Pivotal Study of the Al-Sense Study Protocol - Full Text View

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:

MedlinePlus related topics: Urinary Incontinence

U.S. FDA Resources

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

More Information

Publications:

Watanabe T, Minakami H, Itoi H, Sato I, Sakata Y, Tamada T. Evaluation of latex agglutination test for alpha-fetoprotein in diagnosing rupture of fetal membranes. Gynecol Obstet Invest. 1995;39(1):15-8.

Garite TJ, Gocke SE. Diagnosis of preterm rupture of membranes: is testing for alpha-fetoprotein better than ferning or nitrazine? Am J Perinatol. 1990 Jul;7(3):276-8.

Kishida T, Yamada H, Negishi H, Sagawa T, Makinoda S, Fujimoto S. Diagnosis of preterm premature rupture of the membranes using a newly developed AFP monoclonal antibody test kit. Eur J Obstet Gynecol Reprod Biol. 1995 Jan;58(1):67-72.

Rochelson BL, Rodke G, White R, Bracero L, Baker DA. A rapid colorimetric AFP monoclonal antibody test for the diagnosis of preterm rupture of the membranes. Obstet Gynecol. 1987 Feb;69(2):163-6.

Responsible Party:	Clinical studies manager, Common Sense Ltd.
ClinicalTrials.gov Identifier:	NCT00604838 History of Changes
Other Study ID Numbers:	AlSense-Pivot101
Study First Received:	January 17, 2008
Last Updated:	January 29, 2008
Health Authority:	United States: Food and Drug Administration Israel: Ministry of Health

Keywords provided by Western Galilee Hospital-Nahariya:

amniotic fluid leakage
urinary incontinence
pregnancy
home test
vaginal wetness

ClinicalTrials.gov processed this record on May 19, 2013