NCT06497205 AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies
| NCT ID | NCT06497205 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biorithm Pte Ltd |
| Condition | Pregnancy Related |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-03-19 |
| Primary Completion | 2025-04-30 |
Trial Parameters
Eligibility Fast-Check
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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 using Femom provide reliable information about the baby's heart rate. We will also establish reference standards of heart rate variability in uncomplicated pregnancies at different stages of pregnancy. Additionally, we will compare the heart rate variability in FGR and diabetic pregnancies to normal pregnancies.
Eligibility 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.