Pivotal Study of the AL-SENSE in Diagnosis Amniotic Fluid Leakage
Condition: AMNIOTIC FLUID LEAKAGE
Study type: Observational

Summary: 
      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 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. An additional,
      secondary objective is to show that the AL-SENSE is associated with levels of sensitivity and
      specificity that are comparable to those specified for the currently marketed AMNIOTESTTM
      (nitrazine yellow swabs; PRO LAB Diagnostics) product.
    

Detailed description: 
      Baseline/ Screening

      Potential subjects may undergo the informed consent process in the outpatient clinic.

      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) Nitrazine paper or pH paper test. A positive Pooling test and/or
      positive results in both the Nitrazine or pH test and the Ferning test will be defined as a
      positive clinical test result for amniotic fluid.

      Although the preferred sequence is using the liner before clinical diagnosis, diagnostic
      procedures may be done before liner use, as long as lubricants are not used for procedures.
      The use of lubricants interferes with the accuracy of liner reaction to amniotic fluid.

      If the liner is removed for clinical testing before sufficient fluid has collected, it may
      either be reused or a fresh liner may be dispensed. Note that any use of lubricants
      contraindicates further usage of Al-Sense.

      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.

      A positive Pooling test or positive results in the other 2 tests is defined as a positive
      clinical assessment.

      Although the performance of the AL-SENSE is examined in this study, subject treatment will be
      based only on the standard hospital diagnostic methods.
    

Intervention name(s): AL-SENSE
Intervention type(s): Device
Intervention description(s): The AL-SENSE reacts differently when in contact with amniotic fluid than it does with urine. The indicator changes color to blue-green and fades back to yellow in case of urine and changes to stable blue-green in case of amniotic fluid.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Pregnant women arriving at the hospital and reporting unidentified wetness
      
Biospecimen description: 
      vaginal fluids