Fetal MonitoringNCT03244865
Refinement of the OBMedical LaborView System
An observational study of Fetal Monitoring, run by OBMedical Company at 1 site in United States.
Trial summary
Despite its limitations, fetal heart rate (FHR) tracing analysis is the best monitor of fetal well-being during labor or preparation for cesarean delivery. Current monitoring methods: transabdominal ultrasound (CTG: cardiotocograph) and fetal scalp electrodes (FSE) have limitations (tracing loss during fetal movement… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Monitoring
- What is being tested?
- LaborView Electronic Fetal Monitor
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2016to 11 Apr 2018
- Phase
- Observational
- 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 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant Females admitted to Labor and Delivery at Shands UF Health who are over the age of 18 and able to consent themselves.
Who may be able to join
- Admitted to Labor and Delivery at Shands UF Health
- Are able to consent for themselves
Who cannot join
- Under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Shands Health
Gainesville, Florida, 32608
About this study
Official title: Refinement of LaborView Electronic Fetal Monitor
Despite its limitations, fetal heart rate (FHR) tracing analysis is the best monitor of fetal well-being during labor or preparation for cesarean delivery. Current monitoring methods: transabdominal ultrasound (CTG: cardiotocograph) and fetal scalp electrodes (FSE) have limitations (tracing loss during fetal movement, potential to confuse maternal for fetal heart rate, inability to monitor during cesarean section or abdominal surgery) and, in the latter case, risks (infection, hematoma). A reliable, non-invasive monitor of the fetal heart rate that can be used during labor, non-obstetric and obstetric surgery during pregnancy is needed. Recent developments in use of maternal abdominal electrodes for extraction of the FHR and contraction information inform this study.
LaborView®, developed by researchers at University of Florida (UF) College of Medicine and OBMedical, is an FDA-approved non-invasive labor monitoring device. Refinement of the extraction algorithms continues, and that work is most effectively performed at UF, where the primary researchers and OBMedical are located.
LaborView monitoring will be recorded from up to150 subjects admitted to Labor and Delivery at UFHealth. Data will be simultaneously obtained from the standard labor monitor. These signals will then be analyzed off-line for comparison and refinement of algorithms.
Read the detailed description
Despite its limitations, fetal heart rate (FHR) tracing analysis is the best monitor of fetal well being during labor. Typically, continuous electronic fetal monitoring is via transabdominal ultrasound (CTG: cardiotocograph). A transducer is strapped to the maternal abdomen and positioned in such a way to detect fetal rather than maternal heart rate. There are occasional periods of signal loss as the patient or her fetus moves, as well as times when the monitor incorrectly records the maternal signal. Maternal obesity presents particular challenges to non-invasive monitoring.
When there is particular concern regarding the fetal heart rate tracing the obstetrician may opt for a fetal scalp electrode (FSE). This is screwed into the fetus' presenting part through the opening in the cervix (requires ruptured membranes and adequate dilation). This signal is usually more reliable, but entails risks of chorioamnionitis, fetal scalp infection, scalp hematoma, and potential vertical transmission of maternal viruses including HIV and hepatitis.
Recently, devices have come to market that extract the FHR and uterine electromyograph (EMG) from maternal abdominal electrodes. The proposed study will provide data for refinement of the LaborView device produced by OBMedical.
Specific Aims:
The goal of this research is to evaluate the LaborView device under various settings and fetal heart rate accuracy as compared to a traditional CTG monitor.
Research Plan:
All patients admitted to the Labor \& Delivery Suite at UF Health, will be eligible for inclusion in the study except minors and those unable to consent for themselves.
Following written informed consent, the external monitors (tocodynamometer and ultrasound) may not be removed. Per LaborView directions, electrode application sites will be prepared to reduce skin impedance, electrodes will be applied to the maternal abdomen and data acquired for comparison with CTG data obtained through the traditional monitoring system. FHR, ECG (electrocardiography), and uterine activity data from the existing fetal monitors will be collected via a laptop PC connected to the systems for comparison. The comparison will be performed off-line.
Evaluation of the data obtained will include (1) comparison of the calculated FHR with that of the CTG and/or fetal scalp electrode.
Nothing is required of the subjects. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus. No longitudinal follow-up is planned or indicated.
- Conditions
- Fetal Monitoring
- Being tested
- LaborView Electronic Fetal Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaborView Electronic Fetal MonitorDevice
Per LaborView directions, electrode application sites will be prepared to reduce skin impedance, electrodes will be applied to the maternal abdomen and FHR data acquired for comparison with CTG data obtained through the traditional monitoring system. The comparison will be performed off-line.
Nothing is required of the subjects. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Females | All patients admitted to the Labor \& Delivery Suite at UF Health, will be eligible for inclusion in the study except minors and those unable to consent for themselves.
Nothing is required of the subjects. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus. No longitudinal follow-up is planned or indicated. Receives: Device: LaborView Electronic Fetal Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal Heart Rate With the Laborview System Versus the CTG Monitor - Pilot Comparison Study
Using standard of care CTG (Cardiotocography) already in place and the LaborView electrode-based FHR monitoring simultaneously, we will collect FHR data from both monitors simultaneously. We will compare the two FHR calculations using root mean squared error (RMSE).
