NCT02610972

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Preeclampsia

Interventions

Type	Name	Description
DEVICE	Congo Red test GV-005	Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine.

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-03-30
• Completion: 2019-05-30
• First posted: 2015-11-20
• Last updated: 2019-09-20
• Results posted: 2019-09-20

Locations

2 sites across 2 countries: Bangladesh, Mexico