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

Pregnancy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01165879
• Other study ID #: HTA5347
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2010
• Last updated: June 9, 2011
• Start date: May 2010

Study information

• Verified date: July 2010
• Source: OB-Tools Ltd.
• Contact: Tal Shental Biron, MD
• Phone: 972-577482716
• Email: Tal.Biron-Shental[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
OB-Tools Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.	two years	No
Primary	To evaluate patient safety	Measurements of device related adverse events throughout the study.	one year	Yes
Secondary	Correlation of uterine contractions intensity between EUM100pro and Intra Uterine Pressure Catheter measurements.	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.	one year	No
Secondary	To evaluate usability of the EUM100pro		one year	No
Secondary	to evaluate whether a fetal ECG can be exctraced from the electrical signal of the uterus.	The electrical signal recorded from the abdomen thechnically contain the uterine muscle electrical activity but also the electrical signal from the fetal ecg.	one year	No