Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001094460
Ethics application status
Approved
Date submitted
15/08/2025
Date registered
8/10/2025
Date last updated
8/10/2025
Date data sharing statement initially provided
8/10/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Performance evaluation of an ultrasound perfusion system with pregnant population in rural and remote communities.
Scientific title
Testing the performance of a low-cost purpose-designed ultrasound perfusion system as a way to reduce stillbirth and perinatal hypoxic damage in pregnant women in rural and remote communities.
Secondary ID [1] 315142 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fetal wellbeing 338570 0
Fetal tissue perfusion 338571 0
Condition category
Condition code
Reproductive Health and Childbirth 334872 334872 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 334873 334873 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study's objective is to evaluate the feasibility and acceptability of our ultrasound device and its predictive ability for stillbirth or hypoxic fetal compromise in a high-risk population in low resourced settings.
Our portable ultrasound machine has been manufactured using commercially available components assembled by IDE Group under ISO13485 and IEC62304 regulatory compliance standards.
An ultrasound scan will be performed using this machine looking at the blood flow within the baby's liver, kidney, brain and placenta, performed by an appropriately credentialed sonographer. The ultrasound will be performed for approximately 20-30 minutes for each study recruitment and will take place in a conventional scanning environment (within a healthcare facility). A core team member has visited the remote site to ensure adherence to protocol and observed a scan being undertaken to ensure adherence to the intervention protocol.
Intervention code [1] 331841 0
Early detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342501 0
Acceptability (1): of automated 3D-FMBV to healthcare participants
Timepoint [1] 342501 0
At the end of the intervention period for all participants.
Primary outcome [2] 342715 0
Acceptability (2): of automated 3D-FMBV to healthcare practitioners
Timepoint [2] 342715 0
At the end of the intervention period for all participants.
Primary outcome [3] 342716 0
Performance of the automated ‘Imaging Chain’ involved in this research (from image acquisition through cloud analysis to returned results): Percentage success rate for image data volumes passing through the chain.
Timepoint [3] 342716 0
At the end of the intervention period for all participants.
Secondary outcome [1] 451073 0
Performance of 3D-FMBV novel indices in prediction of stillbirth and hypoxic perinatal outcomes; using a composite outcome with anticipation of very few cases of stillbirth so using near miss criteria to detect potential hypoxic perinatal outcomes. The novel indices evaluated include perfusion as expressed by 3D-FMBV in fetal liver, brain and kidney plus placenta, along with ratios of organ perfusion measurements.
Timepoint [1] 451073 0
End of study period for all participants.
Secondary outcome [2] 452679 0
Performance of the automated ‘Imaging Chain’ involved in this research (from image acquisition through cloud analysis to returned results): Time taken at each point in the Imaging Chain.
Timepoint [2] 452679 0
At cessation of the study.

Eligibility
Key inclusion criteria
Inclusion Criteria: The study will include women carrying singleton fetuses; gestational age between 28- and 40-weeks gestation, determined by the last menstrual period and where possible confirmed by first trimester ultrasound; normal fetus on morphology scan. Having previously determined normograms for fetal organ perfusion, this study will not be entirely focused on the ‘normal’ population; recruitment of structurally normal fetuses with either known growth restriction or with maternal complications such as hypertension or diabetes will be included.

Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria: Pregnancies where the dating of the pregnancy is uncertain.
Pregnancies where structural abnormality has been noted on the fetal morphology scan.
Pregnancies where there is an inability to gain full written consent for participation.


Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study will use a combination of quantitative statistical analysis and quantitative data evaluation. Quantitative statistical analysis will be performed using SPSS version 22.0 (SPSS Inc., Chicago, IL, USA). Evaluation will be undertaken in keeping with the Study Objectives.

Acceptability for both healthcare participants and healthcare practitioner will be evaluated using a mixed methods framework, with data collected via purpose-designed questionnaires.
For participants these will be offered by the sonographer immediately following the ultrasound, with the option to complete there or return later. If the participant takes the questionnaire home to complete, the site PI will follow up with the participant after their visit to obtain the questionnaire once completed.
For healthcare practitioners they will be offered once during the lifetime of the project at their institution (a broad selection of those involved in maternity care for clients who are involved in this study will be included and not just those undertaking the scans). Likert scales and free text will be used for this evaluation. Questionnaires will take around 10-20 minutes for those who speak and read in English, for those requiring assistance by a midwife or cultural liaison, it may take up to one hour.

Questionnaire data will be initially be uploaded to be analysed through the UNSW Qualtrics data repository then the data will be exported into the IBM SPSS statistics software. The open text responses will be loaded into NVivo 14 qualitative data manipulation software and analysed using an interpretive approach as outlined by Elbarden et al 2017. (Elbardan H, Kholeif AOR. An Interpretive Approach for Data Collection and Analysis. Springer International Publishing; 2017. p. 111-65.).
Coding will be used to arrange and conceptualise the responses into themes to allow for further analysis.

Performance of the Imaging Chain will be evaluated in the form of descriptive data for percentage success and time taken at each point from image acquisition through to cloud transfer, cloud analysis, transmission of result back to machine and result viewing.
Performance of 3D-FMBV novel indices for identification of risk will be evaluated using logistic regression analysis for data analysis, coupled with receiver operating characteristic curve analysis to determine thresholds for risk. In addition, machine learning techniques for dimension reduction will be applied to this data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/08/2025
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
25
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 28336 0
Kingaroy Hospital & Community Health Centre - Kingaroy
Recruitment postcode(s) [1] 44549 0
4610 - Kingaroy

Funding & Sponsors
Funding source category [1] 319719 0
Charities/Societies/Foundations
Name [1] 319719 0
Wellcome Leap In Utero
Country [1] 319719 0
United States of America
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 322227 0
None
Name [1] 322227 0
Address [1] 322227 0
Country [1] 322227 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318272 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 318272 0
Ethics committee country [1] 318272 0
Australia
Date submitted for ethics approval [1] 318272 0
04/02/2025
Approval date [1] 318272 0
14/03/2025
Ethics approval number [1] 318272 0
ETHoo238

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

Contacts
Principal investigator
Name 143662 0
Prof Alec Welsh
Address 143662 0
Division of Women's Health, Level 0, Royal Hospital for Women, Barker Street, Randwick, NSW 2031
Country 143662 0
Australia
Phone 143662 0
+61423980994
Fax 143662 0
Email 143662 0
[email protected]
Contact person for public queries
Name 143663 0
Noelle Simpson
Address 143663 0
Division of Women's Health, Level 0, Royal Hospital for Women, Barker Street, Randwick, NSW 2031
Country 143663 0
Australia
Phone 143663 0
+61293826098
Fax 143663 0
Email 143663 0
[email protected]
Contact person for scientific queries
Name 143664 0
Alec Welsh
Address 143664 0
Division of Women's Health, Level 0, Royal Hospital for Women, Barker Street, Randwick, NSW 2031
Country 143664 0
Australia
Phone 143664 0
+61293826098
Fax 143664 0
Email 143664 0
[email protected]

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


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    2025_ETH00238 - Protocol v6 -Clean.docx


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.