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

NCT02610972 | Completed Results

• 1 other identifier: 4005A
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Preeclampsia

Keywords

Congo Red test GV-005

Outcome Measures

Primary Outcomes (1)

• Prevalence of Urine Congophilia Using Congo Red Test GV-005

  Prevalence of urine congophilia using Congo Red test GV-005

  within 72 hours of urine sample collection

Study Arms (2)

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

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

Interventions

Congo Red test GV-005 DEVICE

Congo Red test GV-005 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 (Dhaka) with clinically confirmed cases of preeclampsia and clinically healthy women who deliver at term will be eligible for the study.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Gynuity Health Projects: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: 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

Results Point of Contact

• Title: Hillary Bracken
• Organization: Gynuity Health Projects

hbracken@gynuity.org

2124481230

Study Officials

• Beverly Winikoff, Dr

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 20, 2015
• Study Start: December 1, 2018
• Primary Completion: March 30, 2019
• Study Completion: May 30, 2019
• Last Updated: September 20, 2019
• Results First Posted: September 20, 2019

Record last verified: 2019-08

Locations

ME (1); BA (1)