Clinical Evaluation of New Computerized Labor Monitoring System

Labor Clinical Trial

— CLM  

Official title:

Clinical Evaluation of New Computerized Labor Monitoring System.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00496899
• Other study ID #: TASMC-07-AM-355-CITL
• Status: Terminated
• Phase: N/A
• First received: July 4, 2007
• Last updated: May 8, 2008
• Start date: June 2007
• Est. completion date: September 2007

Study information

• Verified date: July 2007
• Source: Barnev Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Labor
• Obstetrics

Locations

Country	Name	City	State
Israel	Tel Aviv soraski medical center	Tel - Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Barnev Ltd

Country where clinical trial is conducted

Israel,