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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women | Pregnant women with singleton pregnancy with gestational age greater than or equal to 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The EUM300 (electrical uterine myography) | Device | This study involves monitoring one group of pregnant women for contractions simultaneously using two different devices to determine if one is superior: the usual tocodynamometer commonly used. Women are simultaneously monitored with both devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Continuity in Readings of Contractions | 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. | within 4 hours of device application |
| Continuity in Readings of Fetal Heart Rate | 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 | within 4 hours of device application |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Peter Bernstein, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jack D. Weiler Hospital of Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33852969 | Derived | Moni SS, Kirshenbaum R, Comfort L, Kuba K, Wolfe D, Xie X, Negassa A, Bernstein PS. Noninvasive monitoring of uterine electrical activity among patients with obesity: a new external monitoring device. Am J Obstet Gynecol MFM. 2021 Jul;3(4):100375. doi: 10.1016/j.ajogmf.2021.100375. Epub 2021 Apr 20. |
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All 48 participants who enrolled were simultaneously monitored with the EUM Device and the typical tocodynamometer.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnant Women | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Continuity in Readings of Contractions | 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. | Posted | Mean | Standard Deviation | Number of minutes | within 4 hours of device application |
|
Duration of labor evaluation, up to 15 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregnant Women | pregnant women with gestational age 24-36 weeks and 6 days presenting with preterm contractions or induction or augmentation of preterm labor |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Bernstein | Montefiore Medical Center | 718-904-2767 | pbernste@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2020 | Jun 30, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 22, 2020 | Jun 30, 2021 | ICF_001.pdf |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Continuity in Readings of Fetal Heart Rate | 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 | Fetal Heart Rate data was not collected and therefore not analyzed | Posted | within 4 hours of device application |
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| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
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