Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
330 participants
INTERVENTIONAL
2006-05-31
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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I
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Western Galilee Hospital-Nahariya
OTHER_GOV
Responsible Party
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Common Sense Ltd.
Principal Investigators
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Jacob Bornstein, MD
Role: PRINCIPAL_INVESTIGATOR
Western Galilee Hospital-Nahariya
Yoram Sorokin, MD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University / Hutzel Women's Hospital
Locations
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Wayne State University / Hutzel Women's Hospital
Detroit, Michigan, United States
Western Galilee Hospital-Nahariya
Nahariya, , Israel
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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AlSense-Pivot101
Identifier Type: -
Identifier Source: org_study_id