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

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ClinicalTrials.gov Identifier: NCT02610972
Recruitment Status : Completed
First Posted : November 20, 2015
Results First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Gynuity Health Projects

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

Condition or disease Intervention/treatment
Preeclampsia Device: Congo Red test GV-005

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.

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Case-control Study
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
urine samples collected


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610972


Locations
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Bangladesh
Dhaka Medical College
Dhaka, Bangladesh
Mexico
Hospital Materno-Infantil Inguarán
Mexico City, Mexico
Sponsors and Collaborators
Gynuity Health Projects
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
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Principal Investigator: Beverly Winikoff, Dr Gynuity Health Projects
  Study Documents (Full-Text)

Documents provided by Gynuity Health Projects:

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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02610972     History of Changes
Other Study ID Numbers: 4005A
First Posted: November 20, 2015    Key Record Dates
Results First Posted: September 20, 2019
Last Update Posted: September 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Gynuity Health Projects:
Congo Red test GV-005
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications