Validation of Sensors for Long-term Non-Invasive Fetal Monitoring

A multidisciplinary team of a doctor and engineers have developed a new sensor that will be able to detect mothers' and babies' heartbeat and babies movements in late pregnancy. This sensor can be placed in contact with the mothers' skin over the pregnant uterus without having to be stuck down. We anticipate that this sensor would allow us to monitor babies for longer periods of time which might help us to better identify babies who are being deprived of oxygen during pregnancy. We need to test these sensors on women in late pregnancy for two reasons. Firstly, we need to ensure they reliably measure mother and babies heart rates without interference from movement or other electrical equipment. Secondly we need to ensure that the information they provide is accurate (compared to current measurement techniques). We will carry out two related studies. The first will include up to 24 women to develop the sensors to ensure that they can obtain consistent signals from mothers' and babies' heartbeats without interference from movement and other electronic devices. We will adjust the electronics in the sensors to ensure they give the best signal. The second will include up to 45 women to see whether the information detected by the sensors is comparable to existing technologies. This information will help us to see whether these sensors can be organised into a new device for fetal monitoring which can then be tested.

NCT Number	NCT06952777
Lead Sponsor	University of Manchester
Conditions	Fetal Distress With Antenatal Problem, Fetal Growth Retardation
Enrollment	69 participants
Start Date	2024-06-01
Primary Completion	2025-12-31 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-01