Foetal Wellbeing
Conditions
Brief summary
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.
Interventions
DEVICETMSi Porti
Data collections
DEVICEBloomlife sensor
Data collections
Sponsors
Bloom Technologies
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant * Gestational age of at least 20 weeks * Singleton pregnancy * Willingness to participate in the study
Exclusion criteria
* Multiple pregnancy * Implanted pacemaker or any other implanted electrical device * History of allergies to silicone-based adhesives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy and reliability in the detection of foetal heart rate | Throughout the subject's participation in the study, from inclusion until delivery | Foetal heart rate is extracted from the collected electrophysiological data and compared to the reference |
| Accuracy and reliability in the detection of foetal movements | Throughout the subject's participation in the study, from inclusion until delivery | Foetal movements are detected from the collected sensor data and compared to the reference |
Countries
Belgium
Outcome results
None listed