Pivotal Study of the Al-Sense Study Protocol

Completed · Phase 1/Phase 2

Conditions studied: Amniotic Fluid Leakage

In brief

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.

Key facts

Study ID: NCT00604838
Run by: Western Galilee Hospital-Nahariya
People needed: 330
Starts: 2006-05-01
Expected to finish: 2006-11-01
Last updated by the study team: 2008-01-30

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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.

Where it is running

Wayne State University / Hutzel Women's Hospital — Detroit, Michigan, United States
Western Galilee Hospital-Nahariya — Nahariya, Israel

Full record on ClinicalTrials.gov

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