Pivotal Study of the Al-Sense Study Protocol

Pivotal Study of the Al-ASense Study Protocol

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.

Study Overview

• Status: Completed
• Conditions: Amniotic Fluid Leakage
• Intervention / Treatment: Device: AL-SENSE Diagnostic Absorbent Panty liner; Device: AL-SENSE Diagnostic Absorbent Panty liner

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Nahariya, Israel, 22100
    • Western Galilee Hospital-Nahariya
• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University / Hutzel Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I	Device: AL-SENSE Diagnostic Absorbent Panty liner; worn for 12 hours; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
presence or absence of a blue-green stain on a yellow background as yielded by the AL-SENSE and observed by the patient.	up to 12 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	up to 12 hours

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General 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. doi: 10.1159/000292368.
• 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. doi: 10.1055/s-2007-999500.
• 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. doi: 10.1016/0028-2243(94)01973-b.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: January 17, 2008
• First Submitted That Met QC Criteria: January 29, 2008
• First Posted (Estimate): January 30, 2008

Study Record Updates

• Last Update Posted (Estimate): January 30, 2008
• Last Update Submitted That Met QC Criteria: January 29, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: pregnancy; urinary incontinence; amniotic fluid leakage; home test; vaginal wetness
• Other Study ID Numbers: AlSense-Pivot101