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Clinical Feasibility of Birth- Track II System (BT)

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ClinicalTrials.gov Identifier: NCT00840710
Recruitment Status : Unknown
Verified February 2009 by Barnev Ltd.
Recruitment status was:  Not yet recruiting
First Posted : February 10, 2009
Last Update Posted : December 29, 2009
Sponsor:
Information provided by:

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

Condition or disease
Obstetrics Labor

Study Design

Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical Feasibility of Birth- Track II System
Study Start Date : February 2010
Estimated Study Completion Date : August 2010
Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women in active labor
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840710


Contacts
Contact: Jacob Bornestein, Phd. 049107207

Locations
Israel
Westren Gallilie Hospital Not yet recruiting
Nahariya, Israel
Principal Investigator: Jacob Bornstein, Phd         
Sponsors and Collaborators
Barnev Ltd
Investigators
Principal Investigator: Jacob Bornstein, PhD Westren Gallilie Hospital
More Information

Responsible Party: Clinical Trial Manager, Barnev Ltd
ClinicalTrials.gov Identifier: NCT00840710     History of Changes
Other Study ID Numbers: BT-II-IS-001
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: December 29, 2009
Last Verified: February 2009

Keywords provided by Barnev Ltd:
women in active labor