NCT06952777 Validation of Sensors for Long-term Non-Invasive Fetal Monitoring
| NCT ID | NCT06952777 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Manchester |
| Condition | Fetal Distress With Antenatal Problem |
| Study Type | INTERVENTIONAL |
| Enrollment | 69 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 69 participants in total. It began in 2024-06-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Participants will be included if they have a non-anomalous singleton pregnancy after 28 weeks' gestation with an estimated fetal weight \>10th centile \< 90th centile. Participants will be 16 years or over in order that they can give independent consent. Exclusion Criteria: * Participants will be excluded if there are fetal anomalies (as defined by the NHS Fetal Anomaly Screening Programme - https://www.gov.uk/guidance/fetal-anomaly-screening-programme-overview), it is a multiple pregnancy, there is evidence of Fetal Growth Restriction (Estimated Fetal Weight \<10th centile) or if participants cannot speak or do not understand fluent English. Participants will not be able to participate if they are unable to give informed consent. Participants \<16 years of age will be excluded from this study.
Contact & Investigator
Alexander Heazell, PhD
PRINCIPAL INVESTIGATOR
University of Manchester
Frequently Asked Questions
Who can join the NCT06952777 clinical trial?
This trial is open to female participants only, aged 16 Years or older, up to 50 Years, studying Fetal Distress With Antenatal Problem. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06952777 currently recruiting?
Yes, NCT06952777 is actively recruiting participants. Contact the research team at alexander.heazell@manchester.ac.uk for enrollment information.
Where is the NCT06952777 trial being conducted?
This trial is being conducted at Manchester, United Kingdom.
Who is sponsoring the NCT06952777 clinical trial?
NCT06952777 is sponsored by University of Manchester. The principal investigator is Alexander Heazell, PhD at University of Manchester. The trial plans to enroll 69 participants.