None listed
Conditions
Brief summary
Monitoring of the heartrate of the developing foetus (FHR) is an essential component of antenatal care. Monitoring FHR is currently restricted to in-clinic consultations with trained obstetric staff and appropriate medical equipment (hand-held doppler or cardiotocography (CTG)). The HeraBeat device is a new medical FHR monitor designed for use at home by the expectant mother, has been shown to be equivalent to existing gold standard FHR monitoring equipment and is approved for use in Australia. This study will examine the accuracy, usability and clinical utility of the HeraBeat device in the antenatal clinic and at home. This is a pilot study enrolling 60 participants. We will compare data accuracy against existing FHR monitors and assess usability of the device as rated by expectant mothers and antenatal clinic staff. More regular monitoring of FHR may result in improved pregnancy care.
Interventions
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 publi
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.
Sponsors
Paul Porter
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
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
Outcome results
None listed