Trial Outcomes & Findings for Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Case-control Study (NCT NCT02610972)

Results Overview

Prevalence of urine congophilia using Congo Red test GV-005

Recruitment status

COMPLETED

Target enrollment

150 participants

Primary outcome timeframe

within 72 hours of urine sample collection

Results posted on

2019-09-20

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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. 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 Study STARTED	100	50
Overall Study COMPLETED	100	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CLINICALLY CONFIRMED PREECLAMPSIA n=100 Participants 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.	CLINICALLY HEALTHY n=50 Participants 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 n=150 Participants Total of all reporting groups
Age, Continuous	24.86 years STANDARD_DEVIATION 5.34 • n=100 Participants	24.82 years STANDARD_DEVIATION 5.08 • n=50 Participants	24.85 years STANDARD_DEVIATION 5.2 • n=150 Participants
Sex: Female, Male Female	100 Participants n=100 Participants	50 Participants n=50 Participants	150 Participants n=150 Participants
Sex: Female, Male Male	0 Participants n=100 Participants	0 Participants n=50 Participants	0 Participants n=150 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Bangladesh	100 participants n=100 Participants	50 participants n=50 Participants	150 participants n=150 Participants

PRIMARY outcome

Timeframe: within 72 hours of urine sample collection

Prevalence of urine congophilia using Congo Red test GV-005

Outcome measures

Outcome measures
Measure	CLINICALLY CONFIRMED PREECLAMPSIA n=100 Participants 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.	CLINICALLY HEALTHY n=50 Participants 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.
Prevalence of Urine Congophilia Using Congo Red Test GV-005	87 Participants	18 Participants

Adverse Events

CLINICALLY CONFIRMED PREECLAMPSIA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CLINICALLY HEALTHY

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hillary Bracken

Gynuity Health Projects

Phone: 2124481230

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place