Measuring Uterine Electrical Activity Throughout Pregnancy and Labor Measuring Uterine Electrical Activity Throughout Pregnancy and Labor
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|ClinicalTrials.gov Identifier: NCT01165879|
Recruitment Status : Unknown
Verified July 2010 by OB-Tools Ltd..
Recruitment status was: Recruiting
First Posted : July 20, 2010
Last Update Posted : June 10, 2011
|Condition or disease|
The main objective of the study is to demonstrate that the EUM100pro is as good as the current methods for monitoring pregnancy in labor (tocodynamometer, IUPC) in measuring uterine contractions. This will be performed by measuring the expectancy of time differences between the tocodynamometer/IUPC and the EUM in the beginning, end, peak and duration of each contraction. A good correlation will be 0.9 and significance of 95%.
100 women will be recruited to the study. The measurement with the EUM100pro will not interfere with the usual clinical care, meaning- the EUM100pro will be used in addition to the standard care and monitoring.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Case Control|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||May 2012|
- The study primary outcome is to demonstrate that the EUM100pro uterine contractions measurements is as good as the current methods for monitoring pregnancy in labor (tocodynamometer, IUPC). [ Time Frame: two years ]The primary outcome will be measured by correlation of timing of :peak display in beginning, during and end of peak in the EUM100pro versus the timing of the peak display in beginning, during and the end tocodynamometer and or IUPC peak.
- To evaluate patient safety [ Time Frame: one year ]Measurements of device related adverse events throughout the study.
- Correlation of uterine contractions intensity between EUM100pro and Intra Uterine Pressure Catheter measurements. [ Time Frame: one year ]The secondary outcome will investigate a correlation between the intensity/peak of contraction of mechanical contraction as measured by Intra Uterine pressure catheter and the intensity/peak of contraction of electrical activity as measured by the EUM exists.
- To evaluate usability of the EUM100pro [ Time Frame: one year ]
- to evaluate whether a fetal ECG can be exctraced from the electrical signal of the uterus. [ Time Frame: one year ]The electrical signal recorded from the abdomen thechnically contain the uterine muscle electrical activity but also the electrical signal from the fetal ecg.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01165879
|Contact: Tal Shental Biron, MD||972-577482716||Tal.Biron-Shental@clalit.org.il|
|Meir Medical Center||Recruiting|
|Kfar Saba, Israel, 44281|
|Contact: Tal Shental Biron, MD +972-577482716 Tal.Biron-Shental@clalit.org.il|
|Principal Investigator: Tal Shental Biron, MD|
|Principal Investigator:||Tal Shental Biron, MD||"Meir" Hospital|