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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Preeclampsia

Intervention / Treatment
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* Device: Congo Red Dot Test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CLINICALLY CONFIRMED PREECLAMPSIA<br>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. | Device: Congo Red Dot Test<br>* The Congo Red Dot test is a simple test has been developed to detect unfolded or misfolded proteins in urine.<br>|
| CLINICALLY HEALTHY<br>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. | Device: Congo Red Dot Test<br>* The Congo Red Dot test is a simple test has been developed to detect unfolded or misfolded proteins in urine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of urine congophilia using Congo Red Dot test |  | within 1 month of urine sample collection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congo Red Dot Test