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This clinical study will evaluate the safety and comparative performance of Biorithm Research Kit vs CTG (gold standard) in prenatal monitoring of pregnant participants.
The Biorithm Research Kit system used in this study consists of femom fetal monitor (known as fetal monitor), a digital gateway and a cloud storage. It's intended for monitoring of maternal and fetal physiological parameters. It includes non-invasive fetal monitor or device, that monitors fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA) in the antepartum period.
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| Measure | Description | Time Frame |
|---|---|---|
| Fetal Heart Rate (FHR) | FHR agreement between Biorithm Research Kit and standard of care (CTG) | 60 minutes |
| Maternal Heart Rate (MHR) | MHR agreement between Biorithm Research Kit and standard of care (CTG) | 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Participants would be recruited at the Day Assessment Unit who require CTG monitoring and meet the inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Baskaran Thilaganathan | St-George's University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St George's University Hospital | London | SW17ORE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37055213 | Derived | Liu B, Marler E, Thilaganathan B, Bhide A. Ambulatory antenatal fetal electrocardiography in high-risk pregnancies (AMBER): protocol for a pilot prospective cohort study. BMJ Open. 2023 Apr 13;13(4):e062448. doi: 10.1136/bmjopen-2022-062448. | |
| 36944583 | Derived | Liu B, Thilaganathan B, Bhide A. Effectiveness of ambulatory non-invasive fetal electrocardiography: impact of maternal and fetal characteristics. Acta Obstet Gynecol Scand. 2023 May;102(5):577-584. doi: 10.1111/aogs.14543. Epub 2023 Mar 21. |
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