ProteinuriaNCT03510286
Validation of a PrCr Dipstick Diagnostic Test in Ghana
An observational study of Proteinuria and Preeclampsia, run by PATH at 1 site in Ghana.
Trial summary
This evaluation will aim to generate a body of evidence that will determine performance characteristics of the current PrCr dipstick test and the feasibility of its use in target ANC settings. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Proteinuria, Preeclampsia
- What is being tested?
- Test-it™ PrCr Urinalysis Strips
- How many people
- 1,483 participants
- Where
- 1 siteGhana
- Study dates
- 30 Sep 2018to 30 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women attending ANC clinics in Techiman Holy Family Hospital and Kintampo North and South districts (all hospitals and clinics inclusive where ANC services are provided) are the primary participant group- primarily women of reproductive age. Pregnant women are a potentially vulnerable population whose participation in this research is necessary given the target use case for this diagnostic tool: providing reliable and accurate point of care screening of proteinuria in ANC settings. The legal age of consent in Ghana is 18 years and women under the age of 18 will not be recruited for this study.
Who may be able to join
- Pregnant woman 18 years of age or older (self-report)
- Attending a study site facility for ANC
- ANC visit is within the final 12 weeks of pregnancy (within 12 weeks or less before expected due date)
- Willing to provide written informed consent for study participation
Who cannot join
- ANC visit is not within the final 12 weeks of pregnancy
- Unwilling to provide written informed consent for study participation
- Pregnant woman less than 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Protein Creatinine (PrCr) Dipstick Diagnostic Test for Proteinuria Screening in Antenatal Care Clinics in Ghana
This evaluation will aim to generate a body of evidence that will determine performance characteristics of the current PrCr dipstick test and the feasibility of its use in target ANC settings. Data will be used to inform further product development and/or support development of an introduction framework, including the process and associated resources needed for incorporation of the PrCr test into future larger-scale demonstration studies as well as to support early product launch.
The objectives of the evaluation are as follows:
Read more
Primary objective: Assess the accuracy of the PrCr dipstick test for detection of proteinuria in representative antenatal care settings in Ghana.
Exploratory objectives:
- Understand the feasibility of integrating the use of the PrCr test into ANC services in Ghana.
- Explore the potential for improved ANC management of PE/E using the PrCr test in intended ANC settings versus the current standard of care used for proteinuria screening, protein-only determination via a low -cost urine dipstick test.
Read the detailed description
This cross-sectional diagnostic accuracy evaluation will employ mixed methods to assess the performance of the PrCr dipstick test and to explore the operational feasibility of using this test as an alternative to the current protein-only test. These methods include:
Assess the accuracy of the PrCr test for detection of proteinuria in a representative ANC setting in Ghana.
- Detection of proteinuria using the PrCr dipstick test compared to the current standard of care and laboratory reference assay used for confirming proteinuria. Patient samples will be tested with multiple assays. The PrCr test and a protein-only dipstick (The Mission® Urinalysis Reagent Strips (Urine), will be used at the point of care. Patient samples will be transferred to KHRC laboratory using cold boxes (conditioned at 2oC - 8oC) and will be tested using a laboratory reference assay.
Understand the feasibility of integrating the use of the PrCr test into ANC services.
- Pre- and post-evaluation of ANC staff training on use of the PrCr test
- Interviews with ANC staff
- Consultations with key district and national stakeholders.
Explore the potential for improved ANC management of PE/E using the PrCr test in the intended ANC setting.
- Analysis of pregnancy outcomes (live or stillbirth) and review of referral records. Actual outcomes along with referral practices and linkage to care based on the current diagnostics will be compared to any potential changes in referral practices and linkage to care based on prospective PrCr test results.
- Assessment of use of PrCr test with other clinical indicators and integration into diagnostic algorithms. Prospective PrCr test results will be integrated into an existing diagnostic algorithm to assess any potential changes in referral practices and linkage to care.
- Conditions
- Proteinuria, Preeclampsia
- Being tested
- Test-it™ PrCr Urinalysis Strips
- Keywords
- proteinuria, preeclampsia, diagnostic, dipstick, protein, urine, creatinine
- Medical subject headings
- Proteinuria, Pre-Eclampsia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test-it™ PrCr Urinalysis StripsDiagnostic test
The LifeAssay Diagnostics prototype PrCr dipstick has been designed to provide the measurement of both protein and creatinine while retaining a very low estimated cost that is comparable to the current protein-only dipsticks at $0.06-0.10 per test. In 2015, an initial laboratory-based validation study of the prototype LAD PrCr test was used on more than 500 characterized urine samples from pregnant women. This validation study demonstrated comparable accuracy for detection of severe proteinuria of the LAD PrCr test to the much more expensive commercial POC test available for PrCr determination, the Siemens Multistix® PRO 10LS. These results were compared to laboratory-based reference standard assays for proteinuria measurement.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Pregnant women attending ANC clinics in Techiman Holy Family Hospital and Kintampo North and South districts (all hospitals and clinics inclusive where ANC services are provided) are the primary participant group- primarily women of reproductive age. Pregnant women attending routine ANC will be enrolled. In addition to routine ANC, pregnant women will be tested with the Test-it™ PrCr Urinalysis Strips. Pregnant women are a potentially vulnerable population whose participation in this research is necessary given the target use case for this diagnostic tool: providing reliable and accurate point of care screening of proteinuria in ANC settings. The legal age of consent in Ghana is 18 years and women under the age of 18 will not be recruited for this study. Receives: Diagnostic Test: Test-it™ PrCr Urinalysis Strips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the PrCr dipstick test compared to a laboratory reference assay (chemistry analyzer measurement of protein and creatinine)
The results of the PrCr dipstick test will be compared to the results of a laboratory reference assay. Sensitivity and specificity analyses will be conducted at thresholds for normal and proteinuria.
Measured: September 20198-February 2019
Accuracy of the PrCr dipstick test compared to a protein only dipstick.
The results of the PrCr dipstick test will be compared to the results of the protein only test. Sensitivity and specificity analyses will be conducted at thresholds for normal and proteinuria.
Measured: September 20198-February 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start30 Sep 2018
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProteinuriaStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,483 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Kintampo Health Research Centre, Ghana, United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Samuel Newton, PhD, Principal investigator, Kintampo Health Research Centre, Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510286
- Sponsor's protocol ID
- 1133673-2
- Status last verified
- Aug 2019
- First submitted
- 17 Apr 2018
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Protein Creatinine (PrCr) Dipstick Diagnostic Test for Proteinuria Screening in Antenatal Care Clinics in Ghana
- ClinicalTrials.gov ID
- NCT03510286
- Acronym / sponsor ID
- 1133673-2
- Conditions
- Proteinuria, Preeclampsia
- Keywords
- proteinuria, preeclampsia, diagnostic, dipstick, protein, urine, creatinine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,483 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Kintampo Health Research Centre, Ghana, United States Agency for International Development (USAID)
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This evaluation will aim to generate a body of evidence that will determine performance characteristics of the current PrCr dipstick test and the feasibility of its use in target ANC settings. Data will be used to inform further product development and/or support development of an introduction framework, including the process and associated resources needed for incorporation of the PrCr test into future larger-scale demonstration studies as well as to support early product launch.
The objectives of the evaluation are as follows:
Primary objective: Assess the accuracy of the PrCr dipstick test for detection of proteinuria in representative antenatal care settings in Ghana.
Exploratory objectives:
- Understand the feasibility of integrating the use of the PrCr test into ANC services in Ghana.
- Explore the potential for improved ANC management of PE/E using the PrCr test in intended ANC settings versus the current standard of care used for proteinuria screening, protein-only determination via a low -cost urine dipstick test.
Detailed description
This cross-sectional diagnostic accuracy evaluation will employ mixed methods to assess the performance of the PrCr dipstick test and to explore the operational feasibility of using this test as an alternative to the current protein-only test. These methods include:
Assess the accuracy of the PrCr test for detection of proteinuria in a representative ANC setting in Ghana.
- Detection of proteinuria using the PrCr dipstick test compared to the current standard of care and laboratory reference assay used for confirming proteinuria. Patient samples will be tested with multiple assays. The PrCr test and a protein-only dipstick (The Mission® Urinalysis Reagent Strips (Urine), will be used at the point of care. Patient samples will be transferred to KHRC laboratory using cold boxes (conditioned at 2oC - 8oC) and will be tested using a laboratory reference assay.
Understand the feasibility of integrating the use of the PrCr test into ANC services.
- Pre- and post-evaluation of ANC staff training on use of the PrCr test
- Interviews with ANC staff
- Consultations with key district and national stakeholders.
Explore the potential for improved ANC management of PE/E using the PrCr test in the intended ANC setting.
- Analysis of pregnancy outcomes (live or stillbirth) and review of referral records. Actual outcomes along with referral practices and linkage to care based on the current diagnostics will be compared to any potential changes in referral practices and linkage to care based on prospective PrCr test results.
- Assessment of use of PrCr test with other clinical indicators and integration into diagnostic algorithms. Prospective PrCr test results will be integrated into an existing diagnostic algorithm to assess any potential changes in referral practices and linkage to care.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Diagnostic Test: Test-it™ PrCr Urinalysis StripsPregnant women attending ANC clinics in Techiman Holy Family Hospital and Kintampo North and South districts (all hospitals and clinics inclusive where ANC services are provided) are the primary participant group- primarily women of reproductive age. Pregnant women attending routine ANC will be enrolled. In addition to routine ANC, pregnant women will be tested with the Test-it™ PrCr Urinalysis Strips. Pregnant women are a potentially vulnerable population whose participation in this research is necessary given the target use case for this diagnostic tool: providing reliable and accurate point of care screening of proteinuria in ANC settings. The legal age of consent in Ghana is 18 years and women under the age of 18 will not be recruited for this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women attending ANC clinics in Techiman Holy Family Hospital and Kintampo North and South districts (all hospitals and clinics inclusive where ANC services are provided) are the primary participant group- primarily women of reproductive age. Pregnant women are a potentially vulnerable population whose participation in this research is necessary given the target use case for this diagnostic tool: providing reliable and accurate point of care screening of proteinuria in ANC settings. The legal age of consent in Ghana is 18 years and women under the age of 18 will not be recruited for this study.
Key inclusion criteria (4 listed)
- Pregnant woman 18 years of age or older (self-report)
- Attending a study site facility for ANC
- ANC visit is within the final 12 weeks of pregnancy (within 12 weeks or less before expected due date)
- Willing to provide written informed consent for study participation
Key exclusion criteria (3 listed)
- ANC visit is not within the final 12 weeks of pregnancy
- Unwilling to provide written informed consent for study participation
- Pregnant woman less than 18 years of age
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 |
|---|---|---|
| Test-it™ PrCr Urinalysis StripsThe LifeAssay Diagnostics prototype PrCr dipstick has been designed to provide the measurement of both protein and creatinine while retaining a very low estimated cost that is comparable to the current protein-only dipsticks at $0.06-0.10 per test. In 2015, an initial laboratory-based validation study of the prototype LAD PrCr test was used on more than 500 characterized urine samples from pregnant women. This validation study demonstrated comparable accuracy for detection of severe proteinuria of the LAD PrCr test to the much more expensive commercial POC test available for PrCr determination, the Siemens Multistix® PRO 10LS. These results were compared to laboratory-based reference standard assays for proteinuria measurement. | Diagnostic test | Pregnant women |
Primary outcome
Accuracy of the PrCr dipstick test compared to a laboratory reference assay (chemistry analyzer measurement of protein and creatinine)
Time frame: September 20198-February 2019
The results of the PrCr dipstick test will be compared to the results of a laboratory reference assay. Sensitivity and specificity analyses will be conducted at thresholds for normal and proteinuria.
Accuracy of the PrCr dipstick test compared to a protein only dipstick.
Time frame: September 20198-February 2019
The results of the PrCr dipstick test will be compared to the results of the protein only test. Sensitivity and specificity analyses will be conducted at thresholds for normal and proteinuria.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Samuel Newton, PhD principal investigator
Kintampo Health Research Centre, Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proteinuria and Preeclampsia, run by PATH at 1 site in Ghana.
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 4 inclusion and 3 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 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy of the PrCr dipstick test compared to a laboratory reference assay (chemistry analyzer measurement of protein and creatinine) (time frame: September 20198-February 2019). The study lists 2 primary outcomes in all. 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 26 Aug 2020.