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

This study has been terminated.
(The study was terimnated - low rate of cases)
Sponsor:
Information provided by:
Barnev Ltd
ClinicalTrials.gov Identifier:
NCT00502918
First received: July 17, 2007
Last updated: December 27, 2009
Last verified: July 2007
  Purpose

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


Condition Intervention
Obstetrics
Labor
Device: CLM - HA Continuous Monitoring System Heart Application

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Feasibility Study -Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application

Further study details as provided by Barnev Ltd:

Primary Outcome Measures:
  • Monitoring fetal heart movement [ Time Frame: During labour ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: February 2008
Study Completion Date: August 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Device: CLM - HA Continuous Monitoring System Heart Application
NA

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502918

Locations
Israel
Tel Aviv Soraski medical center
Tel - Aviv, Israel
Sponsors and Collaborators
Barnev Ltd
Investigators
Principal Investigator: Ariel Many, MD Sackler School od Medicine , Tel Aviv University
  More Information

No publications provided

Responsible Party: Clinical Trial Manager, Barnev Ltd
ClinicalTrials.gov Identifier: NCT00502918     History of Changes
Other Study ID Numbers: TASMC-07-AM-279-CTIL
Study First Received: July 17, 2007
Last Updated: December 27, 2009
Health Authority: Israel: Ethics Commission

ClinicalTrials.gov processed this record on July 31, 2014