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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by OB-Tools Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
OB-Tools Ltd.
ClinicalTrials.gov Identifier:
NCT01165879
First received: July 18, 2010
Last updated: June 9, 2011
Last verified: July 2010
  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 ] [ 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.


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Tal Biron Shental, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01165879     History of Changes
Other Study ID Numbers: HTA5347
Study First Received: July 18, 2010
Last Updated: June 9, 2011
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 18, 2014