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

NCT ID: NCT05665400

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-13
• Study Completion Date: 2023-11-30

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.

Conditions

Fetal Monitoring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Bloomlife Lovelace FT

Group Type: EXPERIMENTAL

Bloomlife Lovelace FT

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bloom Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Van Holsbeke, MD

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Locations

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Countries

Belgium

Other Identifiers

LOV-01-2022-EU

Identifier Type: -

Identifier Source: org_study_id