Actively Recruiting
Measurement and Validation of Fetal Heart and Fetal Movement Signals Detected Via Non-adhesive Sensors for Monitoring in Late Pregnancy
Led by University of Manchester · Updated on 2025-05-01
69
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new type of non-adhesive sensor designed to detect both mothers' and babies' heartbeats and fetal movements during late pregnancy. The study aims to see if these sensors can monitor babies for longer periods and provide accurate information compared to current methods. This research involves women with healthy singleton pregnancies to ensure the sensors can reliably detect signals without interference and provide accurate data on fetal wellbeing. The study includes two parts: first, up to 24 pregnant women will wear the sensors at different late pregnancy stages (28+0 to 40+0 weeks) to optimize signal detection and reduce background noise. The sensors are gently held on the mother's abdomen using an elastic belt while participants lie or sit for up to 60 minutes. In the second part, up to 45 women will have their heart rates and fetal movements recorded using both the new sensors and established devices like the MONICA AN24 and ultrasound to compare accuracy. Participants will complete questionnaires about anxiety and comfort related to wearing the sensors. Basic information such as body mass index, pregnancy stage, and estimated fetal weight will be recorded. The primary outcome is the quality of the sensor recordings over 60 minutes, with secondary measures including maternal comfort and anxiety. The study is expected to last until the end of 2025, with participation involving a single monitoring session lasting about an hour.
CONDITIONS
Brief Title
Validation of Sensors for Long-term Non-Invasive Fetal Monitoring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with a non-anomalous singleton pregnancy after 28 weeks' gestation
- Estimated fetal weight between the 10th and 90th percentile
- Participants aged 16 years or older able to give independent consent
You will not qualify if you...
- Presence of fetal anomalies as defined by the NHS Fetal Anomaly Screening Programme
- Multiple pregnancy (twins or more)
- Evidence of fetal growth restriction (estimated fetal weight below the 10th percentile)
- Inability to speak or understand fluent English
- Participants under 16 years of age or unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for ultrasound and initial assessments
Duration - Up to 60 minutes per monitoring session
Participants wear non-adhesive sensors to detect fetal heart rate and movements while lying on an examination couch or sitting/standing if uncomfortable. Maternal and fetal heart rates are also recorded using established devices, and fetal movements are assessed with ultrasound.
1 monitoring visit (in-person)
Trial Site Locations
Total: 1 location
1
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Actively Recruiting
Research Team
A
Alexander Heazell, PhD
E
Emma Tomlinson, RM
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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