Femom System Compared to the Standard of Care CTG

Launched by BIORITHM PTE LTD · Jul 4, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new device called the femom system, which is used for monitoring the health of babies before birth, specifically in pregnancies that are over 32 weeks. The purpose of the study is to see how well the femom device works compared to the standard method currently used, known as CTG (Cardiotocography). Researchers want to find out if the information gathered by the femom device about the baby's heart rate and other important measures matches what is recorded by the traditional CTG method. They also want to see how easy it is for doctors to interpret the data from both devices.

To participate in this study, women aged 18 to 50 who are pregnant with one baby and at least 32 weeks along may be eligible. Participants will have both the femom device and the CTG equipment attached to their belly for about 30 minutes while they undergo a test called a non-stress test (NST). It's important to note that some women may not qualify if they have certain health conditions or issues with their skin in the abdominal area. The study is not yet recruiting participants, but it aims to gather important information about the safety and effectiveness of the femom system in monitoring fetal health.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Female age between 18-50-year-old
• • 2. Singleton pregnancy.
• • 3. Should be at and above 32+0 weeks of pregnancy.
• • 4. Able to speak and read English to understand and sign the Informed Consent.
• Exclusion Criteria:
• • 1. Participants with an intellectual or mental impairment.
• • 2. Participants with a known allergy or hypersensitivity to ECG gel electrodes.
• • 3. Known fetal cardiac or genetic abnormality.
• • 4. Clinically unstable participants who require immediate medical care.
• • 5. 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.
• • 6. Participants with implantable electronic devices such as pacemaker or ICD.
• • 7. Participants with medical skin condition in the abdominal area (such as wounds, cuts in the skin, skin rash, etc.)