A Clinical Study to Investigate the Reliability of Fetal Heart Rate and Maternal Heart Rate Signals Extracted From Biopotential Data
Not Applicable
Completed
- Conditions
- Pregnancy Related
- Interventions
- Device: Biopotentials measurement with gtec device
- Registration Number
- NCT05498298
- Lead Sponsor
- Bloom Technologies
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 53
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gtec Biopotentials measurement with gtec device -
- Primary Outcome Measures
Name Time Method Reliability in fetal heart rate extraction 40 minutes Percentage of a recording with a fetal heart rate signal extracted
Reliability in maternal heart rate extraction 40 minutes Percentage of a recording with a maternal heart rate signal extracted
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Valley Perinatal Services
🇺🇸Phoenix, Arizona, United States