Pivotal Study of the Al-Sense Study Protocol

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that the Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd., can distinguish between wetness sensed by pregnant women that is caused by amniotic fluid leakage and that which is caused by urinary incontinence.

Official Title
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Pivotal Study of the Al-ASense Study Protocol

Conditions
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Amniotic Fluid Leakage

Intervention / Treatment
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* Device: AL-SENSE Diagnostic Absorbent Panty liner
* Device: AL-SENSE Diagnostic Absorbent Panty liner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 to 45 years. minimum 16 weeks of pregnancy. willing to sign the informed consent form. arrived at the obstetric department reporting a feeling of vaginal wetness (undetermined whether this is amniotic fluid leakage or urinary incontinence). Exclusion Criteria: experienced intermittent vaginal bleeding between the 2nd and 3rd trimester. have had sexual relations within the last 12 hours. unable or unwilling to cooperate with study procedures. used the AL-SENSE before joining this study. diagnosed with Bacterial Vaginosis or Trichomonas infection within the last 3 days. uses vaginal products such as some douching formulas, some antibiotic treatments which reduce lactobacillus population. uses drugs which reduce estrogen level such as tamoxifen or drugs that dry out the mucous membranes, such as antihistamines on a diet of alkalizing foods such as Alkalive™ Green, which may cause elevation of the vaginal pH level.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br> | Device: AL-SENSE Diagnostic Absorbent Panty liner<br>* worn for 12 hours<br>* Other names: AL-SENSE Amniotic Leak Test Kit;Device: AL-SENSE Diagnostic Absorbent Panty liner<br>* Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd worn for 12 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence or absence of a blue-green stain on a yellow background as yielded by the AL-SENSE and observed by the patient. |  | up to 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence or absence of a blue-green stain on a yellow background as yielded by the AL-SENSE and observed by the clinician and a measurement of patient comfort while using AL-SENSE and reading the results. |  | up to 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amniotic fluid leakage, urinary incontinence, pregnancy, home test, vaginal wetness