Pivotal Study of the Al-Sense Study Protocol

Phase 1

Completed

• Conditions: Amniotic Fluid Leakage
• Interventions: Device: AL-SENSE Diagnostic Absorbent Panty liner

• Registration Number: NCT00604838
• Lead Sponsor: Western Galilee Hospital-Nahariya

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2008-01
• Study First Submitted: 2008-01-17
• Study First Submitted QC: 2008-01-29
• Last Update Submitted: 2008-01-29
• Study First Posted: 2008-01-30
• Last Update Posted: 2008-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
I	AL-SENSE Diagnostic Absorbent Panty liner	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Wayne State University / Hutzel Women's Hospital; 🇺🇸 Detroit, Michigan, United States

Western Galilee Hospital-Nahariya; 🇮🇱 Nahariya, Israel