Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine
NCT01517633 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2012-01-25
Summary
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.
Conditions
- Amniotic Fluid Leakage
Interventions
- DEVICE
-
BirthSign
When leakage from the vagina occurs, the woman will wet the indicator lines of the device with the body fluids.
Sponsors & Collaborators
-
Hadassah Medical Organization
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2013-01-31
Countries
- Israel
Study Locations
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