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The purpose of this study is to support the development of a new generation of the Bloomlife sensor, enabling continuous monitoring of foetal wellbeing.
Data is collected in four Phases, with different experimental setups. Recordings with investigational and reference devices are performed on the subjects, at different gestational ages.
The collected data is used for developing algorithms for the extraction of parameters descriptive of foetal wellbeing.
Clinical information related to subjects' pregnancy and foetal health is also collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I | Experimental | Data collections are performed with TMSi Porti system and CTG (reference) |
|
| Phases II-III-IV | Experimental | Data collections are performed with the Bloomlife sensor and CTG (reference) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMSi Porti | Device | Data collections |
| |
| Bloomlife sensor |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy and reliability in the detection of foetal heart rate | Foetal heart rate is extracted from the collected electrophysiological data and compared to the reference | Throughout the subject's participation in the study, from inclusion until delivery |
| Accuracy and reliability in the detection of foetal movements | Foetal movements are detected from the collected sensor data and compared to the reference | Throughout the subject's participation in the study, from inclusion until delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried Gyselaers, MD, PhD | Ziekenhuis Oost-Limburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | Limburg | 3600 | Belgium |
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| Device |
Data collections |
|