AL-SENSE 1-Step - Determination of Product Specificity (ROM)

March 4, 2013 updated by: Common Sense
Clinical diagnosis of amniotic fluid leak will be determined, according the hospital standard procedure, using pooling test and/or sterile speculum examination and /or pH test, and AmniSure, N-Dia, Inc. (immunoassay for diagnosis of ruptured fetal membranes (ROM)). Amniotic fluid leak test, using the AL- SENSE 1-Step device, will be considered positive in case of presence of a blue or green or grey stain on a yellow background of the AL-SENSE 1-Step, as observed by the patient and the clinician (positive/negative).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Pregnant women arriving at the hospital and reporting unidentified wetness (undetermined whether they sense amniotic fluid leakage or urinary incontinence) will receive a single AL-SENSE 1-Step to use up to 12 hours or until they notice any wetness. The clinician will explain the proper use and handling of the AL-SENSE 1-Step and how to read the result.

In each case, the subject and the clinician/midwife (non bias to the hospital standard procedure results) will be required to read and record any occurrence of color change of the AL-SENSE 1-Step immediately after removing the test to mark if it changes color to blue or to green or to grey on the designated form.

The non bias physician, who is not aware to the AL-SENSE 1-Step result (other than the clinician/midwife who records the AL-SENSE 1-Step results) will perform a diagnosis tests for amniotic fluid leak detection, according to the hospital standard procedure.

The investigator will compare the AL-SENSE 1-Step results reading of the patient to the clinical diagnosis.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Israel
      • Nahariya, Israel
        • Western Galilee Hospital

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. AgE 18 years OR GREATER.
  2. Subject who will sign the informed consent form.
  3. Subject who arrive at the obstetric department reporting a feeling of vaginal wetness feeling (undetermined whether she sense amniotic fluid leakage or urinary incontinence).

Exclusion Criteria:

  1. Subjects that have had sexual relations within the last 12 hours.
  2. Subject is unable or unwilling to cooperate with study procedures.
  3. Subject is currently participating in another clinical study

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AL-SENSE 1-Step
a single AL-SENSE 1-Step to use up to 12 hours or until they notice any wetness.
Device: AL-SENSE 1-Step
a single AL-SENSE 1-Step to use up to 12 hours or until they notice any wetness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
amniotic fluid leaks
Time Frame: up to 12 hours
up to 12 hours

Collaborators and Investigators

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

Sponsor

Common Sense

Investigators

  • Principal Investigator: Jacob Bornstain, MD, Western Galilee Hospital Nahariya, Israel

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

April 1, 2013

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

March 4, 2013

First Posted (Estimate)

March 5, 2013

Study Record Updates

Last Update Posted (Estimate)

March 5, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-7-32.2-1
  • 0096-12-NHR (Registry Identifier: Helsinky committee)

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.

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