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

Common Sense Ltd.

Status: Unknown

Conditions: PREMATURE RUPTURE OF MEMBRANES

Treatments: Device: AL-SENSE 1-Step

Study type: Interventional

Funder types: Other

Identifiers

NCT01804348

F-7-32.2-1

0096-12-NHR (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

---

150 participants in 1 patient group

AL-SENSE 1-Step

Experimental group

Description:

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

Treatment:

Device: AL-SENSE 1-Step