A Clinical Study to Investigate the Reliability of Fetal Heart Rate and Maternal Heart Rate Signals Extracted From Biopotential Data
NCT ID: NCT05498298
Last Updated: 2022-12-14
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
53 participants
INTERVENTIONAL
2022-08-03
2022-12-07
Brief Summary
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In this study, Bloom Technologies wants to investigate the reliability of this new technology.
For this reason, a device that records very high-quality data (g,Hlamp) was chosen. The study device is attached to the body by means of electrodes (up to 32) that can be safely attached to the skin. Most of the electrodes are placed on the abdomen, and a few on the chest and back.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Gtec
Biopotentials measurement with gtec device
A measurement of 40 minutes is performed with the gtec g.Hlamp to collect biopotential signals. 32 electrodes are attached to the body (abdomen, thorax and back).
Interventions
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Biopotentials measurement with gtec device
A measurement of 40 minutes is performed with the gtec g.Hlamp to collect biopotential signals. 32 electrodes are attached to the body (abdomen, thorax and back).
Eligibility Criteria
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Inclusion Criteria
* Gestational age ≥ 30 weeks and 0 days
* Singleton pregnancy
* Ability to read and understand English or Spanish
* Willingness to participate in the study
Exclusion Criteria
* History of allergies to skin adhesives
* Irritated or lesioned skin at the electrodes locations
18 Years
FEMALE
Yes
Sponsors
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Bloom Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Ravindu Gunatilake
Role: PRINCIPAL_INVESTIGATOR
Valley Perinatal Services
Locations
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Valley Perinatal Services
Phoenix, Arizona, United States
Countries
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Other Identifiers
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LOV-02-2022-US
Identifier Type: -
Identifier Source: org_study_id