NCT00502918

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Barnev Ltd · Academic / Other
• Sex: Female
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Obstetrics
• Labor

Interventions

Type	Name	Description
DEVICE	CLM - HA Continuous Monitoring System Heart Application

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-07-01
• Completion: 2008-08-01
• First posted: 2007-07-18
• Last updated: 2009-12-29

Locations

1 site across 1 country: Israel