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

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 Overview

• Status: Unknown
• Conditions: Pregnancy

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Tal Shental Biron, MD; Phone Number: 972-577482716; Email: Tal.Biron-Shental@clalit.org.il

Study Locations

• Israel
  • Kfar Saba, Israel, 44281
    • Recruiting
    • Meir Medical Center
    • Contact: Tal Shental Biron, MD; Phone Number: +972-577482716; Email: Tal.Biron-Shental@clalit.org.il
    • Principal Investigator: Tal Shental Biron, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pergnant women which are admitted to Meir Medical Center with complaints of uterine contractions starting.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
To evaluate patient safety	Measurements of device related adverse events throughout the study.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
To evaluate usability of the EUM100pro		one year
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

Collaborators and Investigators

• Sponsor: OB-Tools Ltd.
• Investigators: Principal Investigator: Tal Shental Biron, MD, Meir Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): May 1, 2012
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: July 18, 2010
• First Submitted That Met QC Criteria: July 18, 2010
• First Posted (Estimate): July 20, 2010

Study Record Updates

• Last Update Posted (Estimate): June 10, 2011
• Last Update Submitted That Met QC Criteria: June 9, 2011
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Pregnancy; Term; Preterm; Uterine Contractions
• Other Study ID Numbers: HTA5347

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No