Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application (HA)
Device: CLM - HA Continuous Monitoring System Heart Application
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Feasibility Study -Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application|
- Monitoring fetal heart movement [ Time Frame: During labour ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||August 2008|
|Estimated Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
|1||Device: CLM - HA Continuous Monitoring System Heart Application|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502918
|Tel Aviv Soraski medical center|
|Tel - Aviv, Israel|
|Principal Investigator:||Ariel Many, MD||Sackler School od Medicine , Tel Aviv University|