Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Case-control Study

August 20, 2019 updated by: Gynuity Health Projects
A case-control study will evaluate the clinical utility of the Congo Red test GV-005 in following women with a clinical diagnosis of preeclampsia and clinically healthy women in the postpartum period

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A case-control study (n=150) will evaluate the clinical utility of the Congo Red test GV-005 in following women with a clinical diagnosis of preeclampsia and clinically healthy women in the postpartum period. Women with preeclampsia (n=100) (cases) and clinically healthy women (n=50)(controls) who are hospitalized postpartum will be recruited for the trial. All women will be asked to provide a urine sample. Samples will be collected daily during a woman's hospitalization. The Congo Red test GV-005 and a standard urine dipstick proteinuria test will be performed by a lab technician within 72 hours of sample collection. The purpose of this research is to evaluate progression of urine congophilia postpartum by following patients diagnosed with preeclampsia and clinically healthy women.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women attending Dhaka Medical College (Dhaka) with clinically confirmed cases of preeclampsia and clinically healthy women who deliver at term will be eligible for the study.

Description

Inclusion Criteria:

  • Postpartum
  • Clinical diagnosis of preeclampsia (severe, mild or superimposed) including eclampsia (n=100) OR Clinically healthy (n=50)
  • Eligible to consent for research
  • Agree to comply with study procedures
  • Able to give informed consent

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CLINICALLY CONFIRMED PREECLAMPSIA
Women clinically diagnosed with preeclampsia (severe, mild or superimposed) during pregnancy will provide a urine sample in the postpartum period to determine the presence or absence of proteinuria using the Congo Red test GV-005.
Device: Congo Red test GV-005
Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine.
CLINICALLY HEALTHY
Women with a delivery of a healthy normal baby at term (induction of labor or an elective Caesarean Section) will provide a urine sample in the postpartum period to determine the presence or absence of proteinuria using the Congo Red test GV-005.
Device: Congo Red test GV-005
Congo Red test GV-005 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
Measure Description
Time Frame
Prevalence of Urine Congophilia Using Congo Red Test GV-005
Time Frame: within 72 hours of urine sample collection
Prevalence of urine congophilia using Congo Red test GV-005
within 72 hours of urine sample collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynuity Health Projects

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

March 30, 2019

Study Completion (Actual)

May 30, 2019

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 18, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

September 20, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4005A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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