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

NCT02381210 | Completed DMC

• 1 other identifier: 4004-A
• Study Type: observational
• Target: 400
• Locations: 2 countries
• Sites: 2

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.

Conditions

Preeclampsia

Keywords

Congo Red Dot Test

Outcome Measures

Primary Outcomes (1)

• Prevalence of urine congophilia using Congo Red Dot test

  within 1 month of urine sample collection

Study Arms (2)

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

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

Interventions

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.

CLINICALLY CONFIRMED PREECLAMPSIA; CLINICALLY HEALTHY

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Gynuity Health Projects: lead
• Nationwide Children's Hospital: collaborator

Study Sites (2)

Dhaka Medical College

Dhaka, Bangladesh

Location

Hospital Materno-Infantil Inguarán

Mexico City, Mexico

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine samples collected

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Irina Buhimschi, Dr

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

• Beverly Winikoff, Dr

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 6, 2015
• Study Start: July 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 30, 2018
• Last Updated: February 8, 2019

Record last verified: 2018-11

Locations

BA (1); ME (1)