Clinical Feasibility of Birth- Track II System (BT)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by Barnev Ltd.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Barnev Ltd

ClinicalTrials.gov Identifier:

NCT00840710

First received: February 8, 2009

Last updated: December 27, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 8, 2009

Last Updated Date

December 27, 2009

Start Date ^ICMJE

February 2010

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00840710 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Clinical Feasibility of Birth- Track II System

Official Title ^ICMJE

Clinical Feasibility of Birth- Track II System

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Women in active labor

Condition ^ICMJE

Obstetrics
Labor

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2010

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Laboring women referred to the Maternity Center in active labor (3cm dilatation and contractions).
Gestational age 37-42 weeks. (GA)
Single fetus
Subjects who understood, agreed and signed the informed consent form

Exclusion Criteria:

Women with abnormal placentation (placenta previa)
Abnormal fetal presentation (breech presentation)
Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes.
Need for immediate delivery (cord prolapsed or suspected placental abruption)

Gender

Female

Ages

17 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Jacob Bornestein, Phd.

049107207

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00840710

Other Study ID Numbers ^ICMJE

BT-II-IS-001

Has Data Monitoring Committee

Responsible Party

Clinical Trial Manager, Barnev Ltd

Study Sponsor ^ICMJE

Barnev Ltd

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jacob Bornstein, PhD

Westren Gallilie Hospital

Information Provided By

Barnev Ltd

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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