Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine
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|ClinicalTrials.gov Identifier: NCT01517633|
Recruitment Status : Unknown
Verified January 2012 by Hadassah Medical Organization.
Recruitment status was: Active, not recruiting
First Posted : January 25, 2012
Last Update Posted : January 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Amniotic Fluid Leakage||Device: BirthSign||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||January 2013|
|Experimental: A device for identifying between amniotic fluid and urine||
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 [ Time Frame: 12 hours ]Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the woman.
- Presence / absence of stains comparing to a known color index printed on the product [ Time Frame: 12 hours ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517633
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|