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

Recruiting now · Not applicable

Conditions studied: Fetal Distress With Antenatal Problem, Fetal Growth Retardation

In brief

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.

Key facts

Study ID: NCT06952777
Run by: University of Manchester
People needed: 69
Starts: 2024-06-01
Expected to finish: 2025-12-31
Last updated by the study team: 2025-05-01

Who can join

Age: 16 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Participants will be included if they have a non-anomalous singleton pregnancy after 28 weeks' gestation with an estimated fetal weight >10th centile < 90th centile. Participants will be 16 years or over in order that they can give independent consent.

You may not qualify if…

Participants will be excluded if there are fetal anomalies (as defined by the NHS Fetal Anomaly Screening Programme - https://www.gov.uk/guidance/fetal-anomaly-screening-programme-overview), it is a multiple pregnancy, there is evidence of Fetal Growth Restriction (Estimated Fetal Weight <10th centile) or if participants cannot speak or do not understand fluent English. Participants will not be able to participate if they are unable to give informed consent. Participants <16 years of age will be excluded from this study.

Where it is running

Manchester University NHS Foundation Trust — Manchester, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.