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

Brief Summary:
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.

Condition or disease
Obstetrics Labor

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical Evaluation of New Computerized Labor Monitoring System.
Study Start Date : June 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Women in active labor

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Laboring women reffered to maternity center in active labor (3 -7 cm)dilatation and contraction

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

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 identifier (NCT number): NCT00496899

Tel Aviv soraski medical center
Tel - Aviv, Israel, 64239
Sponsors and Collaborators
Barnev Ltd
Principal Investigator: Ariel Many, MD Sackler school of medicine, Tel Aviv University

Responsible Party: Clinical Trial Manager, Barnev Identifier: NCT00496899     History of Changes
Other Study ID Numbers: TASMC-07-AM-355-CITL
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: May 9, 2008
Last Verified: July 2007

Keywords provided by Barnev Ltd:
cervical dilatation