NCT05665400

A Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring

A Cross-sectional, Interventional, Exploratory Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Bloom Technologies · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Bloomlife Lovelace FT is a non-invasive, wireless, external measurement system used to measure accelerometer and electrophysiological signals on pregnant women with a singleton pregnancy, by acquiring biopotential signals from abdominal surface electrodes. In this study, Bloomlife Lovelace FT is used to collect the dataset needed for the development of a future product (Bloomlife Lovelace) for the monitoring of fetal heart rate, maternal heart rate and uterine activity.

Conditions

• Fetal Monitoring

Interventions

Type	Name	Description
DEVICE	Bloomlife Lovelace FT	Bloomlife Lovelace FT is a non-invasive, wireless, external measurement system used to measure accelerometer and electrophysiological signals on pregnant women with a singleton pregnancy, by acquiring biopotential signals from abdominal surface electrodes.

Timeline

• Start date: 2022-07-13
• Primary completion: 2023-06-29
• Completion: 2023-11-30
• First posted: 2022-12-27
• Last updated: 2024-07-03

Locations

1 site across 1 country: Belgium