Trial Outcomes & Findings for Refinement of the OBMedical LaborView System (NCT NCT03244865)
NCT ID: NCT03244865
Last Updated: 2019-09-20
Results Overview
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).
Recruitment status
COMPLETED
Target enrollment
35 participants
Primary outcome timeframe
1 - 8 hours
Results posted on
2019-09-20
Participant Flow
Participant milestones
| Measure |
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 participants. 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.
LaborView Electronic Fetal Monitor: 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, 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.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Refinement of the OBMedical LaborView System
Baseline characteristics by cohort
| Measure |
Pregnant Females
n=35 Participants
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.
LaborView Electronic Fetal Monitor: 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, 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 30.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
|
Number of Subjects in active labor
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 - 8 hoursUsing 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).
Outcome measures
| Measure |
Pregnant Females
n=35 Participants
There is only one arm in this study. All monitored patients admitted to Labor \& Delivery at UF Health, are eligible for inclusion in the study except minors and those unable to consent for themselves. They are non-invasively monitored for 1 to several hours. The information obtained is not 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.
All subjects in the study maintain the standard CTG monitoring they are using prior to enrollment in the study. The LaborView Electronic Fetal Monitor is added to the subject and both standard CTG FHR and LaborView FHR are collected simultaneously. LaborView electrode application sites are prepared to reduce skin impedance, and electrodes are applied to the maternal abdomen. The data collection laptop collects data from the standard monitor via serial port of the CTG and from LaborView via USB. The comparison of data is performed off-line.
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|---|---|
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Fetal Heart Rate With the Laborview System Versus the CTG Monitor - Pilot Comparison Study
|
5.282 beats per minute
Interval 4.8 to 5.75
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Adverse Events
Pregnant Females
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Tammy Euliano
UF Health Department of Anesthesiology
Phone: 352-514-7460
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place