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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-12-30

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.

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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.

Conditions

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Preeclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CLINICALLY CONFIRMED PREECLAMPSIA

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.

Congo Red Dot Test

Intervention Type DEVICE

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

CLINICALLY HEALTHY

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.

Congo Red Dot Test

Intervention Type DEVICE

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

Interventions

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Congo Red Dot Test

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

Intervention Type DEVICE

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