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

Diagnosis and Prediction of Preeclampsia: A Case Control Study of the Clinical Utility of Congo Red Dot Test in Bangladesh and Mexico

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02381210

Enrollment

400

Registered

2015-03-06

Start date

2016-07-31

Completion date

2018-12-30

Last updated

2019-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Keywords

Congo Red Dot Test

Brief summary

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.

Detailed 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.

Interventions

DEVICECongo Red Dot Test

The Congo Red Dot test is a simple test has been developed to detect unfolded or misfolded proteins in urine.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Prevalence of urine congophilia using Congo Red Dot test	within 1 month of urine sample collection

Countries

Bangladesh, Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026