AL-SENSE 1-Step - Determination of Product Specificity

PREMATURE RUPTURE OF MEMBRANES Clinical Trial

— ROM  

Official title:

AL-SENSE 1-Step - Determination of Product Specificity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01804348
• Other study ID #: F-7-32.2-1
• Secondary ID: 0096-12-NHR
• Status: Not yet recruiting
• Phase: N/A
• First received: February 19, 2013
• Last updated: March 4, 2013
• Start date: April 2013
• Est. completion date: August 2013

Study information

• Verified date: November 2012
• Source: Common Sense
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: the israeli national institue for health policy research and health services research.
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• PREMATURE RUPTURE OF MEMBRANES

Intervention

Device:
• AL-SENSE 1-Step
a single AL-SENSE 1-Step to use up to 12 hours or until they notice any wetness.

Locations

Country	Name	City	State
Israel	Western Galilee Hospital	Nahariya

Sponsors (1)

Lead Sponsor	Collaborator
Common Sense

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amniotic fluid leaks		up to 12 hours	Yes