Pregnancy Related
Conditions
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.
Interventions
DEVICEBiopotentials 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).
Sponsors
Bloom Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed