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NCT02993354 · ClinicalTrials.gov registry record
Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device
A clinical trial, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- 48
- Enrollment target
NCT02993354: Completed study, sponsored by Montefiore Medical Center.
NCT02993354 is a clinical trial that has completed, run by Montefiore Medical Center. The registered enrollment target is 48 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02993354 has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- 48 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE The EUM300 (electrical uterine myography)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2021-09-21 |
What the finished NCT02993354 record still lists
NCT02993354 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 48 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which The EUM300 (electrical uterine myography) is the first listed.
NCT02993354 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02993354 about?
NCT02993354 is a clinical study titled "Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device". 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 t...
What is the current status of trial NCT02993354?
This trial is currently completed. The enrollment target is 48 participants. The study started on 2017-07-01. Estimated completion is 2021-09-21.
What interventions are being tested in trial NCT02993354?
The interventions under investigation include: The EUM300 (electrical uterine myography) (DEVICE).
Who is sponsoring clinical trial NCT02993354?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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