Clinical Feasibility of Birth- Track II System | NCT00840710

Studies
Clinical Feasibility of Birth- Track II System

NCT00840710

Sponsor

Barnev Ltd

Status

Unknown status

Last Update Posted

Dec 29, 2009Estimated

Enrollment

15Estimated

Phase

Not provided

Conditions

Obstetrics
Labor

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Not provided

Completion Date

Aug 2010Estimated

First Submitted Date

Feb 8, 2009

First Submission Date that Met QC Criteria

Feb 9, 2009

First Posted Date

Feb 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2009

Last Update Posted Date

Dec 29, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Women in active labor

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jacob Bornestein, Phd.	Contact	049107207

Overall Officials

Name	Affiliation	Role
Jacob Bornstein, PhD	Westren Gallilie Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Westren Gallilie Hospital		Nahariya			Israel