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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00502918
First Posted: July 18, 2007
Last Update Posted: December 29, 2009
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:
Barnev Ltd
  Purpose
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.

  Eligibility

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

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
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): NCT00502918


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

Responsible Party: Clinical Trial Manager, Barnev Ltd
ClinicalTrials.gov Identifier: NCT00502918     History of Changes
Other Study ID Numbers: TASMC-07-AM-279-CTIL
First Submitted: July 17, 2007
First Posted: July 18, 2007
Last Update Posted: December 29, 2009
Last Verified: July 2007