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NCT06952777

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

Recruiting now NA Last updated 1 May 2025
What this trial tests

NA trial testing Non-adhesive capacitively-coupled sensors in Fetal Distress With Antenatal Problem in 69 participants. Currently enrolling.

Timeline
1 June 2024
Primary endpoint
31 December 2025
31 December 2025

Quick facts

Lead sponsorUniversity of Manchester
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment69
Start date1 June 2024
Primary completion31 December 2025
Estimated completion31 December 2025
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University of Manchester

Who can join

Adults 16 to 50, female only, with Fetal Distress With Antenatal Problem or Fetal Growth Retardation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Trials by the same sponsor.

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Data sources for this page

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