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NCT00840710 Clinical Trial

Clinical Feasibility of Birth- Track II System

Labor Clinical Trial

— BT  

Official title:
Clinical Feasibility of Birth- Track II System

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00840710
Other study ID # BT-II-IS-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 8, 2009
Last updated December 27, 2009
Start date February 2010
Est. completion date August 2010

Study information
Verified date February 2009
Source Barnev Ltd
Contact Jacob Bornestein, Phd.
Phone 049107207
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 15
Est. completion date August 2010
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 17 Years to 50 Years
Eligibility 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)

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Westren Gallilie Hospital Nahariya

Sponsors (1)
Lead Sponsor Collaborator
Barnev Ltd

Country where clinical trial is conducted

Israel, 

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