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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.
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 dependent diabetes) will be approached and asked to monitor their baby at home once a day. Women in the control group will be asked to do this once a day for one week, the FGR pregnancies until delivery and the insulin dependent diabetics just from 36 weeks until delivery.
The data will be collected and analysed retrospectively to assess compliance of the participants with the study protocol, signal quality and establish reference standards in relation to gestation within the control group. Heart rate variability measures in the FGR and diabetes arm will be compared to the reference standards in the control group. Outcomes of the pregnancy.
Feedback regarding the usability of the device will also be collected using a feedback questionnaire to assess the feasibility of home antenatal monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | low risk ASPRE | ||
| FGR Group | FGR according to definition of ISUOG | ||
| Diabetic Group | insulin dependent diabetes |
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| Measure | Description | Time Frame |
|---|---|---|
| FHR | FHR agreement between Femom system and standard of care (CTG) | 60 minutes |
| MHR | MHR agreement between Femom system and standard of care (CTG) | 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Women booked for antenatal care at St. George's hospital or women under the care of the Fetal medicine unit at St. George's hospital will be invited to participate in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vilasini Nair | Contact | +659628109 | vilanair@bio-rithm.com |
| Name | Affiliation | Role |
|---|---|---|
| Amarnath Bhide, MBBS, PHD | St Georges University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Georges University Hospital | Recruiting | London | Tooting | SW17 0QT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41022451 | Derived | Pegorie C, Liu B, Thilaganathan B, Bhide A. Ambulatory foetal ECG monitoring in low and high-risk pregnancies (AMBER2): a prospective cohort study protocol. BMJ Open. 2025 Sep 28;15(9):e096123. doi: 10.1136/bmjopen-2024-096123. |
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