PreeclampsiaNCT02610972
Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Case-control Study
An observational study of Preeclampsia, run by Gynuity Health Projects at 2 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Congo Red test GV-005
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2018to 30 May 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
Read the 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.
- Conditions
- Preeclampsia
- Being tested
- Congo Red test GV-005
- Keywords
- Congo Red test GV-005
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Congo Red test GV-005Device
Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 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. Receives: Device: Congo Red test GV-005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Urine Congophilia Using Congo Red Test GV-005
Prevalence of urine congophilia using Congo Red test GV-005
Measured: within 72 hours of urine sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start1 Dec 2018
- Primary completion30 Mar 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, Dr, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610972
- Sponsor's protocol ID
- 4005A
- Status last verified
- Aug 2019
- First submitted
- 18 Nov 2015
- Last updated
- 20 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Case-control Study
- ClinicalTrials.gov ID
- NCT02610972
- Acronym / sponsor ID
- 4005A
- Conditions
- Preeclampsia
- Keywords
- Congo Red test GV-005
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Posted 20 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLINICALLY CONFIRMED PREECLAMPSIA | – | Device: Congo Red test GV-005Women 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 | – | Device: Congo Red test GV-005Women 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Congo Red test GV-005Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine. | Device | CLINICALLY CONFIRMED PREECLAMPSIA, CLINICALLY HEALTHY |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Preeclampsia
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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverly Winikoff, Dr principal investigator
Gynuity Health Projects
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Gynuity Health Projects at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Urine Congophilia Using Congo Red Test GV-005 (time frame: within 72 hours of urine sample collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.