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

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.

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Key information

Conditions

Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Valley Perinatal Services

Phoenix, Arizona, 85004, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopotentials measurement with gtec device

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).

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

Sponsors and collaborators

Lead sponsor

Bloom Technologies

Industry

Registry information

Official study title

A Cross-sectional, Interventional, Exploratory Clinical Study to Investigate the Reliability of Fetal Heart Rate and Maternal Heart Rate Signals Extracted From Biopotential Data

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Aug 12, 2022
Registry last updated: Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed