Actively Recruiting

Phase Not Applicable
Age: 16Years - 50Years
FEMALE
Healthy Volunteers
NCT06952777

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

Led by University of Manchester · Updated on 2025-05-01

69

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 16Years - 50Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Non-anomalous singleton pregnancy after 28 weeks' gestation
  • Estimated fetal weight between 10th and 90th percentile
  • Participant is 16 years or older and can give independent consent
Not Eligible

You will not qualify if you...

  • Presence of fetal anomalies as defined by NHS Fetal Anomaly Screening Programme
  • Multiple pregnancy (twins or more)
  • Evidence of fetal growth restriction (estimated fetal weight below 10th percentile)
  • Inability to speak or understand fluent English
  • Participants unable to give informed consent
  • Age under 16 years

AI-Screening

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Trial Site Locations

Total: 1 location

1

Manchester University NHS Foundation Trust

Manchester, United Kingdom, M13 9WL

Actively Recruiting

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Research Team

A

Alexander Heazell, PhD

CONTACT

E

Emma Tomlinson, RM

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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