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

Not Applicable

Completed

• Conditions: Fetal Monitoring
• Interventions: Device: Bloomlife Lovelace FT

• Registration Number: NCT05665400
• Lead Sponsor: Bloom Technologies

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-21
• Study Start: 2022-07-13
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-27
• Primary Completion: 2023-06-29
• Study Completion: 2023-11-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

• Pregnant woman ≥ 18 years old
• Gestational age greater or equal to 24 weeks and 0 days
• Singleton pregnancy
• Ability to read and understand Dutch
• 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 Bloomlife Lovelace FT electrodes locations
• Contraindication to the use of CTG based on physician's decision (e.g. due to preterm contractions)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bloomlife Lovelace FT	Bloomlife Lovelace FT	-

Primary Outcome Measures

Name	Time	Method
Extent of agreement between Bloomlife Lovelace FT and CTG in fetal heart rate	1 hour	Bland-Altman analysis, based on a 95% limits of agreement.
Extent of agreement between Bloomlife Lovelace FT and CTG in maternal heart rate	1 hour	Bland-Altman analysis, based on a 95% limits of agreement.
Performance metrics of Contraction Detection with Bloomlife Lovelace FT	1 hour	Sensitivity, False Event Rate, Positive Percentage Agreement, Negative Percentage Agreement.

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium