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

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

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

Study Overview

• Status: Terminated
• Conditions: Labor; Obstetrics
• Intervention / Treatment: Device: CLM - HA Continuous Monitoring System Heart Application

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 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.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• Israel
  • Tel - Aviv, Israel
    • Tel Aviv soraski medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Laboring women reffered to the maternity center in active labor (3cm - 7 cm) dilataion and contraction

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1	Device: CLM - HA Continuous Monitoring System Heart Application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Monitoring fetal heart movement	During labour

Collaborators and Investigators

• Sponsor: Barnev Ltd
• Investigators: Principal Investigator: Ariel Many, MD, Sackler School od Medicine , Tel Aviv University

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Anticipated): July 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: July 17, 2007
• First Submitted That Met QC Criteria: July 17, 2007
• First Posted (Estimate): July 18, 2007

Study Record Updates

• Last Update Posted (Estimate): December 29, 2009
• Last Update Submitted That Met QC Criteria: December 27, 2009
• Last Verified: July 1, 2007

More Information

Terms related to this study

• Other Study ID Numbers: TASMC-07-AM-279-CTIL