NCT05498298

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Bloom Technologies · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy Related

Interventions

Type	Name	Description
DEVICE	Biopotentials measurement with gtec 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).

Timeline

• Start date: 2022-08-03
• Primary completion: 2022-12-07
• Completion: 2022-12-07
• First posted: 2022-08-12
• Last updated: 2022-12-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study