Pivotal Study of the Al-Sense Study Protocol

Amniotic Fluid Leakage Clinical Trial

Official title:

Pivotal Study of the Al-ASense Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604838
• Other study ID #: AlSense-Pivot101
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 17, 2008
• Last updated: January 29, 2008
• Start date: May 2006
• Est. completion date: November 2006

Study information

• Verified date: January 2008
• Source: Western Galilee Hospital-Nahariya
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Amniotic Fluid Leakage

Intervention

Device:
• AL-SENSE Diagnostic Absorbent Panty liner
worn for 12 hours
• 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

Locations

Country	Name	City	State
Israel	Western Galilee Hospital-Nahariya	Nahariya
United States	Wayne State University / Hutzel Women's Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Countries where clinical trial is conducted

United States,  Israel, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No