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

Completed · Not applicable

Conditions studied: Pregnancy Related

In brief

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.

Key facts

Study ID

NCT05498298

Run by

Bloom Technologies

People needed

53

Starts

2022-08-03

Expected to finish

2022-12-07

Last updated by the study team

2022-12-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Implanted pacemaker or any other implanted electrical device
• History of allergies to skin adhesives
• Irritated or lesioned skin at the electrodes locations

Where it is running

• Valley Perinatal Services — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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