NCT00604838

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2006

Shorter than P25 for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
Last Updated

January 30, 2008

Status Verified

January 1, 2008

Enrollment Period

6 months

First QC Date

January 17, 2008

Last Update Submit

January 29, 2008

Conditions

Amniotic Fluid Leakage

Keywords

amniotic fluid leakageurinary incontinencepregnancyhome testvaginal wetness

Outcome Measures

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.

    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.

    up to 12 hours

Study Arms (1)

I

EXPERIMENTAL
Device: AL-SENSE Diagnostic Absorbent Panty liner

Interventions

AL-SENSE Diagnostic Absorbent Panty linerDEVICE

worn for 12 hours

Also known as: AL-SENSE Amniotic Leak Test Kit
I

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wayne State University / Hutzel Women's Hospital

Detroit, Michigan, 48201, United States

Location

Western Galilee Hospital-Nahariya

Nahariya, 22100, Israel

Location

Related Publications (4)

  • 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.

    PMID: 7534254BACKGROUND

  • 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.

    PMID: 1695510BACKGROUND

  • 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.

    PMID: 7538939BACKGROUND

  • 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.

    PMID: 2433650BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jacob Bornstein, MD

    Western Galilee Hospital-Nahariya

    PRINCIPAL INVESTIGATOR

  • Yoram Sorokin, MD

    Wayne State University / Hutzel Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 17, 2008

First Posted

January 30, 2008

Study Start

May 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

January 30, 2008

Record last verified: 2008-01

Locations

US(1)IL(1)