A Clinical Study to Investigate the Reliability of Fetal Heart Rate and Maternal Heart Rate Signals Extracted From Biopotential Data

Bloom Technologies

Status: Completed

Conditions: Pregnancy Related

Treatments: Device: Biopotentials measurement with gtec device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05498298

LOV-02-2022-US

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Gtec

Experimental group

Treatment:

Device: Biopotentials measurement with gtec device