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Completed

NCT Number: NCT02381210

Diagnosis and Prediction of Pre-Eclampsia by Using 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.

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Key information

Age range

18 year–64 year

Sex eligibility

Female

Study type

Observational

Primary location

Dhaka Medical College, Dhaka, Bangladesh

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Congo Red Dot Test

Device

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

Primary outcomes

  1. Prevalence of urine congophilia using Congo Red Dot test

    Time frame: within 1 month of urine sample collection

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Nationwide Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 6, 2015
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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