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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by OB-Tools Ltd..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01165879
First Posted: July 20, 2010
Last Update Posted: June 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
OB-Tools Ltd.
  Purpose
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.

Condition
Pregnancy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective

Further study details as provided by OB-Tools Ltd.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pergnant women which are admitted to Meir Medical Center with complaints of uterine contractions starting.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Tal Shental Biron, MD 972-577482716 Tal.Biron-Shental@clalit.org.il

Locations
Israel
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         
Sponsors and Collaborators
OB-Tools Ltd.
Investigators
Principal Investigator: Tal Shental Biron, MD "Meir" Hospital
  More Information

Responsible Party: Dr. Tal Biron Shental, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01165879     History of Changes
Other Study ID Numbers: HTA5347
First Submitted: July 18, 2010
First Posted: July 20, 2010
Last Update Posted: June 10, 2011
Last Verified: July 2010

Keywords provided by OB-Tools Ltd.:
Pregnancy
Term
Preterm
Uterine Contractions