipment
• Clinical judgment that determines that the pregnancy is at high risk for complications
• Any of the following high risk factors would disqualify the mother for the study:
• Abnormal fetal anatomy
• Chronic hypertension, including severe hypertension (\>160/110)
• Possible ectopic pregnancy or pregnancy of unknown location
• Multi-fetal pregnancy
• Hypertensive disorders (chronic hypertension, gestational diabetes, preeclampsia)
• Prior Pulmonary Embolism / Deep Vein Thrombosis / stroke
• Anticoagulation during prior pregnancy (e.g. antiphospholipid antibody syndrome)
• Prosthetic heart valve (non-bio)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Yvonne S. Butler Tobah, M.D.
• Organization: Mayo Clinic

ButlerTobah.Yvonne@mayo.edu

507-284-0210

Study Officials

• Yvonne S Butler Tobah, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: After approximately 8 weeks of monitoring, patients will complete an ease of use survey, then crossover to the alternate study product.

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: February 3, 2021
• Primary Completion: February 28, 2022
• Study Completion: August 31, 2022
• Last Updated: March 20, 2023
• Results First Posted: March 20, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)