Status:
RECRUITING
Validation of Sensors for Long-term Non-Invasive Fetal Monitoring
Lead Sponsor:
University of Manchester
Conditions:
Fetal Distress With Antenatal Problem
Fetal Growth Retardation
Eligibility:
FEMALE
16-50 years
Phase:
NA
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 pla...
Detailed Description
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 bac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT06952777
Start Date
June 1 2024
End Date
December 31 2025
Last Update
May 1 2025
Active Locations (1)
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1
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL