CompletedNot Applicable

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

United States53 participantsStarted 2022-08-03

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Reliability in fetal heart rate extraction

Timeframe: 40 minutes

Reliability in maternal heart rate extraction

Timeframe: 40 minutes

Trial details

NCT IDNCT05498298

SponsorBloom Technologies

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-07

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