Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Case-control Study

Study Overview
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Brief Summary
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A case-control study will evaluate the clinical utility of the Congo Red test GV-005 in following women with a clinical diagnosis of preeclampsia and clinically healthy women in the postpartum period

Detailed Description
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A case-control study (n=150) will evaluate the clinical utility of the Congo Red test GV-005 in following women with a clinical diagnosis of preeclampsia and clinically healthy women in the postpartum period. Women with preeclampsia (n=100) (cases) and clinically healthy women (n=50)(controls) who are hospitalized postpartum will be recruited for the trial. All women will be asked to provide a urine sample. Samples will be collected daily during a woman's hospitalization. The Congo Red test GV-005 and a standard urine dipstick proteinuria test will be performed by a lab technician within 72 hours of sample collection. The purpose of this research is to evaluate progression of urine congophilia postpartum by following patients diagnosed with preeclampsia and clinically healthy women.

Official Title
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Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Case-control Study

Conditions
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Preeclampsia

Intervention / Treatment
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* Device: Congo Red test GV-005


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postpartum Clinical diagnosis of preeclampsia (severe, mild or superimposed) including eclampsia (n=100) OR Clinically healthy (n=50) Eligible to consent for research Agree to comply with study procedures Able to give informed consent Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CLINICALLY CONFIRMED PREECLAMPSIA<br>Women clinically diagnosed with preeclampsia (severe, mild or superimposed) during pregnancy will provide a urine sample in the postpartum period to determine the presence or absence of proteinuria using the Congo Red test GV-005. | Device: Congo Red test GV-005<br>* Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine.<br>|
| CLINICALLY HEALTHY<br>Women with a delivery of a healthy normal baby at term (induction of labor or an elective Caesarean Section) will provide a urine sample in the postpartum period to determine the presence or absence of proteinuria using the Congo Red test GV-005. | Device: Congo Red test GV-005<br>* Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Urine Congophilia Using Congo Red Test GV-005 | Prevalence of urine congophilia using Congo Red test GV-005 | within 72 hours of urine sample collection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congo Red test GV-005