Medical Grade, Smartphone-based, Fetal Heart Rate Monitor for Outpatient Use
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pregnancy Related
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention 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)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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) an...
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.
Tracking Information
- NCT #
- NCT04232215
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Yvonne S Butler Tobah, MD Mayo Clinic
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