Status:
UNKNOWN
AL-SENSE 1-Step - Determination of Product Specificity
Lead Sponsor:
Common Sense
Conditions:
PREMATURE RUPTURE OF MEMBRANES
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
Clinical diagnosis of amniotic fluid leak will be determined, according the hospital standard procedure, using pooling test and/or sterile speculum examination and /or pH test, and AmniSure, N-Dia, In...
Detailed Description
Pregnant women arriving at the hospital and reporting unidentified wetness (undetermined whether they sense amniotic fluid leakage or urinary incontinence) will receive a single AL-SENSE 1-Step to use...
Eligibility Criteria
Inclusion
- AgE 18 years OR GREATER.
- Subject who will sign the informed consent form.
- Subject who arrive at the obstetric department reporting a feeling of vaginal wetness feeling (undetermined whether she sense amniotic fluid leakage or urinary incontinence).
Exclusion
- Subjects that have had sexual relations within the last 12 hours.
- Subject is unable or unwilling to cooperate with study procedures.
- Subject is currently participating in another clinical study
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01804348
Start Date
April 1 2013
End Date
August 1 2013
Last Update
March 5 2013
Active Locations (1)
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1
Western Galilee Hospital
Nahariya, Israel