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Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application (HA)

This study has been terminated.
(The study was terimnated - low rate of cases)
Information provided by:
Barnev Ltd Identifier:
First received: July 17, 2007
Last updated: December 27, 2009
Last verified: July 2007
The study is a feasibility study to check the possibility of tracking the heart rate of the fetus and to translate the outcome to the progress of the labor

Condition Intervention
Obstetrics Labor Device: CLM - HA Continuous Monitoring System Heart Application

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Feasibility Study -Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application

Further study details as provided by Barnev Ltd:

Primary Outcome Measures:
  • Monitoring fetal heart movement [ Time Frame: During labour ]

Enrollment: 3
Study Start Date: February 2008
Study Completion Date: August 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Device: CLM - HA Continuous Monitoring System Heart Application

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.


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 the maternity center in active labor (3cm - 7 cm) dilataion and contraction

Inclusion Criteria:

  1. Laboring women refered to the maternity center in active labor (3cm dilatation and contraction)
  2. Gestational age 37-42 weeks. (GA)
  3. Single Fetus.
  4. Subjects who understand, agreed and signed the informed consent form.

Exclusion Criteria:

  1. Women with abnormal placentation (Placenta previa) -
  2. Abnormal fetal presentation (Breech presentation).
  3. Maternal History of HIV and/or blood transmitted Hepatitis and /or active genital Herpes.
  4. Need for immediate delivery (cord prolapsed or suspected placental abruption)
  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 identifier: NCT00502918

Tel Aviv Soraski medical center
Tel - Aviv, Israel
Sponsors and Collaborators
Barnev Ltd
Principal Investigator: Ariel Many, MD Sackler School od Medicine , Tel Aviv University
  More Information

Responsible Party: Clinical Trial Manager, Barnev Ltd Identifier: NCT00502918     History of Changes
Other Study ID Numbers: TASMC-07-AM-279-CTIL
Study First Received: July 17, 2007
Last Updated: December 27, 2009 processed this record on September 20, 2017