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Pivotal Study of the Al-Sense Study Protocol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604838
First Posted: January 30, 2008
Last Update Posted: January 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Western Galilee Hospital-Nahariya
  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: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pivotal Study of the Al-ASense Study Protocol

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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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