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

NCT04232215 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2023-03-20

Study results available
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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

Interventions

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

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.

Sponsors & Collaborators

Principal Investigators

  • Yvonne S Butler Tobah, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-03
Primary Completion
2022-02-28
Completion
2022-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04232215 on ClinicalTrials.gov