Clinical Evaluation of New Computerized Labor Monitoring System (CLM)
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 Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Clinical Evaluation of New Computerized Labor Monitoring System.|
|Study Start Date:||June 2007|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Women in active labor
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: NCT00496899
|Tel Aviv soraski medical center|
|Tel - Aviv, Israel, 64239|
|Principal Investigator:||Ariel Many, MD||Sackler school of medicine, Tel Aviv University|