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

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.

Study Overview

• Status: Recruiting
• Conditions: Fetal Monitoring
• Intervention / Treatment: Device: Bloomlife Lovelace FT

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisa Rossetti; Phone Number: +32483653848; Email: elisa@bloom-life.com
• Study Contact Backup: Name: Julien Penders; Phone Number: 4156038067; Email: julien@bloom-life.com

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Recruiting
      • Ziekenhuis Oost-Limburg
      • Contact: Daimy Roebroek; Email: daimy.roebroek@zol.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bloomlife Lovelace FT	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bloom Technologies
• Investigators: Principal Investigator: Caroline Van Holsbeke, MD, Ziekenhuis Oost-Limburg

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: LOV-01-2022-EU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No