Clinical trial NCT00604838: Pivotal Study of the Al-Sense Study Protocol
Official title: Pivotal Study of the Al-ASense Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Amniotic Fluid Leakage
Keywords: amniotic fluid leakage
urinary incontinence
pregnancy
home test
vaginal wetness
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2008-01-30
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: presence or absence of a blue-green stain on a yellow background as yielded by the AL-SENSE and observed by the patient.
timeFrame: up to 12 hours
Secondary outcomes:
measure: 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.
timeFrame: up to 12 hours
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University / Hutzel Women's Hospital
state: Michigan
city: Nahariya
country: Israel
facility: Western Galilee Hospital-Nahariya
Study officials:
affiliation: Western Galilee Hospital-Nahariya
name: Jacob Bornstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University / Hutzel Women's Hospital
name: Yoram Sorokin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1159/000292368.
citation: 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.
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. doi: 10.1016/0028-2243(94)01973-b.
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.