Preeclampsia
Conditions
Keywords
Congo Red test GV-005
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
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.
Interventions
DEVICECongo 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.
Sponsors
International Centre for Diarrhoeal Disease Research, Bangladesh
Gynuity Health Projects
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Urine Congophilia Using Congo Red Test GV-005 | within 72 hours of urine sample collection | Prevalence of urine congophilia using Congo Red test GV-005 |
Countries
Bangladesh, Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 100 |
| 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. | 50 |
| Total | 150 |
Baseline characteristics
| Characteristic | CLINICALLY HEALTHY | Total | CLINICALLY CONFIRMED PREECLAMPSIA |
|---|---|---|---|
| Age, Continuous | 24.82 years STANDARD_DEVIATION 5.08 | 24.85 years STANDARD_DEVIATION 5.2 | 24.86 years STANDARD_DEVIATION 5.34 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Bangladesh | 50 participants | 150 participants | 100 participants |
| Sex: Female, Male Female | 50 Participants | 150 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 50 |
| other Total, other adverse events | 0 / 100 | 0 / 50 |
| serious Total, serious adverse events | 0 / 100 | 0 / 50 |
Outcome results
Primary
Prevalence of Urine Congophilia Using Congo Red Test GV-005
Prevalence of urine congophilia using Congo Red test GV-005
Time frame: within 72 hours of urine sample collection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CLINICALLY CONFIRMED PREECLAMPSIA | Prevalence of Urine Congophilia Using Congo Red Test GV-005 | 87 Participants |
| CLINICALLY HEALTHY | Prevalence of Urine Congophilia Using Congo Red Test GV-005 | 18 Participants |