Trial Outcomes & Findings for Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device (NCT NCT02993354)
NCT ID: NCT02993354
Last Updated: 2024-03-08
Results Overview
Continuity in readings of contractions, as measured in the number of minutes without a readable tracing in a sample tracing, between the novel EUM device and the external tocodynamometer (standard care) were assessed in pregnant preterm patients. An uninterpretable tracing was defined as any contraction, or any period of contractions, with unclear/uninterpretable baseline, peak onset/timing, height/peak, or duration of contraction.
COMPLETED
48 participants
within 4 hours of device application
2024-03-08
Participant Flow
Prospective observational study of 48 patients at Montefiore Medical Center. Recruitment commenced following IRB approval in FEB 2017 (first patient was enrolled July 1, 2017). Study recruitment was paused due to COVID from March 2020 to June 2020 and resumed from June 2020 to May 2021.
All 48 participants who enrolled were simultaneously monitored with the EUM Device and the typical tocodynamometer.
Participant milestones
| Measure |
Pregnant Women
Pregnant women with singleton pregnancy with gestational age greater than or equal to 24 weeks were monitored simultaneously with two different devices to measure contractions: the EUM300 (electrical uterine myography) and tocodynamometry
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device
Baseline characteristics by cohort
| Measure |
Pregnant Women
n=48 Participants
Pregnant women with singleton pregnancy with gestational age greater than or equal to 24 weeks.
The EUM300 (electrical uterine myography): External monitor intended for the evaluation of electrical signals originating in the uterus, thus providing a tool for measuring uterine activity as well as fetal heart rate.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
28.17 years
STANDARD_DEVIATION 5.37 • n=99 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: within 4 hours of device applicationContinuity in readings of contractions, as measured in the number of minutes without a readable tracing in a sample tracing, between the novel EUM device and the external tocodynamometer (standard care) were assessed in pregnant preterm patients. An uninterpretable tracing was defined as any contraction, or any period of contractions, with unclear/uninterpretable baseline, peak onset/timing, height/peak, or duration of contraction.
Outcome measures
| Measure |
EUM Device
n=48 Participants
Contractions monitored using the EUM device
|
Tocodynamometer
n=48 Participants
Contractions monitored with tocodynamometer
|
|---|---|---|
|
Continuity in Readings of Contractions
|
0 Number of minutes
Standard Deviation 0
|
0 Number of minutes
Standard Deviation 0
|
PRIMARY outcome
Timeframe: within 4 hours of device applicationPopulation: Fetal Heart Rate data was not collected and therefore not analyzed
Continuity in Fetal Heart rate readings, as measured by the number of minutes without a readable tracing in a sample tracing between the novel EUM/EMG device and the external tocodynamometer (standard care) will be assessed in pregnant preterm patients. An uninterpretable tracing is defined as any period of fetal heart rate tracing with unclear/uninterpretable baseline, variability, onset/timing, peak, frequency, or duration of accelerations/decelerations
Outcome measures
Outcome data not reported
Adverse Events
Pregnant Women
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place