Amniotic Fluid Leakage
Conditions
Keywords
amniotic fluid leakage, urinary incontinence, pregnancy, home test, vaginal wetness
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.
Interventions
DEVICEAL-SENSE Diagnostic Absorbent Panty liner
worn for 12 hours
Sponsors
Western Galilee Hospital-Nahariya
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Israel, United States
Outcome results
None listed