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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

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Prospective
Condition Preeclampsia
Intervention Device: Congo Red test GV-005
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CLINICALLY CONFIRMED PREECLAMPSIA CLINICALLY HEALTHY
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 100 50
Completed 100 50
Not Completed 0 0
Arm/Group Title CLINICALLY CONFIRMED PREECLAMPSIA CLINICALLY HEALTHY Total
Hide Arm/Group Description

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 100 50 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 50 participants 150 participants
24.86  (5.34) 24.82  (5.08) 24.85  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 50 participants 150 participants
Female
100
 100.0%
50
 100.0%
150
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Bangladesh Number Analyzed 100 participants 50 participants 150 participants
100 50 150
1.Primary Outcome
Title Prevalence of Urine Congophilia Using Congo Red Test GV-005
Hide Description Prevalence of urine congophilia using Congo Red test GV-005
Time Frame within 72 hours of urine sample collection
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CLINICALLY CONFIRMED PREECLAMPSIA CLINICALLY HEALTHY
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 100 50
Measure Type: Count of Participants
Unit of Measure: Participants
87
  87.0%
18
  36.0%
Time Frame 72 hours from time of enrollment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CLINICALLY CONFIRMED PREECLAMPSIA CLINICALLY HEALTHY
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
CLINICALLY CONFIRMED PREECLAMPSIA CLINICALLY HEALTHY
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/50 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
CLINICALLY CONFIRMED PREECLAMPSIA CLINICALLY HEALTHY
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CLINICALLY CONFIRMED PREECLAMPSIA CLINICALLY HEALTHY
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/50 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hillary Bracken
Organization: Gynuity Health Projects
Phone: 2124481230
EMail: hbracken@gynuity.org
Layout table for additonal information
Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02610972     History of Changes
Other Study ID Numbers: 4005A
First Submitted: November 18, 2015
First Posted: November 20, 2015
Results First Submitted: August 20, 2019
Results First Posted: September 20, 2019
Last Update Posted: September 20, 2019