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

Bloom Technologies53 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Pregnancy Related

Interventions

Biopotentials measurement with gtec deviceDEVICE

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

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Valley Perinatal Services

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Reliability in fetal heart rate extraction

Percentage of a recording with a fetal heart rate signal extracted

Time frame: 40 minutes

Reliability in maternal heart rate extraction

Percentage of a recording with a maternal heart rate signal extracted

Time frame: 40 minutes

Data from ClinicalTrials.gov

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