Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000976482
Ethics application status
Approved
Date submitted
23/07/2025
Date registered
4/09/2025
Date last updated
4/09/2025
Date data sharing statement initially provided
4/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual Maternity Ward for women with pregnancy complications: pilot evaluation
Scientific title
Virtual Maternity Ward for women with pregnancy complications: pilot evaluation
Secondary ID [1] 314978 0
Nil known
Universal Trial Number (UTN)
WHO UTN U1111-1315-0712
Trial acronym
VMW
Linked study record
This study is related to registration record ACTRN12625000789460, and as such is linked.

Health condition
Health condition(s) or problem(s) studied:
Reproductive health and childbirth 338294 0
Fetal medicine and complications of pregnancy 338295 0
Condition category
Condition code
Reproductive Health and Childbirth 334593 334593 0 0
Antenatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
On October 7th 2025, the Royal Hospital for Women (RHW) in Randwick, NSW is launching a new model of maternity care called the 'Virtual Maternity Ward' (VMW) 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). Women who have traditionally required inpatient admission, will be offered the opportunity to be cared for at home by midwives and medical officers from the RHW. The midwifery team will consult with women regularly and collaborate with medical officers and escalate women’s care when required. The new model will combine remote blood pressure monitoring, a midwifery home visiting program and periodic outpatient visits to RHW.
A Virtual Maternity Ward Working Group was established at RHW in June 2024, membership of which includes a multidisciplinary group of clinicians, managers, researchers, digital health experts and women with the ‘lived’ experience of receiving complex pregnancy care.
This study, the ‘Virtual Maternity Ward Pilot Evaluation’ will evaluate the model of care, in a cohort of women who have been admitted to the VMW and are being cared for at home (n=20), partners/support people (n=15-20), health service managers (n=3-5) and clinicians (5-10).
Women and their partner participants will be recruited from those already admitted to the Virtual Maternity Ward by their treating clinician. Women participants will not be asked to participate in any procedures other than their standard course of treatment, as agreed to with their treating clinician. Hence, this study is OBSERVATIONAL only.
The aim of the ‘Virtual Maternity Ward Pilot Evaluation’ is to evaluate the model of care from the perspectives of technical, financial, operational, and logistic feasibility, and to pilot test the methods to inform the refinement of the model and design of future larger studies.
Data collected will include 1) semi structured interviews, 2) cost diaries and 3) data collected from medical records, all collected after participants' discharge from VMW.
1) Semi structured interviews will be conducted by a GCP trained research midwife/PhD
Candidate who will ask women participants about their views and experiences of being cared for at home in the Virtual Maternity Ward. Interviews are expected to take 20-30 minutes and will be conducted via an online platform or phone, according to the participants’ preferences
Semi structured interviews with clinicians and managers will be also conducted, after the last participant has been discharged from the VMW. The interview will ask clinicians about their views and experiences of providing care in the Virtual Maternity Ward model. Interviews are expected to take 20-30 minutes and will be conducted at RHW in a private space, or by phone, according to the participants’ preferences.
2) A pilot costing study will be included at both individual and hospital levels. To identify the costs of the Virtual Maternity Ward, payroll data identifying the salary costs of Virtual Maternity Ward and standard care midwives during the trial time will be extracted to identify amount of standard care midwife time required to deliver virtual episodes of care. To identify additional background health service use, electronic medical records will be extracted to identify participating women’s inpatient, outpatient and emergency department health service use from onset of antenatal care through to 6 weeks postpartum. We will also establish out of pocket costs for women through cost diaries.
3) Data extraction form medical records:
• Routinely collected perinatal outcomes data – eMaternity
o Demographic information including age, gestation at birth, parity, ethnicity
o Reason for admission
o Mode of birth – normal vaginal birth, emergency caesarean section, instrumental birth
o Medical and obstetric history
o Outpatient presentations to hospital
o Admissions as inpatients to hospital
o Length of admission to VMW
o Apgar scores below 7 at 5 minutes
o NICU admission of over 48 hours
o Length of stay in hospital
Intervention code [1] 331568 0
Not applicable
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342269 0
Feasibility of the Virtual Maternity Ward at RHW
Timepoint [1] 342269 0
Women and partners: after discharge from the Virtual Maternity Ward. Discharge date to be determined by treating clinician. Clinicians and managers: after the last woman participant has been discharged.
Primary outcome [2] 342637 0
Acceptability of the Virtual Maternity Ward
Timepoint [2] 342637 0
The interviews with women and partners will be conducted after the woman's discharge from the VMW. The interviews with clinicians and managers will be conducted after the last participant has been discharged from the VMW.
Secondary outcome [1] 450203 0
Carbon emissions - pilot of methods
Timepoint [1] 450203 0
End of study.
Secondary outcome [2] 450204 0
Cost - pilot of methods
Timepoint [2] 450204 0
End of study

