Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000789460
Ethics application status
Approved
Date submitted
28/10/2024
Date registered
25/07/2025
Date last updated
25/07/2025
Date data sharing statement initially provided
25/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual Maternity Ward for women with pregnancy complications: telemonitoring simulation study
Scientific title
Virtual Maternity Ward for women with pregnancy complications: telemonitoring simulation study
Secondary ID [1] 313248 0
Nil known
Universal Trial Number (UTN)
UTN U1111-1315-0712
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertensive disorder of pregnancy 335582 0
Premature prelabour rupture of membranes in pregnancy 335583 0
Threatened premature labour in pregnancy 335585 0
Condition category
Condition code
Reproductive Health and Childbirth 332155 332155 0 0
Antenatal care
Reproductive Health and Childbirth 332156 332156 0 0
Other reproductive health and childbirth disorders
Cardiovascular 332221 332221 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329842 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339743 0
Simulation Study: Feasibility and acceptability of telemonitoring, to participating women
Timepoint [1] 339743 0
Data collected at one timepoint between 32 weeks gestation and the onset of labour.
Secondary outcome [1] 450202 0
Simulation Study: Feasibility and acceptability of telemonitoring, to RHW clinicians
Timepoint [1] 450202 0
One timepoint as per convenience of clinician

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Thematic analysis of interview data

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/08/2025
Actual
Date of last participant enrolment
Anticipated
23/03/2026
Actual
Date of last data collection
Anticipated
30/03/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27280 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 43367 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 317692 0
University
Name [1] 317692 0
University of Technology Sydney
Country [1] 317692 0
Australia
Funding source category [2] 317712 0
Government body
Name [2] 317712 0
NSW Health South East Sydney Local Health District
Country [2] 317712 0
Australia
Funding source category [3] 319362 0
Other Collaborative groups
Name [3] 319362 0
Maridulu Budyari Gumal SPHERE
Country [3] 319362 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Country
Australia
Secondary sponsor category [1] 320031 0
None
Name [1] 320031 0
Address [1] 320031 0
Country [1] 320031 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316388 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 316388 0
Ethics committee country [1] 316388 0
Australia
Date submitted for ethics approval [1] 316388 0
05/11/2024
Approval date [1] 316388 0
12/02/2025
Ethics approval number [1] 316388 0
ETH2402168
Ethics committee name [2] 318020 0
UTS Health and Medical Research Ethics Committee
Ethics committee address [2] 318020 0
Ethics committee country [2] 318020 0
Australia
Date submitted for ethics approval [2] 318020 0
17/02/2025
Approval date [2] 318020 0
05/03/2025
Ethics approval number [2] 318020 0
ETH25_10572

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

Contacts
Principal investigator
Name 137742 0
A/Prof Deborah Fox
Address 137742 0
University of Technology Sydney, PO Box 123, Broadway NSW 2007
Country 137742 0
Australia
Phone 137742 0
+61295147982
Fax 137742 0
Email 137742 0
[email protected]
Contact person for public queries
Name 137743 0
Deborah Fox
Address 137743 0
University of Technology Sydney, PO Box 123, Broadway NSW 2007
Country 137743 0
Australia
Phone 137743 0
+61295147982
Fax 137743 0
Email 137743 0
[email protected]
Contact person for scientific queries
Name 137744 0
Deborah Fox
Address 137744 0
University of Technology Sydney, PO Box 123, Broadway NSW 2007
Country 137744 0
Australia
Phone 137744 0
+61295147982
Fax 137744 0
Email 137744 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.