A Phase 2/3 interventional study of BirthSign in Amniotic Fluid Leakage, sponsored by Hadassah Medical Organization. Status unknown at 1 site in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-25.
Sponsored by Hadassah Medical Organization · Phase 2/3, Interventional, and Diagnostic
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.
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.
1,375 studies on the registry are indexed under Urinary Incontinence; 224 are open to participants now.
This study's planned enrollment of 100 is above the median of 66 across 1,021 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Hadassah Medical Organization is the lead sponsor of 674 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Subjects will be excluded from the study if any of the following will be present:
Device: BirthSign
When leakage from the vagina occurs, the woman will wet the indicator lines of the device with the body fluids.
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.
Time frame: 12 hours
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.
Time frame: 12 hours
The record gives a start of Jan 2012 and a primary completion of Jan 2013. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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