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

NCT ID: NCT00502918

Last Updated: 2009-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-08-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Obstetrics Labor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

CLM - HA Continuous Monitoring System Heart Application

Intervention Type DEVICE

Interventions

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CLM - HA Continuous Monitoring System Heart Application

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Barnev Ltd

OTHER

Sponsor Role lead

Responsible Party

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Barnev Ltd

Principal Investigators

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Ariel Many, MD

Role: PRINCIPAL_INVESTIGATOR

Sackler School od Medicine , Tel Aviv University

Locations

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Tel Aviv Soraski medical center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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TASMC-07-AM-279-CTIL

Identifier Type: -

Identifier Source: org_study_id