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NCT Number: NCT02610972

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

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

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

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 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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2015
Registry last updated
Sep 20, 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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