Remote monitoring of fetal heart rate in pregnancies
AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies
This study is testing a new device that allows pregnant women to monitor their baby's heart rate at home to see if it works well for both low and high-risk pregnancies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Biorithm Pte Ltd Industry-sponsored |
| Locations | 1 site (London, Tooting) |
| Trial ID | NCT06497205 on ClinicalTrials.gov |
What this trial studies
This research project aims to evaluate the feasibility of the Femom device for remote monitoring of fetal heart rate in low and high-risk pregnancies. Participants will include women from three groups: controls, those with fetal growth restriction (FGR), and insulin-dependent diabetes. Each group will monitor their baby's heart rate at home for specified durations, and data will be collected to assess compliance, signal quality, and establish reference standards for heart rate variability. The study will also gather feedback on the usability of the device to determine the practicality of home antenatal monitoring.
Who should consider this trial
Good fit: Ideal candidates include women with singleton pregnancies over 26 weeks gestational age who can communicate in English or have access to an interpreter.
Not a fit: Patients who may not benefit include those under 18 years of age, those with mental impairments, known fetal abnormalities, or allergies to ECG gel electrodes.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for remote fetal monitoring, enhancing prenatal care and potentially improving pregnancy outcomes.
How similar studies have performed: While the approach of remote fetal monitoring is gaining traction, this specific application of the Femom device is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Singleton live pregnancy * \> 26 weeks gestational age * Able to speak English or available NHS interpreter Exclusion Criteria: * 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.
Where this trial is running
London, Tooting
- St Georges University Hospital — London, Tooting, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Amarnath Bhide, MBBS, PHD — St Georges University Hospitals
- Study coordinator: Vilasini Nair
- Email: vilanair@bio-rithm.com
- Phone: +659628109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.