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

Gynuity Health Projects

Status: Completed

Conditions: Preeclampsia

Treatments: Device: Congo Red test GV-005

Study type: Observational

Funder types: Other

Identifiers

NCT02610972

4005A

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

CLINICALLY CONFIRMED PREECLAMPSIA

Description:

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.

Treatment:

Device: Congo Red test GV-005

CLINICALLY HEALTHY

Description:

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.

Treatment:

Device: Congo Red test GV-005