Status:
NOT_YET_RECRUITING
Femom System Compared to the Standard of Care CTG
Lead Sponsor:
Biorithm Pte Ltd
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18-50 years
Brief Summary
The goal of this observational study is to evaluate the safety and performance of the femom system compared to the standard of care CTG for antepartum fetal monitoring in pregnant women with singleton...
Eligibility Criteria
Inclusion
- Female age between 18-50-year-old
- Singleton pregnancy.
- Should be at and above 32+0 weeks of pregnancy.
- Able to speak and read English to understand and sign the Informed Consent.
Exclusion
- Participants with an intellectual or mental impairment.
- Participants with a known allergy or hypersensitivity to ECG gel electrodes.
- Known fetal cardiac or genetic abnormality.
- Clinically unstable participants who require immediate medical care.
- Participants 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.
- Participants with implantable electronic devices such as pacemaker or ICD.
- Participants with medical skin condition in the abdominal area (such as wounds, cuts in the skin, skin rash, etc.)
Key Trial Info
Start Date :
July 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06490471
Start Date
July 1 2024
End Date
July 1 2025
Last Update
July 8 2024
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