Pregnancy Related
Conditions
Brief 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.
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.
Interventions
DEVICEHeraBEAT™
A wireless Smart Fetal Ultrasound Doppler measuring device designed to be self-administered by the expectant mother throughout the different stages of pregnancy
DEVICEDoppler 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
After approximately 8 weeks of monitoring, patients will complete an ease of use survey, then crossover to the alternate study product.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Ease of Use | 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 | 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. |
Countries
United States
Participant flow
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,
Participants by arm
| Arm | Count |
|---|---|
| HeraBEAT™ Intervention, Then Standard Fetal Doppler Group 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 | 28 |
| Standard Fetal Doppler Then HeraBEAT™ Intervention Group 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. | 24 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (8 Weeks) | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | HeraBEAT™ Intervention, Then Standard Fetal Doppler Group | Standard Fetal Doppler Then HeraBEAT™ Intervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 24 Participants | 52 Participants |
| Age, Continuous | 30.3 years STANDARD_DEVIATION 4.5 | 30.0 years STANDARD_DEVIATION 3.3 | 30.1 years STANDARD_DEVIATION 3.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 24 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 25 Participants | 23 Participants | 48 Participants |
| Region of Enrollment United States | 28 participants | 24 participants | 52 participants |
| Sex: Female, Male Female | 28 Participants | 24 Participants | 52 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 0 / 52 | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HeraBEAT™ Intervention Group | Accurate Fetal Heart Rate Detection Where Values Are Between 110 and 160 Bpm | 40 Participants |
| Standard Fetal Doppler Group | Accurate Fetal Heart Rate Detection Where Values Are Between 110 and 160 Bpm | 42 Participants |
p-value: 0.6395% CI: [0.57, 2.53]Chi-squared
Primary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HeraBEAT™ Intervention Group | Device Ease of Use | 72.8 score on a scale | Standard Deviation 19.1 |
| Standard Fetal Doppler Group | Device Ease of Use | 75.1 score on a scale | Standard Deviation 22.5 |
Comparison: 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).p-value: 0.6495% CI: [-10.2, 6.1]Regression, Linear