Clinical Evaluation of New Computerized Labor Monitoring System (CLM)

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.

Study Overview

• Status: Terminated
• Conditions: Labor; Obstetrics

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
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• Israel
  • Tel - Aviv, Israel, 64239
    • Tel Aviv soraski medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Laboring women reffered to maternity center in active labor (3 -7 cm)dilatation and contraction

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Women in active labor

Collaborators and Investigators

• Sponsor: Barnev Ltd
• Investigators: Principal Investigator: Ariel Many, MD, Sackler school of medicine, Tel Aviv University

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: July 4, 2007
• First Submitted That Met QC Criteria: July 4, 2007
• First Posted (Estimate): July 6, 2007

Study Record Updates

• Last Update Posted (Estimate): May 9, 2008
• Last Update Submitted That Met QC Criteria: May 8, 2008
• Last Verified: July 1, 2007

More Information

Terms related to this study

• Keywords: Labor; Obstetric; cervical dilatation
• Other Study ID Numbers: TASMC-07-AM-355-CITL