Fetal MonitoringNCT05665400
A Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring
A study testing Bloomlife Lovelace FT in people with Fetal Monitoring, run by Bloom Technologies at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Monitoring
- What is being tested?
- Bloomlife Lovelace FT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Jul 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fetal Monitoring
- Being tested
- Bloomlife Lovelace FT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bloomlife Lovelace FTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Bloomlife Lovelace FT | Experimental | Not described Receives: Device: Bloomlife Lovelace FT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of agreement between Bloomlife Lovelace FT and CTG in fetal heart rate
Bland-Altman analysis, based on a 95% limits of agreement.
Measured: 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.
Measured: 1 hour
Performance metrics of Contraction Detection with Bloomlife Lovelace FT
Sensitivity, False Event Rate, Positive Percentage Agreement, Negative Percentage Agreement.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start13 Jul 2022
- Primary completion29 Jun 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bloom Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caroline Van Holsbeke, MD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665400
- Sponsor's protocol ID
- LOV-01-2022-EU
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional, Interventional, Exploratory Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring
- ClinicalTrials.gov ID
- NCT05665400
- Acronym / sponsor ID
- LOV-01-2022-EU
- Conditions
- Fetal Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Bloom TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bloomlife Lovelace FT | Experimental | Device: Bloomlife Lovelace FT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bloomlife Lovelace FTBloomlife 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. | Device | Bloomlife Lovelace FT |
Primary outcome
Extent of agreement between Bloomlife Lovelace FT and CTG in fetal heart rate
Time frame: 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
Time frame: 1 hour
Bland-Altman analysis, based on a 95% limits of agreement.
Performance metrics of Contraction Detection with Bloomlife Lovelace FT
Time frame: 1 hour
Sensitivity, False Event Rate, Positive Percentage Agreement, Negative Percentage Agreement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Fetal Monitoring
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Wearable Ultrasound Patch in Parturients
Pregnancy - Labor Monitoring, Labor and Childbirth
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Safety and Feasibility of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening
Induced Labor, Cervical Ripening
Not yet recruitingObservational study
Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography
Fetal Hypoxia, Fetal Distress
Recruiting
Study of Fetal Health Outcomes: Working With a Missouri E-telehealth Platform (The SHOW-ME Study)
Pregnancy
Recruiting
Implementation Models for Blood Pressure Monitoring in Pregnancy and Postpartum: Connected MOM Plus
Maternal Health Care, Hypertensive Disorder of Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Van Holsbeke, MD principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bloomlife Lovelace FT in people with Fetal Monitoring, run by Bloom Technologies at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of agreement between Bloomlife Lovelace FT and CTG in fetal heart rate (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.