None listed
Conditions
Brief summary
Our research team evaluates fetoplacental perfusion using ultrasound and a validated ultrasound imaging tool called Three-Dimensional Fractional Moving Blood Volume (3D-FMBV). Previous experimental work from our group has shown an excellent correlation between 3D-FMBV and accepted ‘gold-standard’ measurements of blood flow. Funding from the Wellcome Leap In Utero (WLIU) project (https://wellcomeleap.org/inutero/) has allowed us to determine normal ranges for fetal organ perfusion (brain, liver and kidney) and placental perfusion. The WLIU project funded production in 2023-2024 of a purpose-designed low-cost ultrasound system though an independent design and engineering consultancy (IDE Group). This was constructed based upon original equipment manufacturer components under full ISO13485 and IEC 62304 regulatory compliance. We will be undertaking an equivalence study in early 2025 to show that our ultrasound machine measures perfusion in a comparable manner to the previously used GE machine. The goal of the Wellcome Leap In Utero research is to develop a low-cost tool for late pregnancy evaluation to determine the fetus ‘at risk’, that can be used in low resource environments. We wish to undertake a study to look at feasibility and acceptability of our ultrasound device and its predictive ability for stillbirth or hypoxic fetal compromise in a high-risk population. Discussions with participants in high-risk priority populations (including Aboriginal and Torres Strait Islander peoples) located in three identified rural/remote centres have identified the urgent need for predictive markers for late pregnancy loss. Our team of clinicians and engineers will work with our collaborators in these priority populations to collect relevant markers (individual fetal organ perfusion or ratios) and validate these against our established normal ranges.
Interventions
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 l
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.
Sponsors
University of New South Wales
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed