Clinical Evaluation of New Computerized Labor Monitoring System (CLM)

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. Identifier: NCT00496899
Recruitment Status : Terminated (The study was stopped prematurally due to low recruiting)
First Posted : July 6, 2007
Last Update Posted : May 9, 2008
Information provided by:
Barnev Ltd

July 4, 2007
July 6, 2007
May 9, 2008
June 2007
September 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00496899 on Archive Site
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Clinical Evaluation of New Computerized Labor Monitoring System
Clinical Evaluation of New Computerized Labor Monitoring System.
The study is an open label feasibility study. The purpose of the study is to evaluate the ease of use of the Cervical ITR in terms of duration of attachment and number of detachments.

Every year, millions of babies are born worldwide. Yet, despite great advances in medical technology, the method used to obtain the most critical parameter in labor management - cervix dilatation, remains a vaginal (manual) examination. This vaginal examination, intended to estimate the dilatation of the cervix and the progress of the baby's head, is inaccurate, non-continuous and involves the risk of infection to both fetus and mother. It is also uncomfortable to the mother. The consequences of infections or delayed treatment may range from simple complications to irreversible damage. Early detection of abnormal patterns of labor progress could prevent complications and shorten the labor process and hospitalization, thereby saving both aggravation and cost.

To truly manage the labor process, a labor management system is required. Such a system is expected to provide the obstetrical staff with the flow of accurate, continuous, real-time information, such as cervix dilatation.

Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample
Laboring women reffered to maternity center in active labor (3 -7 cm)dilatation and contraction
  • Obstetrics
  • Labor
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Women in active labor
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2007
September 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Laboring women referred to the Maternity Center in active labor (3cm dilatation and contractions).
  • Gestational age 37-42 weeks. (GA)
  • Single fetus
  • Subjects who understood, agreed and signed the informed consent form

Exclusion Criteria:

  • Women with abnormal placentation (placenta previa)
  • Women with coagulation abnormalities.
  • Abnormal fetal presentation (breech presentation)
  • Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes.
  • Preterm premature rupture of membranes.
  • Need for immediate delivery (cord prolapsed or suspected placental abruption
Sexes Eligible for Study: Female
20 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Clinical Trial Manager, Barnev
Barnev Ltd
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Principal Investigator: Ariel Many, MD Sackler school of medicine, Tel Aviv University
Barnev Ltd
July 2007