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

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ClinicalTrials.gov Identifier: NCT00502918
Recruitment Status : Terminated (The study was terimnated - low rate of cases)
First Posted : July 18, 2007
Last Update Posted : December 29, 2009
Sponsor:
Information provided by:
Barnev Ltd

July 17, 2007
July 18, 2007
December 29, 2009
February 2008
July 2008   (Final data collection date for primary outcome measure)
Monitoring fetal heart movement [ Time Frame: During labour ]
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Complete list of historical versions of study NCT00502918 on ClinicalTrials.gov Archive Site
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Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application (HA)
Feasibility Study -Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application
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

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
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample
Laboring women reffered to the maternity center in active labor (3cm - 7 cm) dilataion and contraction
  • Obstetrics
  • Labor
Device: CLM - HA Continuous Monitoring System Heart Application
1
Intervention: Device: CLM - HA Continuous Monitoring System Heart Application
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
10
August 2008
July 2008   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
20 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00502918
TASMC-07-AM-279-CTIL
No
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Clinical Trial Manager, Barnev Ltd
Barnev Ltd
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Principal Investigator: Ariel Many, MD Sackler School od Medicine , Tel Aviv University
Barnev Ltd
July 2007