Foetal WellbeingNCT03969433
Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring
A study testing TMSi Porti and Bloomlife sensor in people with Foetal Wellbeing, run by Bloom Technologies at 1 site in Belgium.
Trial summary
The purpose of this study is to support the development of a new generation of the Bloomlife sensor, enabling continuous monitoring of foetal wellbeing. Data is collected in four Phases, with different experimental setups. 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
- Foetal Wellbeing
- What is being tested?
- TMSi Porti and Bloomlife sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Mar 2018to 1 Jul 2021
- 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
- Gestational age of at least 20 weeks
- Singleton pregnancy
- Willingness to participate in the study
Who cannot join
- Multiple pregnancy
- Implanted pacemaker or any other implanted electrical device
- History of allergies to silicone-based adhesives
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to support the development of a new generation of the Bloomlife sensor, enabling continuous monitoring of foetal wellbeing.
Data is collected in four Phases, with different experimental setups. Recordings with investigational and reference devices are performed on the subjects, at different gestational ages.
The collected data is used for developing algorithms for the extraction of parameters descriptive of foetal wellbeing.
Clinical information related to subjects' pregnancy and foetal health is also collected.
- Conditions
- Foetal Wellbeing
- Being tested
- TMSi Porti, Bloomlife sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSi PortiDevice
Data collections
Bloomlife sensorDevice
Data collections
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Experimental | Data collections are performed with TMSi Porti system and CTG (reference) Receives: Device: TMSi Porti |
| Phases II-III-IV | Experimental | Data collections are performed with the Bloomlife sensor and CTG (reference) Receives: Device: Bloomlife sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy and reliability in the detection of foetal heart rate
Foetal heart rate is extracted from the collected electrophysiological data and compared to the reference
Measured: Throughout the subject's participation in the study, from inclusion until delivery
Accuracy and reliability in the detection of foetal movements
Foetal movements are detected from the collected sensor data and compared to the reference
Measured: Throughout the subject's participation in the study, from inclusion until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start5 Mar 2018
- Primary completion24 Jun 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foetal WellbeingStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bloom Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilfried Gyselaers, MD, PhD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969433
- Sponsor's protocol ID
- BEATLE
- Status last verified
- Jan 2022
- First submitted
- 28 May 2019
- Last updated
- 25 Jan 2022
- 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 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring
- ClinicalTrials.gov ID
- NCT03969433
- Acronym / sponsor ID
- BEATLE
- Conditions
- Foetal Wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Bloom TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 31 May 2019 (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.
The purpose of this study is to support the development of a new generation of the Bloomlife sensor, enabling continuous monitoring of foetal wellbeing.
Data is collected in four Phases, with different experimental setups. Recordings with investigational and reference devices are performed on the subjects, at different gestational ages.
The collected data is used for developing algorithms for the extraction of parameters descriptive of foetal wellbeing.
Clinical information related to subjects' pregnancy and foetal health is also collected.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I | Experimental | Device: TMSi PortiData collections are performed with TMSi Porti system and CTG (reference) |
| Phases II-III-IV | Experimental | Device: Bloomlife sensorData collections are performed with the Bloomlife sensor and CTG (reference) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant
- Gestational age of at least 20 weeks
- Singleton pregnancy
- Willingness to participate in the study
Key exclusion criteria (3 listed)
- Multiple pregnancy
- Implanted pacemaker or any other implanted electrical device
- History of allergies to silicone-based adhesives
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 |
|---|---|---|
| TMSi PortiData collections | Device | Phase I |
| Bloomlife sensorData collections | Device | Phases II-III-IV |
Primary outcome
Accuracy and reliability in the detection of foetal heart rate
Time frame: Throughout the subject's participation in the study, from inclusion until delivery
Foetal heart rate is extracted from the collected electrophysiological data and compared to the reference
Accuracy and reliability in the detection of foetal movements
Time frame: Throughout the subject's participation in the study, from inclusion until delivery
Foetal movements are detected from the collected sensor data and compared to the reference
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 25 Jan 2022.
- Individual participant dataSharing planned: Undecided
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.
Wilfried Gyselaers, MD, PhD 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 TMSi Porti and Bloomlife sensor in people with Foetal Wellbeing, 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 4 inclusion and 3 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 25 Jan 2022. 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?
Accuracy and reliability in the detection of foetal heart rate (time frame: Throughout the subject's participation in the study, from inclusion until delivery). The study lists 2 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 25 Jan 2022.