Measuring Uterine Electrical Activity Throughout Pregnancy and Labor Measuring Uterine Electrical Activity Throughout Pregnancy and Labor

• Conditions: Pregnancy

• Registration Number: NCT01165879
• Lead Sponsor: OB-Tools Ltd.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2010-05
• Status Verified: 2010-07
• Study First Submitted: 2010-07-18
• Study First Submitted QC: 2010-07-18
• Study First Posted: 2010-07-20
• Last Update Submitted: 2011-06-09
• Last Update Posted: 2011-06-10
• Primary Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Women at term with complaint of uterine contractions at Meir Medical Center
• Women at preterm with complaint of uterine contractions at Meir Medical Center.
• Women at gestational age >24 weeks
• Subjects who understood, agreed and signed the informed consent form

Exclusion Criteria

• Subjects who refused to sign the informed consent form
• Abnormal fetal heart rate recording at admittance
• Subjects with indications for immediate delivery
• Subjects younger than 18 years of age
• Subjects at gestational age <24 weeks

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	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	one year	Measurements of device related adverse events throughout the study.

Secondary Outcome Measures

Name	Time	Method
Correlation of uterine contractions intensity between EUM100pro and Intra Uterine Pressure Catheter measurements.	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	one year
to evaluate whether a fetal ECG can be exctraced from the electrical signal of the uterus.	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.

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel