Measuring Uterine Electrical Activity Throughout Pregnancy and Labor Measuring Uterine Electrical Activity Throughout Pregnancy and Labor
Recruitment status was Recruiting
The EUM100pro (Electrical Uterine Monitor)is a uterine contraction monitor which measures uterine contractions based on the electrical activity of the uterine muscle.The study will compare the EUM100pro measurements to the already existing uterine contractions monitors (tocodynamometer and Intra Uterine Pressure Catheter) in pregnant women with complaints of uterine contractions.
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- to evaluate whether a fetal ECG can be exctraced from the electrical signal of the uterus. [ Time Frame: one year ] [ Designated as safety issue: No ]The electrical signal recorded from the abdomen thechnically contain the uterine muscle electrical activity but also the electrical signal from the fetal ecg.
|Study Start Date:||May 2010|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|