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

Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00502918
• Other study ID #: TASMC-07-AM-279-CTIL
• Status: Terminated
• Phase: N/A
• First received: July 17, 2007
• Last updated: December 27, 2009
• Start date: February 2008
• Est. completion date: August 2008

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 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

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: August 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Laboring women refered to the maternity center in active labor (3cm dilatation and contraction)

2. Gestational age 37-42 weeks. (GA)

3. Single Fetus.

4. Subjects who understand, agreed and signed the informed consent form.

Exclusion Criteria:

1. Women with abnormal placentation (Placenta previa) -

2. Abnormal fetal presentation (Breech presentation).

3. Maternal History of HIV and/or blood transmitted Hepatitis and /or active genital Herpes.

4. 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

Intervention

Device:
• CLM - HA Continuous Monitoring System Heart Application

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monitoring fetal heart movement		During labour	No