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Clinical Evaluation of New Computerized Labor Monitoring System (CLM)

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ClinicalTrials.gov 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
Sponsor:
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

Group/Cohort
1
Women in active labor




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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00496899


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

Responsible Party: Clinical Trial Manager, Barnev
ClinicalTrials.gov 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:
Labor
Obstetric
cervical dilatation