Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine

Study Overview
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Brief Summary
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The purpose of this study is to compare the reliability and validity of a new device with standard methods for diagnosing between amniotic fluid leakage due to premature rupture of the membranes (PROM) and urine.

Detailed Description
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Pregnant women sensing wetness and arriving to the delivery room with suspect PROM will use a self-testing device to test whether the wetness is caused by amniotic fluid leakage or urinary incontinence. Clinical evaluation will be performed to all pregnant women using standard clinical tests. The results of the standard clinical tests will be compared to the women's reading of the self-testing device results. Sensitivity and specificity of the device evaluation will be calculated.

Official Title
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Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine

Conditions
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Amniotic Fluid Leakage

Intervention / Treatment
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* Device: BirthSign


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women age 18 years and older attending delivery room. Stage of gestation: pregnancy between 16 and 42 weeks of gestation. Able and willing to read and sign an informed consent document. Exclusion Criteria: Subjects will be excluded from the study if any of the following will be present: Prior use of any amniotic fluid detection test. Use of vaginal douching apparatus (such as a vaginal bulb syringe) or vaginal products such as creams or gels within the past 24 hours. Vaginal bleeding or spotting or excess abnormal vaginal discharge within the past 24 hours. Sexual intercourse within the past 24 hours. Confirmed diagnosis of any vaginal infection within the past 7 days. Use of vaginal products or antibiotic treatments that reduce bacterial population or use of medications such as tamoxifen that reduce estrogen levels or antihistamines that dry mucous membranes within the past 7 days.. Patients unable or unwilling to participate. Patients in active labor (or with regular contractions).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A device for identifying between amniotic fluid and urine<br> | Device: BirthSign<br>* When leakage from the vagina occurs, the woman will wet the indicator lines of the device with the body fluids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence / absence of stains comparing to a known color index printed on the product | Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the woman. | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence / absence of stains comparing to a known color index printed on the product | Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the clinician and a measurement of patient comfort while using the device, reading the results and clarity of instructions. | 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amniotic fluid leakage, Urinary incontinence