Trials / Completed
CompletedNCT03969433
Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 231 (actual)
- Sponsor
- Bloom Technologies · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TMSi Porti | Data collections |
| DEVICE | Bloomlife sensor | Data collections |
Timeline
- Start date
- 2018-03-05
- Primary completion
- 2021-06-24
- Completion
- 2021-07-01
- First posted
- 2019-05-31
- Last updated
- 2022-01-25
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT03969433. Inclusion in this directory is not an endorsement.