Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring
NCT ID: NCT03969433
Last Updated: 2022-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
231 participants
INTERVENTIONAL
2018-03-05
2021-07-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Phase I
Data collections are performed with TMSi Porti system and CTG (reference)
TMSi Porti
Data collections
Phases II-III-IV
Data collections are performed with the Bloomlife sensor and CTG (reference)
Bloomlife sensor
Data collections
Interventions
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TMSi Porti
Data collections
Bloomlife sensor
Data collections
Eligibility Criteria
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Inclusion Criteria
* Gestational age of at least 20 weeks
* Singleton pregnancy
* Willingness to participate in the study
Exclusion Criteria
* Implanted pacemaker or any other implanted electrical device
* History of allergies to silicone-based adhesives
18 Years
FEMALE
Yes
Sponsors
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Bloom Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Wilfried Gyselaers, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ziekenhuis Oost-Limburg
Locations
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Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
Countries
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Other Identifiers
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BEATLE
Identifier Type: -
Identifier Source: org_study_id
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