Pregnancy RelatedNCT04232215
Medical Grade, Smartphone-based, Fetal Heart Rate Monitor for Outpatient Use
A study testing HeraBEAT™ and Doppler fetal heart rate monitor in people with Pregnancy Related, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- HeraBEAT™ and Doppler fetal heart rate monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 37Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- HeraBEAT™, Doppler fetal heart rate monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeraBEAT™Device
A wireless Smart Fetal Ultrasound Doppler measuring device designed to be self-administered by the expectant mother throughout the different stages of pregnancy
Doppler fetal heart rate monitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HeraBEAT™ Intervention Group | Experimental | 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 Receives: Device: HeraBEAT™ |
| Standard Fetal Doppler Group | Active comparator | 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 Receives: Device: Doppler fetal heart rate monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start3 Feb 2021
- Primary completion28 Feb 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yvonne S. Butler Tobah, MD, Mayo Clinic
- Investigators
- Yvonne S Butler Tobah, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232215
- Sponsor's protocol ID
- 19-004708
- Status last verified
- Feb 2023
- First submitted
- 15 Jan 2020
- Last updated
- 20 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Medical Grade, Smartphone-based, Fetal Heart Rate Monitor for Outpatient Use: the HeraBEAT™ Clinical Trial
- ClinicalTrials.gov ID
- NCT04232215
- Acronym / sponsor ID
- 19-004708
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 20 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After approximately 8 weeks of monitoring, patients will complete an ease of use survey, then crossover to the alternate study product.
| Arm | Type | Receives |
|---|---|---|
| HeraBEAT™ Intervention Group | Experimental | Device: HeraBEAT™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 |
| Standard Fetal Doppler Group | Active comparator | Device: Doppler fetal heart rate monitorSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (37 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | HeraBEAT™ Intervention Group |
| Doppler fetal heart rate monitorA 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. | Device | Standard Fetal Doppler Group |
Primary outcome
Device Ease of Use
Time frame: 8 weeks
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.
Accurate Fetal Heart Rate Detection Where Values Are Between 110 and 160 Bpm
Time frame: 8 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne S Butler Tobah, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeraBEAT™ and Doppler fetal heart rate monitor in people with Pregnancy Related, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Ease of Use (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.