Clinical Feasibility of Birth- Track II System
BT
1 other identifier
observational
15
1 country
1
Brief Summary
The Study purpose is to monitor the cervix dilation, head descent, FHR and to follow contraction in a women in active labor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2009
CompletedFirst Posted
Study publicly available on registry
February 10, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedDecember 29, 2009
February 1, 2009
February 8, 2009
December 27, 2009
Conditions
Keywords
Eligibility Criteria
Women in active labor
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Barnev Ltdlead
Study Sites (1)
Westren Gallilie Hospital
Nahariya, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob Bornstein, PhD
Westren Gallilie Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 8, 2009
First Posted
February 10, 2009
Study Start
February 1, 2010
Study Completion
August 1, 2010
Last Updated
December 29, 2009
Record last verified: 2009-02