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

NCT ID: NCT04232215

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-03
• Study Completion Date: 2022-08-31

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.

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.

Conditions

Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

HeraBEAT™

Intervention Type: DEVICE

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

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

Group Type: ACTIVE_COMPARATOR

Doppler fetal heart rate monitor

Intervention Type: 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.

Interventions

HeraBEAT™

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Yvonne S. Butler Tobah, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yvonne S Butler Tobah, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

19-004708

Identifier Type: -

Identifier Source: org_study_id