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

Feasibility and Acceptability of a Medical Grade, Smartphone-based, Fetal Heart Rate Monitor for Outpatient Use: the HeraBEAT™ Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Device: HeraBEAT™; Device: Doppler fetal heart rate monitor

Detailed Description

The HeraBEAT™ is a wireless Smart Fetal Ultrasound Doppler measuring device designed to be self-administered by the expectant mother throughout the different stages of pregnancy. The HeraBEAT™ device safety and performance claims allow continuous and accurate measurement of fetal heart rate (FHR) and maternal heart rate (MHR) throughout the pregnancy starting at 12 weeks gestation.

Technologically, HeraBEAT™ is similar to other FHR devices currently on the market in terms of device usage but differ by design in its interface. The HeraBEAT™ device uses a smartphone-based interface, with real time instructions for expectant mothers for determining both MHR and FHR.

This study will recruit low risk expectant mothers from the Obstetrics and Gynecology Department at Mayo Clinic Rochester. This is a mixed method; single center randomized controlled trial comparing HeraBEAT™ to a standard home fetal Doppler monitor, in the outpatient setting at a single academic institution, in the mid-west United States. The overall study will be guided by an assessment of device functionality and user acceptability, as well as an evaluation of the impact of the device on expectant mother's perception of fetal well-being, as measured by standardized surveys.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
  • Pulmonary hypertension
  • Mothers currently taking Immunosuppressants, Prednisone > 10mg per day)
  • Women with mental health disorders (including eating disorders, severe depression, on antipsychotics)
  • Recurrent pregnancy loss (>2 losses)
  • Current maternal malignancy
  • Prior myocardial infarction/cardiomyopathy
  • Bio-prosthetic heart valves
  • Marfan syndrome
  • Active liver disease (e.g. hepatitis)
  • Congenital heart disease
  • Coagulopathies including thrombophilias and bleeding disorders.
  • Pre-existing diabetes
  • Genetic disease/Cystic Fibrosis testing/anomalies in prior child
  • Incompetent cervix (prior cerclage)
  • Isoimmunization (Rh, Kell, etc.)
  • History of transplant or currently on Dialysis
  • Prior 2nd or 3rd trimester loss
  • Human Immunodeficiency Virus (HIV)
  • Inflammatory bowel disease
  • Asthma and currently on steroid to control disease
  • History of preterm delivery <37 weeks
  • BMI >40 (class 3 obesity)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HeraBEAT™ Intervention Group; 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™; A wireless Smart Fetal Ultrasound Doppler measuring device designed to be self-administered by the expectant mother throughout the different stages of pregnancy
Active Comparator: Standard Fetal Doppler Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 19-004708

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes