Brief Summary
The EUM (electrical uterine myography) (OB Tools, Israel) was tested and found to be reliable as a non-invasive method for evaluating uterine contractions and the fetal heart rate. It is safe and effective in monitoring uterine contractions. The investigators propose to perform a study to validate the accuracy and clinical usefulness of the EUM device by simultaneously monitoring obese patients with current method of external tocodynamometry with the EUM device. Providers will be blinded to the results of the EUM device. Caregivers will continue care as per current guidelines using the information obtained from the current monitoring methods. Information obtained from the EUM devices will not be used to determine the clinical course of action.
Brief Title
Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device
Detailed Description
Purpose:
The investigators propose to perform a study to validate the accuracy and clinical usefulness of the EUM device by comparing it with simultaneous use of current methods (external tocodynamometry) among obese patients.
Objective:
Compare the interpretability of the contractions recorded using the EUM device vs. those obtained from external tocodynamometer among obese pregnant women.
The investigators propose to perform a study to validate the accuracy and clinical usefulness of the EUM device by comparing it with simultaneous use of current methods (external tocodynamometry) among obese patients.
Objective:
Compare the interpretability of the contractions recorded using the EUM device vs. those obtained from external tocodynamometer among obese pregnant women.
Completion Date
Completion Date Type
Actual
Conditions
Contraction
Eligibility Criteria
Inclusion Criteria:
1. Maternal age \>18 years old
2. Singleton pregnancy
3. Gestational age of 24 completed weeks or greater based on the estimated due date as calculated from last menstrual period or early ultrasound
4. Category I (reassuring) fetal heart rate tracing at time of enrollment
Exclusion Criteria:
1. Fetal anomaly or chromosome defect
2. Allergy to silver
3. Woman with implanted electronic device of any kind
4. Irritated skin or open wound on the abdominal wall
1. Maternal age \>18 years old
2. Singleton pregnancy
3. Gestational age of 24 completed weeks or greater based on the estimated due date as calculated from last menstrual period or early ultrasound
4. Category I (reassuring) fetal heart rate tracing at time of enrollment
Exclusion Criteria:
1. Fetal anomaly or chromosome defect
2. Allergy to silver
3. Woman with implanted electronic device of any kind
4. Irritated skin or open wound on the abdominal wall
Inclusion Criteria
Inclusion Criteria:
1. Maternal age \>18 years old
2. Singleton pregnancy
3. Gestational age of 24 completed weeks or greater based on the estimated due date as calculated from last menstrual period or early ultrasound
4. Category I (reassuring) fetal heart rate tracing at time of enrollment
1. Maternal age \>18 years old
2. Singleton pregnancy
3. Gestational age of 24 completed weeks or greater based on the estimated due date as calculated from last menstrual period or early ultrasound
4. Category I (reassuring) fetal heart rate tracing at time of enrollment
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02993354
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2015-4881
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device
Primary Outcomes
Outcome Description
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.
Outcome Measure
Continuity in Readings of Contractions
Outcome Time Frame
within 4 hours of device application
Outcome Description
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 Measure
Continuity in Readings of Fetal Heart Rate
Outcome Time Frame
within 4 hours of device application
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Pregnant women
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jessica Atrio
Investigator Email
jatrio@montefiore.org