Pivotal Study of the Al-Sense Study Protocol

Western Galilee Hospital-Nahariya

Status and phase

Completed

Phase 2

Phase 1

Conditions

Amniotic Fluid Leakage

Treatments

Device: AL-SENSE Diagnostic Absorbent Panty liner

Study type

Interventional

Funder types

Other

Identifiers

NCT00604838

AlSense-Pivot101

Details and patient eligibility

About

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.

Enrollment

330 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.