Clinical trials

The clinical trials currently in progress are quite involved, have pasted some of the details from the ANZ clinical trials register.

Bit of volume going through today..

Regards,

TCG


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]
None
Universal Trial Number (UTN)
U1111-1252-5255
Trial acronym

Linked study record


Health condition
Health condition(s) or problem(s) studied:
Pregnancy
Foetal Health
Condition category
Condition code
Reproductive Health and Childbirth
Antenatal care
Reproductive Health and Childbirth
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.

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]
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]

During first clinic visit (at time of enrollment) - phase 1
Primary outcome [2]
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]
Phase 1. During first clinic visit at time of enrollment into the study.
Primary outcome [3]
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]
Assessment will occur during phase 3, being the single home-based telehealth consultation 2-4 weeks after enrollment.
Secondary outcome [1]
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]
First study visit as part of phase 1
Secondary outcome [2]
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]
First study visit as part of phase 2
Secondary outcome [3]
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]
Primary outcome.
During first study visit (at time of enrollment) - phase 2
Secondary outcome [4]
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]
Primary outcome.
During first clinic visit (at time of enrollment) - phase 2