UPatch
Research type
Research Study
Full title
Feasibility and development of novel wearable sensors to monitor blood flow to the baby in utero
IRAS ID
321223
Contact name
Antoniya Georgieva
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
Stillbirth is defined as a fetal death after 24 weeks of pregnancy, before or during birth. As many as 60% of stillbirths are considered unexplained. Currently, it is known that consistent antenatal care, screening tools for pre-eclampsia and gestational diabetes, as well as cardiotocography (monitoring the babies’ heart rate) and ultrasound scans, can reduce the risk of stillbirth and fetal brain injury in pregnancy. Although valuable screening tools, their success depends on multiple factors such as their correct and timely use and access to often expensive equipment or hospital facilities.
Ultrasound technology is widely used in pregnancy and allows medical practitioners to see how well a baby is doing in utero and detect any signs of poor health. Altered blood flow to the baby can be a warning sign for stillbirth or brain damage before birth. To date, a lack of technological advances has meant that we are only able to perform ultrasounds with usually large and expensive machines providing a single measurement, and not allowing continuous observations to monitor changes to the blood pressure or blood flow of the baby or placenta/cord.
A collaborating academic team at the Engineering Department of the University of California San Diego (UCSD) have been researching an innovative tool that uses standard ultrasound technology embedded in a small wearable and cost-effective Ultrasound Patch, UPatch. It has been used to measure blood pressure non-invasively in cardiac patients in the USA, and now our project at Oxford will study whether it is possible to modify the UPatch and re-design it to allow continuous blood flow monitoring in utero (cord, placenta and fetus).
This study has been discussed with MHRA who have confirmed that this is not a clinical investigation of a medical device needing notification to them.
REC name
Wales REC 4
REC reference
23/WA/0032
Date of REC Opinion
8 Feb 2023
REC opinion
Favourable Opinion