NCT05498298
Completed
Not Applicable
A Cross-sectional, Interventional, Exploratory Clinical Study to Investigate the Reliability of Fetal Heart Rate and Maternal Heart Rate Signals Extracted From Biopotential Data
Bloom Technologies1 site in 1 country53 target enrollmentAugust 3, 2022
ConditionsPregnancy Related
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy Related
- Sponsor
- Bloom Technologies
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Reliability in fetal heart rate extraction
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Bloom Technologies is developing a wearable device for monitoring pregnancy.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregnant woman ≥ 18 years old
- •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
- •Implanted pacemaker or any other implanted electrical device
- •History of allergies to skin adhesives
- •Irritated or lesioned skin at the electrodes locations
Outcomes
Primary Outcomes
Reliability in fetal heart rate extraction
Time Frame: 40 minutes
Percentage of a recording with a fetal heart rate signal extracted
Reliability in maternal heart rate extraction
Time Frame: 40 minutes
Percentage of a recording with a maternal heart rate signal extracted
Study Sites (1)
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