Clinical Evaluation of New Computerized Labor Monitoring System (CLM)

This study has been terminated.
(The study was stopped prematurally due to low recruiting)
Sponsor:
Information provided by:
Barnev Ltd
ClinicalTrials.gov Identifier:
NCT00496899
First received: July 4, 2007
Last updated: May 8, 2008
Last verified: July 2007

July 4, 2007
May 8, 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 ClinicalTrials.gov 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
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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1
Women in active labor
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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
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
Female
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00496899
TASMC-07-AM-355-CITL
No
Clinical Trial Manager, Barnev
Barnev Ltd
Not Provided
Principal Investigator: Ariel Many, MD Sackler school of medicine, Tel Aviv University
Barnev Ltd
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP