Clinical Feasibility of Birth- Track II System (BT)

December 27, 2009 updated by: Barnev Ltd
The Study purpose is to monitor the cervix dilation, head descent, FHR and to follow contraction in a women in active labor.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jacob Bornestein, Phd.
  • Phone Number: 049107207

Study Locations

  • Israel
      • Nahariya, Israel
        • Westren Gallilie Hospital
        • Principal Investigator:
          • Jacob Bornstein, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women in active labor

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barnev Ltd

Investigators

  • Principal Investigator: Jacob Bornstein, PhD, Westren Gallilie Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

February 8, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimate)

February 10, 2009

Study Record Updates

Last Update Posted (Estimate)

December 29, 2009

Last Update Submitted That Met QC Criteria

December 27, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BT-II-IS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Labor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe