Pivotal Study of the Al-Sense Study Protocol

This study has been completed.
Sponsor:
Information provided by:
Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT00604838
First received: January 17, 2008
Last updated: January 29, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Amniotic Fluid Leakage
Device: AL-SENSE Diagnostic Absorbent Panty liner
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pivotal Study of the Al-ASense Study Protocol

Resource links provided by NLM:


Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • presence or absence of a blue-green stain on a yellow background as yielded by the AL-SENSE and observed by the patient. [ Time Frame: up to 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: up to 12 hours ] [ Designated as safety issue: No ]

Enrollment: 330
Study Start Date: May 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I Device: AL-SENSE Diagnostic Absorbent Panty liner
worn for 12 hours
Other Name: AL-SENSE Amniotic Leak Test Kit
Device: AL-SENSE Diagnostic Absorbent Panty liner
Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd worn for 12 hours

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604838

Locations
United States, Michigan
Wayne State University / Hutzel Women's Hospital
Detroit, Michigan, United States, 48201
Israel
Western Galilee Hospital-Nahariya
Nahariya, Israel, 22100
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Investigators
Principal Investigator: Jacob Bornstein, MD Western Galilee Hospital-Nahariya
Principal Investigator: Yoram Sorokin, MD Wayne State University / Hutzel Women's Hospital