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

NCT06952777 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2025-05-01

No results posted yet for this study

Summary

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.

Conditions

  • Fetal Distress With Antenatal Problem
  • Fetal Growth Retardation

Interventions

OTHER

Non-adhesive capacitively-coupled sensors

Non-adhesive capacitively-coupled sensors which can detect signals of the magnitude of the fetal heart rate and information about fetal movements.

Sponsors & Collaborators

  • University of Manchester

    lead OTHER

Principal Investigators

  • Alexander Heazell, PhD · University of Manchester

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06952777 on ClinicalTrials.gov