Measured: 1 - 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start29 Sep 2016
- Primary completion11 Apr 2018
- Study completion11 Apr 2018
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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- OBMedical Company
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244865
- Sponsor's protocol ID
- PRO00009835
- Status last verified
- Jun 2019
- First submitted
- 3 Aug 2017
- Last updated
- 20 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refinement of LaborView Electronic Fetal Monitor
- ClinicalTrials.gov ID
- NCT03244865
- Acronym / sponsor ID
- PRO00009835
- Conditions
- Fetal Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- OBMedical CompanyUniversity, hospital or other
- Collaborators
- University of Florida
- Study start
- 29 Sep 2016 (actual)
- Primary completion
- 11 Apr 2018 (actual)
- Study completion
- 11 Apr 2018 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Posted 20 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite its limitations, fetal heart rate (FHR) tracing analysis is the best monitor of fetal well-being during labor or preparation for cesarean delivery. Current monitoring methods: transabdominal ultrasound (CTG: cardiotocograph) and fetal scalp electrodes (FSE) have limitations (tracing loss during fetal movement, potential to confuse maternal for fetal heart rate, inability to monitor during cesarean section or abdominal surgery) and, in the latter case, risks (infection, hematoma). A reliable, non-invasive monitor of the fetal heart rate that can be used during labor, non-obstetric and obstetric surgery during pregnancy is needed. Recent developments in use of maternal abdominal electrodes for extraction of the FHR and contraction information inform this study.
LaborView®, developed by researchers at University of Florida (UF) College of Medicine and OBMedical, is an FDA-approved non-invasive labor monitoring device. Refinement of the extraction algorithms continues, and that work is most effectively performed at UF, where the primary researchers and OBMedical are located.
LaborView monitoring will be recorded from up to150 subjects admitted to Labor and Delivery at UFHealth. Data will be simultaneously obtained from the standard labor monitor. These signals will then be analyzed off-line for comparison and refinement of algorithms.
Detailed description
Despite its limitations, fetal heart rate (FHR) tracing analysis is the best monitor of fetal well being during labor. Typically, continuous electronic fetal monitoring is via transabdominal ultrasound (CTG: cardiotocograph). A transducer is strapped to the maternal abdomen and positioned in such a way to detect fetal rather than maternal heart rate. There are occasional periods of signal loss as the patient or her fetus moves, as well as times when the monitor incorrectly records the maternal signal. Maternal obesity presents particular challenges to non-invasive monitoring.
When there is particular concern regarding the fetal heart rate tracing the obstetrician may opt for a fetal scalp electrode (FSE). This is screwed into the fetus' presenting part through the opening in the cervix (requires ruptured membranes and adequate dilation). This signal is usually more reliable, but entails risks of chorioamnionitis, fetal scalp infection, scalp hematoma, and potential vertical transmission of maternal viruses including HIV and hepatitis.
Recently, devices have come to market that extract the FHR and uterine electromyograph (EMG) from maternal abdominal electrodes. The proposed study will provide data for refinement of the LaborView device produced by OBMedical.
Specific Aims:
The goal of this research is to evaluate the LaborView device under various settings and fetal heart rate accuracy as compared to a traditional CTG monitor.
Research Plan:
All patients admitted to the Labor \& Delivery Suite at UF Health, will be eligible for inclusion in the study except minors and those unable to consent for themselves.
Following written informed consent, the external monitors (tocodynamometer and ultrasound) may not be removed. Per LaborView directions, electrode application sites will be prepared to reduce skin impedance, electrodes will be applied to the maternal abdomen and data acquired for comparison with CTG data obtained through the traditional monitoring system. FHR, ECG (electrocardiography), and uterine activity data from the existing fetal monitors will be collected via a laptop PC connected to the systems for comparison. The comparison will be performed off-line.
Evaluation of the data obtained will include (1) comparison of the calculated FHR with that of the CTG and/or fetal scalp electrode.
Nothing is required of the subjects. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus. No longitudinal follow-up is planned or indicated.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Females | – | Device: LaborView Electronic Fetal MonitorAll patients admitted to the Labor \& Delivery Suite at UF Health, will be eligible for inclusion in the study except minors and those unable to consent for themselves. Nothing is required of the subjects. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus. No longitudinal follow-up is planned or indicated. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant Females admitted to Labor and Delivery at Shands UF Health who are over the age of 18 and able to consent themselves.
Key inclusion criteria (2 listed)
- Admitted to Labor and Delivery at Shands UF Health
- Are able to consent for themselves
Key exclusion criteria (1 listed)
- Under the age of 18
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 |
|---|---|---|
| LaborView Electronic Fetal MonitorPer LaborView directions, electrode application sites will be prepared to reduce skin impedance, electrodes will be applied to the maternal abdomen and FHR data acquired for comparison with CTG data obtained through the traditional monitoring system. The comparison will be performed off-line. Nothing is required of the subjects. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus. | Device | Pregnant Females |
Primary outcome
Fetal Heart Rate With the Laborview System Versus the CTG Monitor - Pilot Comparison Study
Time frame: 1 - 8 hours
Using standard of care CTG (Cardiotocography) already in place and the LaborView electrode-based FHR monitoring simultaneously, we will collect FHR data from both monitors simultaneously. We will compare the two FHR calculations using root mean squared error (RMSE).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Monitoring, run by OBMedical Company at 1 site 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 2 inclusion and 1 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 20 Sep 2019. 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 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 20 Sep 2019). 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?
Fetal Heart Rate With the Laborview System Versus the CTG Monitor - Pilot Comparison Study (time frame: 1 - 8 hours). 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 20 Sep 2019.