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

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610972
• Other study ID #: 4005A
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: August 2019
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

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.

Locations

Country	Name	City	State
Bangladesh	Dhaka Medical College	Dhaka
Mexico	Hospital Materno-Infantil Inguarán	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	International Centre for Diarrhoeal Disease Research, Bangladesh

Countries where clinical trial is conducted

Bangladesh,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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