None listed
Conditions
Brief summary
The Royal Hospital for Women (RHW) in Randwick is implementing a new model of maternity care for women with pregnancy complications such as: a diagnosis of gestational hypertension, threatened premature labour (TPL) and/or premature pre-labour rupture of membranes (PPROM) called ‘Virtual Maternity Ward’. Women who have traditionally required inpatient admission, will be offered the opportunity to be care for at home by midwives and obstetricians from the RHW. The ‘Telemonitoring Simulation Study’ will simulate a telehealth clinic within RHW, aiming to establish the usability of a telemonitoring technology with a small cohort of inpatient women, obstetricians and midwives. The purpose of the study is to explore the feasibility and acceptability of a fetal telemonitoring device we may use in the future in the Virtual Maternity Ward. If the device we are evaluating in this study is found to be feasible and acceptable, we can commence work on developing interoperability with RHW technical infrastructures.
Interventions
The wearable fetal monitoring device is a non invasive fetal electrocardiogram device that measures fetal heart rate and maternal contractions. It is similar to the devices manufactured by Philips and GE for intrapartum fetal monitoring, that were registered by the TGA in 2018. This device was developed for antepartum monitoring at the University of Melbourne by Dr Emerson Keenan. It measures fetal heart rate and uterine activity during pregnancy, via adhesive abdominal patches that are not diss
The wearable fetal monitoring device is a non invasive fetal electrocardiogram device that measures fetal heart rate and maternal contractions. It is similar to the devices manufactured by Philips and GE for intrapartum fetal monitoring, that were registered by the TGA in 2018. This device was developed for antepartum monitoring at the University of Melbourne by Dr Emerson Keenan. It measures fetal heart rate and uterine activity during pregnancy, via adhesive abdominal patches that are not dissimilar to cardiac ECG patches. Further details and images are available at kalihealthcare.com Publications in the public domain about the device are listed at https://www.kalihealthcare.com/about/ The device is similar to devices used in The Netherlands and Scandinavia which have been in use for 10 years. Currently the European devices are not available in Australia, hence we are seeking to explore whether the Kail device may suit our needs in future. Fetal heart rate and uterine activity is monitored by the device The duration of administration is between 20-30 mins, similar to the duration of the interview with women participants Clinicians will not be using the telemonitoring in Simulation Study for any clinical purposes whatsoever. It is a simulation, meaning that the clinicians will view the digital platform and provide feedback about the feasibility of using the device and digital platform in the Virtual Maternity Ward in future. The clinical fetal monitoring of patients will be routinely administered separately, as per protocol, with the standard care device, cardiotocograph/ CTG. Interviews: Semi structured interviews will be conducted by a GCP trained PhD Candidate who is not involved in providing any clinical care to participants, herein referred to as the ‘Simulation Study interviewer’. The session will begin with the Simulation Study interviewer explaining the purpose of the fetal monitoring device and showing the participant how to apply the device. Field notes will be taken by the Simulation Study interviewer, to document any additional observations when the participant is applying the device, for example, whether she required little or a lot of assistance to apply the device. The session will continue with an interview about the participants’ views about hypothetically using the device at home, her actual experiences of being admitted to hospital (or visiting as an outpatient twice weekly or more) and her perceptions of hypothetically being cared for at home. Interviews are expected to take 20-30 minutes and will be conducted face to face in the Antenatal Ward or Pregnancy Day Stay Unit at RHW in a private space at the participants’ convenience. Interviews will be audio recorded. Recordings will be uploaded to a password protected UTS e-research folder and transcribed immediately. Transcription will take place in house at UTS, in two stages. Firstly, a draft will be prepared using the Microsoft Word Dictate function. Secondly, the interviewer will edit and correct the draft by cross checking with the audio recording. Transcribed interviews and field notes will be stored in a password protected UTS e-research folder as per the Data Storage Management Plan, as approved by the NSW Health SESLHD and UTS HRECs.
Sponsors
University of Technology Sydney
Study design
Allocation
Non-randomised trial
Primary purpose
Educational / counselling / training
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
- Pregnant women 18 years and over, who are diagnosed with either threatened premature labour (TPL), gestational hypertension or premature pre labour rupture of membranes (PPROM). - Admitted as antenatal inpatients at Royal Hospital for Women Randwick NSW (RHW) or frequently visiting outpatients (>twice weekly) for pregnancy monitoring - 32 weeks or more gestation or - Midwives or obstetricians/medical officers employed at RHW caring for participating women as above, of any age or gender. and - Willingness to provide verbal informed consent.
Exclusion criteria
-Women who have not provided consent to participate - Women with a psychological illness or condition such as to interfere with her ability to understand the requirements of the study. - Women with a fetus known to be incompatible with life (as this clinical circumstance brings added burden to the woman, her family and caregivers and is beyond the scope of this study).
Outcome results
None listed