An interventional study of Non-adhesive capacitively-coupled sensors in Fetal Distress With Antenatal Problem and Fetal Growth Retardation, sponsored by University of Manchester. Recruiting at 1 site in United Kingdom. Open to female participants aged 16 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by University of Manchester · Not applicable, Interventional, and Other
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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.
In the first part of the study we will ask up to 24 pregnant women to wear the non adhesive sensors and determine whether they consistently detect the electronic signals and to reduce recording of background electrical noise e.g. from electrical wires / devices / sockets etc. which are likely to emit electrical activity in the same microvolt range as the fetal heart rate trace.
Participants will be from three separate time periods in late pregnancy (8 women in each time frame) 28+0-31+6 weeks, 32+0-35+6 weeks and finally from 36+0 until 40+0 weeks. Women will be recruited from the Tommy's research clinics and the antenatal clinics at St Mary's Hospital, Manchester. All participants will have an ultrasound scan prior to participation to measure baby's size, the liquor volume and umbilical artery Doppler (all indicators of baby's wellbeing).
This will ensure that baby is well before the sensors are used. If needed we will make adaptations to the electronics to optimise the detection of the mother's and baby's heart rate.
Participants will be asked to lie on an examination couch for up to 60 minutes at 45 degrees while the electronic sensor(s) are gently held in contact with the maternal abdomen by an elastic belt. If participants are uncomfortable they will be able to sit or stand to relieve their discomfort. Basic information including body mass index, stage of pregnancy and estimated fetal weight will be recorded on a proforma.
If consistent signals can be obtained we will assess whether the sensors can accurately display maternal heart rate and fetal heart rate at different stages of late pregnancy. To assess whether the recording is accurate we will compare the output from the sensors with current methods to assess maternal heart rate (ECG), fetal heart rate (MONICA24).
We will use ultrasound scan to assess whether fetal movements are associated with expected changes in fetal heart activity.
To assess sensor reliability we will recruit up to 15 women from each gestational age group from 28+0-31+6 weeks, 32+0-35+6 weeks and finally from 36+0 until 40+0 weeks. Women will be approached if they have healthy singleton pregnancies and have a pre-pregnancy BMI from 20-35. As previously, women will be recruited from the Tommy's research clinics and the antenatal clinics at St Mary's Hospital, Manchester. The correlation between the maternal and fetal heart rates obtained using established techniques and the new sensors will be calculated.
Participants will be asked to complete a short baseline questionnaire before commencing the monitoring process. Participants will be asked to lie on an examination couch for up to 60 minutes at 45 degrees while the electronic sensor(s) are gently held in contact with the maternal abdomen by an elastic belt. In addition to the new sensors the fetal and maternal heart rate will be recorded using the MONICA AN24 device and fetal movements will be recorded with ultrasound (for 20 minutes of the 60). If participants are uncomfortable they will be able to sit or stand to relieve their discomfort. Basic information including body mass index, stage of pregnancy and estimated fetal weight will be recorded on a proforma. In addition, participants will be asked to complete a questionnaire about anxiety and wearing the device after the monitoring process.
262 studies on the registry are indexed under Fetal Growth Retardation; 69 are open to participants now.
This study's planned enrollment of 69 is below the median of 150 across 110 interventional studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →University of Manchester is the lead sponsor of 201 studies on the registry; 44 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be asked to complete a short baseline questionnaire before commencing the monitoring process. Participants will be asked to lie on an examination couch for up to 60 minutes at 45 degrees while the electronic sensor(s) are gently held in contact with the maternal abdomen by an elastic belt. In addition to the new sensors the fetal and maternal heart rate will be recorded using the MONICA AN24 device and fetal movements will be recorded with ultrasound (for 20 minutes of the 60). If participants are uncomfortable they will be able to sit or stand to relieve their discomfort. Basic information including body mass index, stage of pregnancy and estimated fetal weight will be recorded on a proforma. In addition, participants will be asked to complete a questionnaire about anxiety and wearing the device after the monitoring process.
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.
Recording quality of non-adherent sensors
Proportion of recording time that non-adherent sensors record fetal heart rate
Time frame: 0-60 minutes recording during
Maternal comfort
Self-reported comfort of wearing the non-adherent sensors using Likert Scale
Time frame: Immediately after the recording period
Maternal anxiety
Completion of state trait anxiety index
Time frame: Immediately prior to or after the recording period
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There is no plan to share individual participant data after this initial preclinical study.
Started Jun 2024 (actual). Primary completion is estimated for Dec 2025, 18 months after the start.
Of 39 non-industry interventional studies with no phase under Fetal Growth Retardation, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 52. This study's planned 18 months is below that.
Counting every sponsor, half of 40 studies reached it within 35 months; a quarter within 18 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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