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
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.
Summary of Results
Around the world, a baby is stillborn every 16 seconds, and the effects of baby loss in this way on the mother and family can be devastating with both emotional and financial impacts. This research study aimed to find better tests that can predict when an unborn baby might be at risk of dying in the mother's womb after 24 weeks of pregnancy.
This study looked at whether a new monitoring device known as UPatch was able to monitor the baby's health continuously and without the need of a clinician to operate it. Current methods used to monitor a baby only provide a snapshot using an ultrasound scan of the baby, taken by a trained clinician.
The research team were also looking to see whether this device, which attaches to the mother's tummy could be used for a number of hours. Researchers wanted to know if it could provide valuable information over a period of time to doctors, while also being comfortable for the mother to wear on her tummy.
This UK-based aspect of the study took place at the John Radcliffe Hospital in Oxford. We are grateful to all the participants who agreed to take part and help us with this research and to the members of our Patient and Public Involvement (PPI) panel https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.wrh.ox.ac.uk%252Fresearch%252Foxfordlabourmonitoringgroup%2FNBTI%2FE1q7AQ%2FAQ%2F6e6c3ff0-ffcd-4ad6-966d-736be2633a7a%2F1%2FSi7i9xPVY8&data=05%7C02%7CWales.REC4%40wales.nhs.uk%7C9e415ad731cd49b21c0808dd556a4699%7Cbb5628b8e3284082a856433c9edc8fae%7C0%7C0%7C638760637160848573%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=l8%2FynbBDC5wN5MOK5V67N%2FLqDiPy7Tb57%2BuTvdmjtsg%3D&reserved=0 who took the time to review our patient-facing information.
Who took part in the study? The study recruited 63 pregnant participants, all of whom were between 24 and 42 weeks pregnant. Participants were either going to hospital for antenatal appointments or they were staying in hospital for a medical reason that wasn't related to this study.
People who took part were asked to wear the UPatch for between 5 mins and 4 hours while the research team monitored the results and collected valuable information. We used computers to analyse the relevant signal and images which were generated by the software the UPatch uses.
This study was designed only to observe if and how the device worked, as we were keen to collect information for its further development. The clinical care of participants in this study was not affected in anyway as a result of their taking part.
What medical problems did the participants have? One participant who was monitored with the UPatch device placed on different areas of her tummy for up to 3 hours, experienced some redness of the skin and one area had developed into a small blister by the following day. The patient reported no pain at any point during these two days, and was observed by a doctor but did not need medical treatment.
There were no other medical problems or adverse reactions from the people who took part in this study.
What were the results of the study? The study results have been summarised and included in an academic paper which has been sent to a research publication for review by academics not associated with the study. Once the paper is published the public will be able to read the results online.
How has this study helped patients and researchers?
This study allowed our team to prove that the concept behind the development of the UPatch device as well as its design works. It has provided useful information which will help further development of the associated software the UPatch uses for image analysis. In the long run, UPatch is quite likely to revolutionise the field of fetal monitoring before and during labour. This could lead to new knowledge about the healthy development of babies during pregnancy, as well as helping prevent stillbirth and injury of the fetus in the womb.
Details of any further research planned
Our device is currently undergoing further technical developments to ensure it is robust, portable and has the necessary regulatory approvals to be used commercially/in the real world, outside research.REC name
Wales REC 4
REC reference
23/WA/0032
Date of REC Opinion
8 Feb 2023
REC opinion
Favourable Opinion