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

• ClinicalTrials.gov Identifier: NCT04232215
• Recruitment Status: Completed
• First Posted: January 18, 2020
• Results First Posted: March 20, 2023
• Last Update Posted: March 20, 2023
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Yvonne S. Butler Tobah, MD, Mayo Clinic

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Pregnancy Related
• Interventions: Device: HeraBEAT™; Device: Doppler fetal heart rate monitor
• Enrollment: 59

Participant Flow

Recruitment Details
Pre-assignment Details	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on routine fetal sonography. 4 of the 59 patients enrolled (i.e. signed consent) were not randomized and therefore withdrawn from the study,

Arm/Group Title	HeraBEAT™ Intervention Group, Then Standard Fetal Doppler	Standard Fetal Doppler Group, Then HeraBEAT™ Intervention
Arm/Group Description	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	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.
Period Title: First Intervention (8 Weeks)
Started	28	27
Completed	28	25
Not Completed	0	2
Reason Not Completed
Withdrawal by Subject	0	2
Period Title: Second Intervention (8 Weeks)
Started	28	25
Completed	28	1
Not Completed	0	24

Baseline Characteristics

Arm/Group Title		HeraBEAT™ Intervention, Then Standard Fetal Doppler Group	Standard Fetal Doppler Then HeraBEAT™ Intervention Group	Total
Arm/Group Description		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	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 of all reporting groups
Overall Number of Baseline Participants		28	24	52
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	24 participants	52 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	28 100.0%	24 100.0%	52 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	28 participants	24 participants	52 participants
		30.3 (4.5)	30.0 (3.3)	30.1 (3.9)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	24 participants	52 participants
	Female	28 100.0%	24 100.0%	52 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	24 participants	52 participants
	Hispanic or Latino	1 3.6%	0 0.0%	1 1.9%
	Not Hispanic or Latino	27 96.4%	24 100.0%	51 98.1%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	24 participants	52 participants
	American Indian or Alaska Native	1 3.6%	0 0.0%	1 1.9%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	1 4.2%	1 1.9%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	25 89.3%	23 95.8%	48 92.3%
	More than one race	1 3.6%	0 0.0%	1 1.9%
	Unknown or Not Reported	1 3.6%	0 0.0%	1 1.9%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	28 participants	24 participants	52 participants
		28	24	52

Outcome Measures

1. Primary Outcome

Title	Device Ease of Use
Description	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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	HeraBEAT™ Intervention Group	Standard Fetal Doppler Group
Arm/Group Description:	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	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.
Overall Number of Participants Analyzed	52	51
Mean (Standard Deviation); Unit of Measure: score on a scale
	72.8 (19.1)	75.1 (22.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HeraBEAT™ Intervention Group, Standard Fetal Doppler Group
	Comments	Difference in ease of use between our standard fetal Doppler and HeraBEAT™ device, as measured by the System Usability Survey (SUS) will be the primary outcome. We aim to recruit 50 participants (50 per arm, with cross-over) for a 99.7% power to detect a 10-point difference in SUS, as this accounts for a withdraw / post-randomization exclusion as high as 10% (assuming a proportion of expectant mothers to withdraw participation after being enrolled or found to not meet criteria after the fact).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.64
	Comments	[Not Specified]
	Method	Regression, Linear
	Comments	A generalized linear model adjusting by intervention group and the order of randomization was conducted.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -10.2 to 6.1
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Accurate Fetal Heart Rate Detection Where Values Are Between 110 and 160 Bpm
Description	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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	HeraBEAT™ Intervention Group	Standard Fetal Doppler Group
Arm/Group Description:	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	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.
Overall Number of Participants Analyzed	52	52
Measure Type: Count of Participants; Unit of Measure: Participants
	40 76.9%	42 80.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HeraBEAT™ Intervention Group, Standard Fetal Doppler Group
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.63
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; 0.57 to 2.53
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Up to 37 weeks, which includes 6-8 weeks postpartum.
Adverse Event Reporting Description	For the crossover study, adverse events were monitored during the initial group the patient was assigned to as well as the intervention they crossed over to. Therefore, all patients enrolled are evaluated for adverse events in both intervention groups.
Arm/Group Title	HeraBEAT™ Intervention Group	Standard Fetal Doppler Group
Arm/Group Description	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	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.
All-Cause Mortality
	HeraBEAT™ Intervention Group	Standard Fetal Doppler Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/52 (0.00%)	0/52 (0.00%)
Serious Adverse Events
	HeraBEAT™ Intervention Group	Standard Fetal Doppler Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/52 (0.00%)	0/52 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	HeraBEAT™ Intervention Group	Standard Fetal Doppler Group
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/52 (0.00%)	0/52 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Yvonne S. Butler Tobah, M.D.
• Organization: Mayo Clinic
• Phone: 507-284-0210
• EMail: ButlerTobah.Yvonne@mayo.edu

• Responsible Party: Yvonne S. Butler Tobah, MD, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04232215
• Other Study ID Numbers: 19-004708
• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Results First Submitted: January 26, 2023
• Results First Posted: March 20, 2023
• Last Update Posted: March 20, 2023