Trial Outcomes & Findings for Medical Grade, Smartphone-based, Fetal Heart Rate Monitor for Outpatient Use (NCT NCT04232215)

Last Updated: 2023-03-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

59 participants

Primary outcome timeframe

8 weeks

Results posted on

2023-03-20

Participant Flow

Participants will be asked to discontinue the study if their pregnancy is subsequently diagnosed as high risk, or if cardiac or cranial anomalies are identified on routine fetal sonography. 4 of the 59 patients enrolled (i.e. signed consent) were not randomized and therefore withdrawn from the study,

Participant milestones

Participant milestones
Measure	HeraBEAT™ Intervention Group, Then Standard Fetal Doppler 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 HeraBEAT™: 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, Then HeraBEAT™ Intervention 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 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.
First Intervention (8 Weeks) STARTED	28	27
First Intervention (8 Weeks) COMPLETED	28	25
First Intervention (8 Weeks) NOT COMPLETED	0	2
Second Intervention (8 Weeks) STARTED	28	25
Second Intervention (8 Weeks) COMPLETED	28	1
Second Intervention (8 Weeks) NOT COMPLETED	0	24

Reasons for withdrawal

Reasons for withdrawal
Measure	HeraBEAT™ Intervention Group, Then Standard Fetal Doppler 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 HeraBEAT™: 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, Then HeraBEAT™ Intervention 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 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.
First Intervention (8 Weeks) Withdrawal by Subject	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HeraBEAT™ Intervention, Then Standard Fetal Doppler Group n=28 Participants 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 HeraBEAT™: 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 Then HeraBEAT™ Intervention Group n=24 Participants 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 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.	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	24 Participants n=7 Participants	52 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.3 years STANDARD_DEVIATION 4.5 • n=5 Participants	30.0 years STANDARD_DEVIATION 3.3 • n=7 Participants	30.1 years STANDARD_DEVIATION 3.9 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	24 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	24 participants n=7 Participants	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: As this is a crossover trial, all patients participate in both arms. The arms above indicate the first intervention they are randomized to. The survey was administered after completion of each intervention group, this is why the number of participants is larger.

Outcome measures

Outcome measures
Measure	HeraBEAT™ Intervention Group n=52 Participants 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 HeraBEAT™: 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 n=51 Participants 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 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.
Device Ease of Use	72.8 score on a scale Standard Deviation 19.1	75.1 score on a scale Standard Deviation 22.5

PRIMARY outcome

Timeframe: 8 weeks

Population: As this study is a crossover study, all patients participate in each intervention group. The number analyzed reflects the number of participants that had fetal heart rate detection when they were participating in that group.

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.

Outcome measures

Outcome measures
Measure	HeraBEAT™ Intervention Group n=52 Participants 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 HeraBEAT™: 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 n=52 Participants 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 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.
Accurate Fetal Heart Rate Detection Where Values Are Between 110 and 160 Bpm	40 Participants	42 Participants

Adverse Events

HeraBEAT™ Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Fetal Doppler Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yvonne S. Butler Tobah, M.D.

Mayo Clinic

Phone: 507-284-0210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place