Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00496899
Status:
TERMINATED
Last Update Posted:
2008-05-09
First Post:
2007-07-04
Brief Title:
Clinical Evaluation of New Computerized Labor Monitoring System
Sponsor:
Barnev Ltd
Organization:
Barnev Ltd
Study Overview
Official Title:
Clinical Evaluation of New Computerized Labor Monitoring System
Status:
TERMINATED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped prematurally due to low recruiting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLM
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
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 babys 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None