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

Study Overview
=================
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.

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

Conditions
-----------------
Pregnancy Related

Intervention / Treatment
-----------------
* Device: HeraBEAT™
* Device: Doppler fetal heart rate monitor


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: After approximately 8 weeks of monitoring, patients will complete an ease of use survey, then crossover to the alternate study product.
Masking: None (Open Label)


Arms and Interventions

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

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 |