Pivotal Study of the Rx Al-Sense Liner

This study is designed to demonstrate that the performance of the AL-SENSE developed by
Common Sense Ltd. is safe and effective and can be used to indicate if the patient may be
experiencing an amniotic fluid leakage or a "water breaking". The AL-SENSE is a regular
absorbent panty liner to be used as any other hygienic absorbent panty liner. The only
significant difference, as far as the user is concerned, is the ability to indicate amniotic
fluid leaks by visual color changes.

The AL-SENSE is an extended shelf-life product that is technically simple, fast to react,
visually readable, and therefore enables women to test the cause of any unidentified
wetness, before confirmation by a physician.

Principles of operation:

Vaginal fluids are discharged over time and collected on the non-intrusive panty liner. If
the user observes a blue or green stain, the result of the test is positive. The AL-SENSE
polymer matrix is stained by blue or green color on a pale yellow background when the pH
level of the fluid in contact with it is greater than the cutoff value.

The AL-SENSE will indicate that the pH level is elevated when the level is equal or greater
than 6.5. This choice of 6.5 units as the cutoff level will limit the cases of false
positive and will reduce unnecessary alarm.

Summary of Study Design

Purpose: To demonstrate that the Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak
Test Kit), developed by Common Sense Ltd., can indicate whether wetness sensed by pregnant
women may be caused by amniotic fluid leakage rather than by urinary incontinence. An
additional, secondary objective is to show that the AL-SENSE performance, sensitivity and
specificity, is Substantially Equivalent to those specified for the currently marketed
AmniScreen. User readings will be compared to trained personnel readings to prove the
effectiveness of the AL-SENSE as a home or hospital-based test.

Design: Prospective open-label, comparative pivotal study with comparison of
self-assessments with blinded investigator assessments.

Patient Population: Pregnant women, ages 18 and above.

Baseline/ Screening

Subjects attending the labor and delivery unit of the hospital or emergency clinic and
reporting unidentified wetness (undetermined whether this is amniotic fluid leakage or
urinary incontinence) will be enrolled in this study. After informed consent is obtained,
each subject will be given a single AL-SENSE to use up to 12 hours or until the perception
of wetness. The clinician will explain the proper use and handling of the AL-SENSE and how
to read the result. The participants will be provided with instructions for use and also
directed to read the Instructions For Use (IFU) prior to applying the AL-SENSE pad.

Product Usage

After usage, the subject will read and record any occurrence of color change of the AL-SENSE
10 minutes after the liner removal and to mark if it changes color to blue or to green or
not on the designated form.. The used liner will be placed in a separate sealed envelope
with the subject's ID and product name and protocol number on the outside.

The subjects will fill out the questionnaire regarding the product usage experience and the
liner color reading with no help from the investigator, to validate IFU reading
comprehension. The completed form will be placed in a sealed envelope with the subject's
initials and study number on the outside.

Clinical Diagnosis

A blinded clinician will perform a "standard clinical diagnosis" (clinical assessment), and
record the results on a worksheet to be included in the case report form. The standard
clinical diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning
test, (3) pH test by pH paper. A positive Pooling test and/or positive results in both the
pH test and the Ferning test will be defined as a positive clinical test result.

The subject is expected to remain at the hospital for the duration of the test for
completing the "standard clinical diagnosis" tests, required by the protocol. Although the
performance of the AL-SENSE is examined in this study, subject treatment will be based only
on the standard hospital diagnostic methods.

Inclusion Criteria:

Screening/ Baseline inclusion criteria for subject participation in the study at baseline
assessment are pregnant women age 18 and above who have completed minimum 16 weeks of
pregnancy are eligible for the study. Subject attending the labor and delivery unit of the
hospital or emergency clinic or outpatient clinic and reporting a feeling of vaginal
wetness feeling (undetermined whether this is amniotic fluid leakage or urinary
incontinence)