Fetal MonitoringNSTNCT05060172
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring
A study testing Bloomlife MFM-Pro in people with Fetal Monitoring, run by Bloom Technologies at 1 site in Belgium.
Trial summary
Bloomlife has developed a wearable system (Bloomlife MFM-Pro) that can allow fetal monitoring to be conveniently performed in healthcare settings under supervision of a healthcare professional. 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 MFM-Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Jun 2021to 25 Nov 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 woman ≥ 18 years old
- Gestational age ≥ 32 weeks and 0 days
- Singleton pregnancy
- Ability to read and understand Dutch or English
- Willingness to participate in the study
Who cannot join
- Implanted pacemaker or any other implanted electrical device
- Plurality higher than 1
- History of allergies to skin adhesives
- Contraindication to the use of the CTG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-sectional, Interventional, Single-arm Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring
Bloomlife has developed a wearable system (Bloomlife MFM-Pro) that can allow fetal monitoring to be conveniently performed in healthcare settings under supervision of a healthcare professional.
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy.
The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for routine non-stress test (NST) performed at the hospital.
- Conditions
- Fetal Monitoring
- Being tested
- Bloomlife MFM-Pro
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bloomlife MFM-ProDevice
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy.
The system acquires biopotential signals from abdominal surface electrodes and measures the fetal electrocardiography, maternal electrocardiography, electrohysterography, as well as accelerometer data.
| Study group | Role | What they receive |
|---|---|---|
| Bloomlife MFM-Pro | Experimental | Not described Receives: Device: Bloomlife MFM-Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of agreement between Bloomlife MFM-Pro and CTG in fetal heart rate
Bland-Altman analysis, based on a 95% limits of agreement
Measured: 1 hour
Extent of agreement between Bloomlife MFM-Pro and CTG in maternal heart rate
Bland-Altman analysis, based on a 95% limits of 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 posted29 Sep 2021
- Study start25 Jun 2021
- Primary completion9 Nov 2021
- Study completion25 Nov 2021
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bloom Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilfried Gyselaers, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060172
- Sponsor's protocol ID
- NST-01-2020-EU
- Acronym
- NST
- Status last verified
- Jan 2022
- First submitted
- 31 May 2021
- 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
- A Cross-sectional, Interventional, Single-arm Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring
- ClinicalTrials.gov ID
- NCT05060172
- Acronym / sponsor ID
- NST / NST-01-2020-EU
- Conditions
- Fetal Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Bloom TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 29 Sep 2021 (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 has developed a wearable system (Bloomlife MFM-Pro) that can allow fetal monitoring to be conveniently performed in healthcare settings under supervision of a healthcare professional.
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy.
The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for routine non-stress test (NST) performed at the hospital.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bloomlife MFM-Pro | Experimental | Device: Bloomlife MFM-Pro |
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 ≥ 32 weeks and 0 days
- Singleton pregnancy
- Ability to read and understand Dutch or English
- Willingness to participate in the study
Key exclusion criteria (4 listed)
- Implanted pacemaker or any other implanted electrical device
- Plurality higher than 1
- History of allergies to skin adhesives
- Contraindication to the use of the CTG
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 MFM-ProBloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy. The system acquires biopotential signals from abdominal surface electrodes and measures the fetal electrocardiography, maternal electrocardiography, electrohysterography, as well as accelerometer data. | Device | Bloomlife MFM-Pro |
Primary outcome
Extent of agreement between Bloomlife MFM-Pro 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 MFM-Pro and CTG in maternal heart rate
Time frame: 1 hour
Bland-Altman analysis, based on a 95% limits of 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 25 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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 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 MFM-Pro 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 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?
Extent of agreement between Bloomlife MFM-Pro and CTG in fetal heart rate (time frame: 1 hour). 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.