Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device (EUM)
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About
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.
Full 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.
Enrollment
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Inclusion criteria
- Maternal age >18 years old
- Singleton pregnancy
- Gestational age of 24 completed weeks or greater based on the estimated due date as calculated from last menstrual period or early ultrasound
- Category I (reassuring) fetal heart rate tracing at time of enrollment
Exclusion criteria
- Fetal anomaly or chromosome defect
- Allergy to silver
- Woman with implanted electronic device of any kind
- Irritated skin or open wound on the abdominal wall
Trial design
48 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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