Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000739910
Ethics application status
Approved
Date submitted
22/05/2020
Date registered
16/07/2020
Date last updated
28/10/2021
Date data sharing statement initially provided
16/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the reliability and ease of use of a remote foetal heart rate monitor as used by expectant mothers at home. The HeraBEAT Trial
Scientific title
An evaluation of the clinical utility and acceptability of maternally-administered foetal heart rate monitoring using a remote medical device

The HeraBEAT Trial.
Secondary ID [1] 301331 0
None
Universal Trial Number (UTN)
U1111-1252-5255
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 317377 0
Foetal Health 317378 0
Condition category
Condition code
Reproductive Health and Childbirth 315478 315478 0 0
Antenatal care
Reproductive Health and Childbirth 315824 315824 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Design:
This is a single centre open-label clinical study involving the recording of FHR by clinical staff and expectant mothers in the Joondalup Health Campus (JHC) antenatal clinic and at home using the HeraBEAT device.

The HeraBEAT device is a TGA approved Foetal Heart Rate (FHR) monitor. FHR is an indicator of foetal health and is an essential part of the antenatal visit. At present this is a key factor missing in the transition from face-to-face to remote visits. HeraBEAT is publically available for use without clinical overview. HeraBEAT is a wireless smart foetal ultrasound doppler measuring device designed to be self-administered by pregnant women. The HeraBEAT device safety and performance claims allow continuous and accurate measurement of foetal heart rate (FHR) and maternal heart rate (MHR) throughout the pregnancy, starting at 12 weeks gestation.

The investigators wish to determine the accuracy, usability and clinical utility of the device in the Joondalup Health Campus (JHC) Antenatal clinic and when the expectant mothers take the device home for use in a telemedicine consultation (the consultation is not a part of the project and is not a new intervention).

The intervention is in three phases.
Phases 1 and 2 will occur during the same visit, followed by a single telehealth appointment 2 weeks later

1. Initial assessment by clinical staff (JHC antenatal clinic)
During this phase, the HeraBEAT device will be used by the obstetrician or midwife. Each subject will have a simultaneous FHR measurement with usual care monitoring (handheld doppler or CTG) taken to compare to the HeraBEAT result for accuracy and the time taken to obtain FHR data on the connected smartphone will be undertaken.

2. Use and assessment by expectant mother (JHC antenatal clinic)
During this phase, a trained midwife/registered nurse will demonstrate how to use the device independently. The participant will then use the HeraBEAT device, unaided, and an assessment of ease of use measured using System Usability Scale (SUS), including the time taken to obtain FHR data on her connected smartphone will be undertaken.

3. Home monitoring (remote)
During this phase, a device will be sent home with the expectant mother. Using the HeraBEAT device a continuous FHR trace will be recorded by the mother on the day of her telehealth antenatal appointment. The trace will be of at least 1 minute duration and will be electronically transmitted to the obstetrician/midwife for review during the consultations. An assessment of the transmission, including data clarity and clinical utility, will be made by the antenatal team. The mother will return the device at her next in-person antenatal appointment.

Duration: Each participant will complete their contribution over a 4 week period.
Intervention code [1] 317523 0
Early detection / Screening
Comparator / control treatment
The device under evaluation (HeraBEAT) will be compared against standard care FHR-monitoring (using hand-held doppler or cardiotocography (CTG). Both devices will be applied simultaneously to each patient (ie internal control) and to all patients in the study (ie no allocation to treatment/control arms).
Control group
Active

Outcomes
Primary outcome [1] 323723 0
1. Foetal Heart Rate detection by clinicians.
I. The percentage of clinicians able to detect an accurate FHR using the device;


A usable and accurate FHR is defined as follows.
An obstetrician will review all HeraBEAT FHR traces to determine the ability to detect the presence of the following standard features:
a. Baseline FHR (bpm) within the range of 80-180 bpm
b. FHR variability (Y/N) (Variability is defined as the minor fluctuations around the baseline FHR. It is assessed by estimating the difference in beats per minute between the highest peak and lowest trough of fluctuation in one-minute segments of the trace between contractions.)
c. Accelerations in the FHR (Y/N). An acceleration is defined as a transient increase in FHR above the baseline. Accelerations may not always occur in recordings of short duration.)
d. Length of continuous FHR recording is > 1minute (Y/N)
Timepoint [1] 323723 0

