Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Urine Congophilia Using Congo Red Test GV-005 | Prevalence of urine congophilia using Congo Red test GV-005 | within 72 hours of urine sample collection |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, Dr | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dhaka Medical College | Dhaka | Bangladesh | ||||
| Hospital Materno-Infantil Inguarán |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prevalence of Urine Congophilia Using Congo Red Test GV-005 | Prevalence of urine congophilia using Congo Red test GV-005 | Posted | Count of Participants | Participants | within 72 hours of urine sample collection |
|
72 hours from time of enrollment
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hillary Bracken | Gynuity Health Projects | 2124481230 | hbracken@gynuity.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2018 | Aug 20, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
urine samples collected
| Mexico City |
| Mexico |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | 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. | 0 | 50 | 0 | 50 | 0 | 50 |
Not provided
Not provided