Status:
RECRUITING
AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies
Lead Sponsor:
Biorithm Pte Ltd
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18-50 years
Brief Summary
This study is a planned research project to test and demonstrate the feasibility of using the Femom device for monitoring fetal heart rate remotely. The main goal is to learn if the remote recordings...
Detailed Description
The Femom device is a non-invasive fetal ECG (NIFECG) device which has been developed for self application and remote monitoring. Women from three different cohort groups (controls, FGR and insulin de...
Eligibility Criteria
Inclusion
- Singleton live pregnancy
- \> 26 weeks gestational age
- Able to speak English or available NHS interpreter
Exclusion
- Women below 18 years of age
- Women with an intellectual or mental impairment
- Women with a known allergy or hypersensitivity to ECG gel electrodes
- Known fetal cardiac or genetic abnormality.
- Patient with existing dependent or unequal relationships with any member of the research team, the researchers(s) and/or the person undertaking the recruitment/consent process.
- Inability to access interpreter.
Key Trial Info
Start Date :
March 19 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06497205
Start Date
March 19 2024
End Date
August 31 2025
Last Update
July 11 2024
Active Locations (1)
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1
St Georges University Hospital
London, Tooting, United Kingdom, SW17 0QT