Fetal MonitoringNSTNCT04915131
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring
A study testing Bloomlife MFM-Pro in people with Fetal Monitoring, run by Bloom Technologies at 2 sites in United States.
Trial summary
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate and maternal heart rate on pregnant women with a singleton pregnancy, starting from 32 weeks of gestation. 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
- 121 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Apr 2021to 5 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 English or Spanish
- 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
- Irritated or lesioned skin at the Bloomlife MFM-Pro electrodes locations
- Contraindication to the use of CTG
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ochsner
New Orleans, Louisiana, 70115
Valley Perinatal Services
Phoenix, Arizona, 85004
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 Fetal Heart Rate and Maternal Heart Rate When Performing Antepartum Fetal Monitoring
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate and maternal heart rate on pregnant women with a singleton pregnancy, starting from 32 weeks of gestation.
The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring.
Read the detailed description
The study consisted of 2 phases: a pilot phase and a pivotal phase. The pilot phase of the study was aimed at testing the Bloomlife MFM-Pro device prior to validation in the pivotal phase of the study. The pivotal phase of the study was aimed at validating that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring.
- 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 and maternal heart rate on pregnant women with a singleton pregnancy.
The system acquires biopotential signals from abdominal surface electrodes.
| Study group | Role | What they receive |
|---|---|---|
| Bloomlife MFM-Pro | Other | 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
Measured: 5 minutes
Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start6 Apr 2021
- Primary completion28 Apr 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bloom Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Avinash Patil, Principal investigator, Valley Perinatal Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915131
- Sponsor's protocol ID
- NST-01-2021-US
- Acronym
- NST
- Status last verified
- Sep 2023
- First submitted
- 10 Apr 2021
- Last updated
- 18 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. 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 Fetal Heart Rate and Maternal Heart Rate When Performing Antepartum Fetal Monitoring
- ClinicalTrials.gov ID
- NCT04915131
- Acronym / sponsor ID
- NST / NST-01-2021-US
- Conditions
- Fetal Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Bloom TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Posted 18 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate and maternal heart rate on pregnant women with a singleton pregnancy, starting from 32 weeks of gestation.
The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring.
Detailed description
The study consisted of 2 phases: a pilot phase and a pivotal phase. The pilot phase of the study was aimed at testing the Bloomlife MFM-Pro device prior to validation in the pivotal phase of the study. The pivotal phase of the study was aimed at validating that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring.
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 | Other | 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 English or Spanish
- Willingness to participate in the study
Key exclusion criteria (5 listed)
- Implanted pacemaker or any other implanted electrical device
- Plurality higher than 1
- History of allergies to skin adhesives
- Irritated or lesioned skin at the Bloomlife MFM-Pro electrodes locations
- Contraindication to the use of 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 and maternal heart rate on pregnant women with a singleton pregnancy. The system acquires biopotential signals from abdominal surface electrodes. | Device | Bloomlife MFM-Pro |
Primary outcome
Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate
Time frame: 5 minutes
Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate
Time frame: 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Avinash Patil principal investigator
Valley Perinatal Services
2 sites 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 2 sites in United States.
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 5 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 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 18 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 5 minutes). 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 18 Oct 2023.