During first clinic visit (at time of enrollment) - phase 1
Primary outcome [2] 323724 0
2. Accuracy of FHR recordings from HeraBEAT device against standard-of-care (hand-held doppler or CTG) monitors currently used in the JHC antenatal clinic. Comparison of FHR shall be done simultaneously between HeraBEAT and standard of care monitors currently used in the JHC antenatal clinic (hand-held doppler or CTG).
This is a composite outcome as all measurements add to the single accuracy outcome.
A measurement for comparison (taken by clinical staff) will be made in the following way:
a. Preparation:
i. Devices for comparison will be simultaneously placed on the participant.
ii. Both devices shall measure the FHR until stable recordings are obtained.
iii. Should the devices not be able to measure the HR in a continuous manner, the participant will be excluded from the comparison measurement part of the trial.
b. Measurement:
i. Measurement will be taken by clinical staff once the data has stabilized.
ii. A Measurement will be taken every ~15 seconds.
iii. A measurement will be comprised of 5 samples of each device. For every 5 samples the average will be calculated and used as a measurement set comparison.
Timepoint [2] 323724 0
Phase 1. During first clinic visit at time of enrollment into the study.
Primary outcome [3] 323725 0
Assessment of quality and clinical utility of FHR trace transmitted from the expectant mother to the antenatal clinic (this is not part of clinical care). This is a composite outcome as the two measures are interdependent.
A usable and accurate FRH is defined as follows.
An obstetrician will review all HeraBEAT FHR traces to determine the ability to detect the presence of the following standard features:
a. Baseline FHR (between 80-180bpm)
b. FHR variability (Y/N) (Variability is defined as the minor fluctuations around the baseline FHR. It is assessed by estimating the difference in beats per minute between the highest peak and lowest trough of fluctuation in one-minute segments of the trace between contractions.)
c. Accelerations in the FHR (Y/N). An acceleration is defined as a transient increase in FHR above the baseline. Accelerations may not always occur in recordings of short duration.)
d. Length of continuous FHR recording is > 1minute (Y/N)
Timepoint [3] 323725 0
Assessment will occur during phase 3, being the single home-based telehealth consultation 2-4 weeks after enrollment.
Secondary outcome [1] 382729 0
Device ease of use for clinicians. This will be measured using the self-reported System Usability Scale (SUS) on a scale from 1 to 5 (1 = strongly disagree and 5= strongly agree)
Timepoint [1] 382729 0
First study visit as part of phase 1
Secondary outcome [2] 383584 0
Device ease of use for expectant mothers. This will be measured using the self-reported System Usability Scale (SUS) on a scale from 1 to 5 (1 = strongly disagree and 5= strongly agree)
Timepoint [2] 383584 0
First study visit as part of phase 2
Secondary outcome [3] 383585 0
This is an additional Primary outcome.

1. Foetal Heart Rate detection by expectant mothers..
I. The percentage of participants able to detect an accurate FHR (defined as per below) using the device;

A usable and accurate FHR recording is defines as follows.
An obstetrician will review all HeraBEAT FHR traces to determine the ability to detect the presence of the following standard features:
a. Baseline FHR (between 80 and 180bpm)
b. FHR variability (Y/N) (Variability is defined as the minor fluctuations around the baseline FHR. It is assessed by estimating the difference in beats per minute between the highest peak and lowest trough of fluctuation in one-minute segments of the trace between contractions.)
c. Accelerations in the FHR (Y/N). An acceleration is defined as a transient increase in FHR above the baseline. Accelerations may not always occur in recordings of short duration.)
d. Length of continuous FHR recording is > 1minute (Y/N)
Timepoint [3] 383585 0
Primary outcome.
During first study visit (at time of enrollment) - phase 2
Secondary outcome [4] 384074 0
This is an additional primary outcome.

The time taken for expectant mothers to detect a FHR from the time the “START” button is pressed on the connected smartphone. This value is automatically reported on the FHR trace.
Timepoint [4] 384074 0
Primary outcome.
During first clinic visit (at time of enrollment) - phase 2

Eligibility
Key inclusion criteria
Any expectant mother over 18 years of age with a singleton pregnancy who is attending the Joondalup Health Campus antenatal clinic from 12 weeks gestation. Participants will be recruited as a convenience sample after eligibility is assessed.
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Twin, triplets or other multi-foetal pregnancies
2. Non-English readers
3. Informed consent not obtained
4. No access to an appropriate smartphone or internet connectivity
5. Pacemaker or other implantable electronic devices
6. Skin condition or rash in the abdominal area
7. Anterior placenta
8. In active labour

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study designed to explore feasibility of using the HeraBEAT device in the antenatal clinic. As there is no control group, descriptive results will be presented for the whole cohort.

1. Foetal Heart Rate detection will be reported as categorical values:
I. The percentage of participants able to detect an accurate FHR (defined as per below) using the device;
II. The time taken for participants to detect a FHR from the time the “START” button is pressed on the connected smartphone. This value is automatically reported on the FHR trace.

