Trial Outcomes & Findings for Medical Grade, Smartphone-based, Fetal Heart Rate Monitor for Outpatient Use (NCT NCT04232215)
NCT ID: 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
NA
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on routine fetal sonography. 4 of the 59 patients enrolled (i.e. signed consent) were not randomized and therefore withdrawn from the study,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
| 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
| 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
| 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=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
30.3 years
STANDARD_DEVIATION 4.5 • n=99 Participants
|
30.0 years
STANDARD_DEVIATION 3.3 • n=107 Participants
|
30.1 years
STANDARD_DEVIATION 3.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
24 participants
n=107 Participants
|
52 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: 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.
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.
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 weeksPopulation: 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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place