Diagnosis and Prediction of Pre-Eclampsia by Using Congo Red Dot Test in Bangladesh and Mexico

Gynuity Health Projects

Status: Completed

Conditions: Preeclampsia

Treatments: Device: Congo Red Dot Test

Study type: Observational

Funder types: Other

Identifiers

NCT02381210

4004-A

Details and patient eligibility

About

A cross sectional study design will evaluate the diagnostic value of the CRD test to the pregnant women attending the Dhaka Medical College Hospital and Hospital Materno-Infantil Inguarán, tertiary level facilities in Bangladesh and Mexico City.

Full description

A cross sectional study design will evaluate the diagnostic value of the Congo Red Dot test to the pregnant women attending the Dhaka Medical College Hospital and Hospital Materno-Infantil Inguarán, tertiary level facilities in Bangladesh and Mexico City. Women attending the hospital with clinically confirmed cases of preeclampsia and clinically healthy women who deliver at term will be eligible for the study. Investigators will enroll about 200 women at each facility. Investigators will target the following women for enrollment: women with clinical diagnosis of preeclampsia (severe, mild or superimposed) (n=100); and clinically healthy women who deliver at term (n=100). The purpose of the research is to determine the clinical utility of congophilia (affinity for the dye Congo Red) in the diagnosis and prediction of preeclampsia. Investigators will determine the diagnostic value of this test by testing the urine sample provided to determine the presence or absence of proteinuria or congophilia.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant
• Willing to provide a urine sample
• Eligible to consent to research according to local laws and regulations
• Present with a clinical diagnosis of preeclampsia (severe, mild or superimposed) OR clinically healthy and delivering at term

Exclusion criteria

-None

Trial design

400 participants in 2 patient groups

CLINICALLY CONFIRMED PREECLAMPSIA

Description:

Pregnant women with clinical diagnosis of preeclampsia (severe, mild or superimposed) will provide a urine sample to determine the presence or absence of proteinuria using the Congo Red Dot test.

Treatment:

Device: Congo Red Dot Test

CLINICALLY HEALTHY

Description:

Pregnant women admitted to the hospital for delivery of a healthy normal baby at term (induction of labor or an elective Caesarean Section) will provide a urine sample to determine the presence or absence of proteinuria using the Congo Red Dot test.

Treatment:

Device: Congo Red Dot Test