Eligibility
Key inclusion criteria
Women:
• Women who have been admitted to the ‘Virtual Maternity Ward’ by their treating clinician.
• Willingness to provide written informed consent to participate in the research.
For partners/support people:
• Partners/family members or support people caring for participating women at home
• Willingness to provide verbal informed consent
For Clinicians:
• Registered midwife or medical officer employed at the Royal Hospital for Women
• Provided direct clinical care to women on the Virtual Maternity Ward
• Willingness to provide verbal informed consent
For Health Service Managers:
• Health Service Managers at RHW who have responsibility for staff working in the Virtual Maternity Ward
• 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
For Women:
• 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)
No exclusion criteria for clinicians and managers who meet inclusion criteria.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/10/2025
Actual
Date of last participant enrolment
Anticipated
28/02/2026
Actual
Date of last data collection
Anticipated
28/03/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 28235 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 44446 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 319531 0
Other Collaborative groups
Name [1] 319531 0
Maridulu Budyari Gumal SPHERE
Country [1] 319531 0
Australia
Funding source category [2] 319532 0
Government body
Name [2] 319532 0
NSW Health South East Sydney Local Health District
Country [2] 319532 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Country
Australia
Secondary sponsor category [1] 322031 0
Hospital
Name [1] 322031 0
Royal Hospital for Women Randwick
Address [1] 322031 0
Country [1] 322031 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318106 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 318106 0
Ethics committee country [1] 318106 0
Australia
Date submitted for ethics approval [1] 318106 0
05/11/2024
Approval date [1] 318106 0
12/02/2025
Ethics approval number [1] 318106 0
ETH2402168
Ethics committee name [2] 318107 0
UTS Health and Medical Research Ethics Committee
Ethics committee address [2] 318107 0
Ethics committee country [2] 318107 0
Australia
Date submitted for ethics approval [2] 318107 0
17/02/2025
Approval date [2] 318107 0
05/03/2025
Ethics approval number [2] 318107 0
ETH25_10572

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

Contacts
Principal investigator
Name 143138 0
A/Prof Deborah Fox
Address 143138 0
UTS Building 10, CB10.11.117, 235 Jones Street, Ultimo 2007 NSW
Country 143138 0
Australia
Phone 143138 0
+61295147982
Fax 143138 0
Email 143138 0
[email protected]
Contact person for public queries
Name 143139 0
Deborah Fox
Address 143139 0
UTS Building 10, CB10.11.117, 235 Jones Street, Ultimo 2007 NSW
Country 143139 0
Australia
Phone 143139 0
+61295147982
Fax 143139 0
Email 143139 0
[email protected]
Contact person for scientific queries
Name 143140 0
Deborah Fox
Address 143140 0
UTS Building 10, CB10.11.117, 235 Jones Street, Ultimo 2007 NSW
Country 143140 0
Australia
Phone 143140 0
+61295147982
Fax 143140 0
Email 143140 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.