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

Completed

• Conditions: Preeclampsia
• Interventions: Device: Congo Red Dot Test

• Registration Number: NCT02381210
• Lead Sponsor: Gynuity Health Projects

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.

Study Timeline

• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-06
• Study Start: 2016-07
• Status Verified: 2018-11
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-30
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CLINICALLY HEALTHY	Congo Red Dot Test	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.
CLINICALLY CONFIRMED PREECLAMPSIA	Congo Red Dot Test	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.

Primary Outcome Measures

Name	Time	Method
Prevalence of urine congophilia using Congo Red Dot test	within 1 month of urine sample collection

Trial Locations

Locations (2)

Dhaka Medical College; 🇧🇩 Dhaka, Bangladesh

Hospital Materno-Infantil Inguarán; 🇲🇽 Mexico City, Mexico