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Clinical Feasibility of Birth- Track II System

NCT ID: NCT00840710

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

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-08-31

Brief Summary

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The Study purpose is to monitor the cervix dilation, head descent, FHR and to follow contraction in a women in active labor.

Detailed Description

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Conditions

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Obstetrics Labor

Keywords

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women in active labor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

1. Laboring women referred to the Maternity Center in active labor (3cm dilatation and contractions).
2. Gestational age 37-42 weeks. (GA)
3. Single fetus
4. Subjects who understood, 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

17 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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Jacob Bornstein, PhD

Role: PRINCIPAL_INVESTIGATOR

Westren Gallilie Hospital

Locations

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Westren Gallilie Hospital

Nahariya, , Israel

Site Status

Countries

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Israel

Central Contacts

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Jacob Bornestein, Phd.

Role: CONTACT

Phone: 049107207

Other Identifiers

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BT-II-IS-001

Identifier Type: -

Identifier Source: org_study_id