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Completed

NCT Number: NCT00604838

Pivotal Study of the Al-Sense 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.

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Key information

Conditions

Amniotic Fluid Leakage Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Western Galilee Hospital-Nahariya, Nahariya, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AL-SENSE Diagnostic Absorbent Panty liner

Device

worn for 12 hours

Other names: AL-SENSE Amniotic Leak Test Kit

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Official study title

Pivotal Study of the Al-ASense Study Protocol

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jan 30, 2008
Registry last updated
Jan 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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