Preeclampsia Clinical Trial
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:
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.
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.
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