Accuracy of FHR monitoring: Accuracy of the device (against CTG/hand-held doppler) will be calculated as follows:
The measurement comparison will be deemed successful/not-successful if the limits of agreement (LOA’s) for FHR between HeraBEAT and the standard of care device are within the interval [-8.7211, 8.4] Bpm.

Assessment of quality and clinical utility of FHR trace: will be presented as categorical data:
a. Baseline FHR (bpm) detectable (Y/N)
b. FHR variability (Y/N) (Variability is defined as the minor fluctuations around the baseline FHR. It is assessed by estimating the difference in beats per minute between the highest peak and lowest trough of fluctuation in one-minute segments of the trace between contractions.)
c. Accelerations in the FHR (Y/N). An acceleration is defined as a transient increase in FHR above the baseline. Accelerations may not always occur in recordings of short duration.)
d. Length of continuous FHR recording is > 1minute (Y/N)

4. Device ease of use for expectant mothers and clinicians. This will be measured using the self-reported System Usability Scale (SUS) on a scale from 1 to 5 (1 = strongly disagree and 5= strongly agree) with scoring as per established methods. Average score will be determined.

Baseline characteristics will be reported with continuous values reported as means and standard deviations or median interquartile range as appropriate. Categorical values will be reported as counts and proportion. Two sample t-tests or Wilcoxon-rank sum test and chi-squared tests or Fishers exact test will be used as appropriate. Any baseline imbalances (p<0.05) will be explored as a possible confounder to adjust for when the outcome measures are analysed.

We will adhere to the STARD guidelines to transparently report study results and ensure that sufficient information is included to allow for assessment of the study’s internal and external validity.

Comparing ease of use metrics will be done using an ANCOVA analysis or generalized estimating equation as appropriate adjusting for gestational age and BMI.

A study statistician will be appointed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/07/2020
Actual
16/07/2020
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
120
Accrual to date
81
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 16628 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 30223 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 305668 0
Hospital
Name [1] 305668 0
Joondalup Health Campus
Country [1] 305668 0
Australia
Funding source category [2] 305673 0
Commercial sector/Industry
Name [2] 305673 0
HeraMED Ltd
Country [2] 305673 0
Israel
Primary sponsor type
Individual
Name
Paul Porter
Address
Suite 204 Medical Centre
Joondalup Health Campus
Cnr Grand Blvd & Shenton Ave
JOONDALUP WA 6027
Country
Australia
Secondary sponsor category [1] 306079 0
None
Name [1] 306079 0
Address [1] 306079 0
Country [1] 306079 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305952 0
Ramsay Health Care NSW VIC HREC
Ethics committee address [1] 305952 0
Ethics committee country [1] 305952 0
Australia
Date submitted for ethics approval [1] 305952 0
12/05/2020
Approval date [1] 305952 0
22/06/2020
Ethics approval number [1] 305952 0
2020-005

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102186 0
A/Prof Paul Porter
Address 102186 0
c/o Suite 204, Specialist Medical Centre West
Joondalup Health Campus
Cnr Shenton Ave & Grand Blvd
JOONDALUP WA 6027
Country 102186 0
Australia
Phone 102186 0
+61 08 9400 9919
Fax 102186 0
Email 102186 0
[email protected]
Contact person for public queries
Name 102187 0
Paul Porter
Address 102187 0
c/o Suite 204, Specialist Medical Centre West
Joondalup Health Campus
Cnr Shenton Ave & Grand Blvd
JOONDALUP WA 6027
Country 102187 0
Australia
Phone 102187 0
+61 08 9400 9919
Fax 102187 0
Email 102187 0
[email protected]
Contact person for scientific queries
Name 102188 0
Paul Porter
Address 102188 0
c/o Suite 204, Specialist Medical Centre West
Joondalup Health Campus
Cnr Shenton Ave & Grand Blvd
JOONDALUP WA 6027
Country 102188 0
Australia
Phone 102188 0
+61 08 9400 9919
Fax 102188 0
Email 102188 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified individual participant data underlying published results to allow independent statistical analysis.
When will data be available (start and end dates)?
Start: Upon acceptance of peer-reviewed manuscript in an appropriate journal.
Finish: no end day determined
Available to whom?
Fellow researchers in the field
Available for what types of analyses?
Confirmatory analysis. Not for use in other research unless separate HREC approval obtained.
How or where can data be obtained?
On request to Principal investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8504Ethical approval    379782-(Uploaded-14-07-2020-17-48-16)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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