Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000394448
Ethics application status
Approved
Date submitted
9/04/2025
Date registered
1/05/2025
Date last updated
1/05/2025
Date data sharing statement initially provided
1/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a new ultrasound system to measure blood flow in babies in the womb to compare it with existing ultrasound machines.
Scientific title
Equivalence testing of tissue perfusion values in pregnancy derived from a novel purpose-designed ultrasound perfusion system compared to those values coming from a commercially available ultrasound system
Secondary ID [1] 314170 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fetal tissue perfusion 337128 0
fetal wellbeing 337025 0
Condition category
Condition code
Reproductive Health and Childbirth 333475 333475 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 333476 333476 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We have developed a purpose-designed low-cost ultrasound machine to measure tissue perfusion using the technique Fractional Moving Blood Volume (FMBV). This system has been constructed using commercially available ('off-the-shelf') ultrasound componentry (ultrasound board from Telemed and probe from Noraysu), fabricated under full ISO 13485 and IEC 62304 regulatory compliance standards.
The purpose-designed machine has been specifically designed to be low-cost, to have automated settings for more accurate perfusion measurement, and to have the ability to transfer ultrasound volumes for cloud-based software analysis. Other features of the machine (transducer type, power output etc are in keeping with conventional commercial ultrasound machines.
We wish to test our purpose designed ultrasound machine (the ‘local’ machine) against the existing commercial machinery used to establish our normal ranges for fetoplacental perfusion (the GE Voluson E10 system).
This study aims to evaluate performance of our local machine against the GE E10 using a mixed population cohort of ‘low-’ and ‘high-’ risk pregnancies. We wish to determine whether the results for 3D-FMBV perfusion evaluation (as a percentage 3D-FMBV) are equivalent to those from the GE or if the results require some form of scaling factor to be applied.
Participants will be scanned using both the GE ultrasound machine and our purpose-designed system allowing direct comparison of values for fetal organ perfusion from the two machines. This will then tell us whether the new machine gives repeatable measurements, and if these are the same as the GE machine (as paired comparisons can be made within the same participants).
It is anticipated that following routine evaluation of fetal wellbeing with the GE ultrasound machine (taking approximately 10-15 minutes, ultrasound volumes will be stored of fetal perfusion to the kidney, brain, liver and placenta. We anticipate approximately 10 minutes for ultrasound volume storage for each machine.
Once these volumes of 3D ultrasound are stored, the patient will not be involved further in calculation of FMBV. This calculation will be undertaken on de-identified volumes on a desktop computer at a later time point.
Sonographers or obstetricians with subspecialist training will undertake the scans. No additional training will be required for these participants to use the machine (as they have been involved in its development).
There will be no difference in assessment for those cases determined to be 'low-risk' versus 'high-risk' as the study involves comparison of absolute values for fetal organ and placental perfusion in structurally normal fetuses.
Intervention code [1] 330773 0
Early Detection / Screening
Comparator / control treatment
No control group as there will be paired comparisons.
The GE E10 system is the 'industry standard' machine used in obstetrics and fetal medicine imaging and is the one used by most such departments in Australia.
The novel system has been designed using a purpose-specific ultrasound control board (the ArtUS system from Telemed) that is commercially available as an ultrasound controller. This is coupled with a probe manufactured by Noraysu that is commercially available.
Participants will have a single scan visit. Following routine evaluation of fetal wellbeing (standard biometry, amniotic fluid volume and Dopplers), triplicated ultrasound volumes will be stored from the fetal brain, liver, kidney and placenta (5-6 placental volumes in total) using first the GE machine and then the purpose-designed ultrasound system.
The ultrasound will be conducted by a sonographer with over 2 decades of experience in maternity scanning, or a subspecialist in maternal-fetal medicine with over 2 decades of specialist MFM scanning experience.
Control group
Active

Outcomes
Primary outcome [1] 341053 0
Perfusion values for the fetal brain, liver, kidney and placenta. The mean absolute values for each as determined using the calculation Fractional Moving Blood Volume will be compared between the purpose-designed machine and the current commercial machinery (GE). This will be evaluated as a composite outcome.
Timepoint [1] 341053 0
Single timepoint for comparative evaluation per case.
Secondary outcome [1] 445969 0
Repeatability / stability of measurement with the new machine will be evaluated by taking triplicated ultrasound volumes from each organ. This will show whether the results taken from the new machine are as consistent as those available from the commercial machinery.
Timepoint [1] 445969 0
Static timepoint: comparison of single timepoint for examination with established ranges for the measure FMBV.

Eligibility
Key inclusion criteria
Patients over 18 years of age with the ability to comprehend and consent to a research study, with planned birth at RHW facilitating acquisition of outcome data.
For 'low-risk' cases and 'high-risk' cases we will use criteria used for our recent projects used to establish FMBV normal ranges i.e. absence of complicating factors such as growth restriction, diabetes, hypertension etc. However, for this study, 'low-risk' and 'high-risk' cases are not of great relevance as we simply aim to compare absolute values for FMBV.

Inclusion criteria for 'low-risk for our recent normal range study (from the approved protocol) were:

"The study will include women carrying singleton fetuses; gestational age between 28- and 42-weeks gestation, determined by the last menstrual period and confirmed by first trimester ultrasound; normal fetus on morphology scan; no complications noted on further sonography if undertaken, including intrauterine growth restriction."
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to comprehend e.g. insufficient comprehension of English, or comprehension of recruitment material.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27735 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 43925 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 318686 0
Charities/Societies/Foundations
Name [1] 318686 0
Wellcome Leap
Country [1] 318686 0
United States of America
Primary sponsor type
University
Name
UNSW Sydney
Address
Country
Australia
Secondary sponsor category [1] 321112 0
Hospital
Name [1] 321112 0
Royal Hospital for Women
Address [1] 321112 0
Country [1] 321112 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317296 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 317296 0
Ethics committee country [1] 317296 0
Australia
Date submitted for ethics approval [1] 317296 0
23/01/2025
Approval date [1] 317296 0
18/03/2025
Ethics approval number [1] 317296 0

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

Contacts
Principal investigator
Name 140602 0
Prof Alec Welsh
Address 140602 0
Division of Women's Health, Level 0, Royal Hospital for Women, Barker Street, Randwick, NSW 2031
Country 140602 0
Australia
Phone 140602 0
+61 2 9382 6098
Fax 140602 0
Email 140602 0
[email protected]
Contact person for public queries
Name 140603 0
Ms Noelle Simpson
Address 140603 0
Division of Women's Health, Level 0, Royal Hospital for Women, Barker Street, Randwick, NSW 2031.
Country 140603 0
Australia
Phone 140603 0
+61 2 9382 6098
Fax 140603 0
Email 140603 0
[email protected]
Contact person for scientific queries
Name 140604 0
Alec Welsh
Address 140604 0
Division of Women's Health, Level 0, Royal Hospital for Women, Barker Street, Randwick, NSW 2031.
Country 140604 0
Australia
Phone 140604 0
+61 2 9382 6098
Fax 140604 0
Email 140604 0
[email protected]

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


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    2025_ETH00025_ Application HREA - Approve.pdf


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.