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

NCT05665400 | Completed

• 1 other identifier: LOV-01-2022-EU
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Bloomlife Lovelace FT

EXPERIMENTAL

Device: Bloomlife Lovelace FT

Interventions

Bloomlife Lovelace FT 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.

Bloomlife Lovelace FT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bloom Technologies: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Study Officials

• Caroline Van Holsbeke, MD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: December 27, 2022
• Study Start: July 13, 2022
• Primary Completion: June 29, 2023
• Study Completion: November 30, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

BE (1)