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
  Purpose

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


Condition
Obstetrics
Labor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical Feasibility of Birth- Track II System

Further study details as provided by Barnev Ltd:

Estimated Enrollment: 15
Study Start Date: February 2010
Estimated Study Completion Date: August 2010
  Eligibility

Ages Eligible for Study:   17 Years to 50 Years
Genders 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
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: 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

No publications provided

Responsible Party: Clinical Trial Manager, Barnev Ltd
ClinicalTrials.gov Identifier: NCT00840710     History of Changes
Other Study ID Numbers: BT-II-IS-001
Study First Received: February 8, 2009
Last Updated: December 27, 2009
Health Authority: Israel: Ethics Commission

Keywords provided by Barnev Ltd:
women in active labor

ClinicalTrials.gov processed this record on August 28, 2014