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

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381210
• Other study ID #: 4004-A
• Status: Completed
• Start date: July 2016
• Est. completion date: December 30, 2018

Study information

• Verified date: November 2018
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 30, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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:

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

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.

Locations

Country	Name	City	State
Bangladesh	Dhaka Medical College	Dhaka
Mexico	Hospital Materno-Infantil Inguarán	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	Nationwide Children's Hospital

Countries where clinical trial is conducted

Bangladesh,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of urine congophilia using Congo Red Dot test		within 1 month of urine sample collection