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

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.

Study Overview

• Status: Completed
• Conditions: Preeclampsia
• Intervention / Treatment: Device: Congo Red Dot Test

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • Dhaka Medical College
• Mexico
  • Mexico City, Mexico
    • Hospital Materno-Infantil Inguarán

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women attending Dhaka Medical College Hospital and Hospital Materno-Infantil Inguarán with clinically confirmed cases of preeclampsia and clinically healthy women who deliver at term will be eligible for the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Congo Red Dot Test; 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.	Device: Congo Red Dot Test; The Congo Red Dot test is a simple test has been developed to detect unfolded or misfolded proteins in urine.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): December 30, 2018

Study Registration Dates

• First Submitted: February 25, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (ESTIMATE): March 6, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Congo Red Dot Test
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: 4004-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED