CompletedNot Applicable

Performance of an Ultrasensible Malaria Rapid Diagnostic Test Among Pregnant Women in Burkina Faso

Burkina Faso288 participantsStarted 2022-10-11

Plain-language summary

The goal of this observational study is to learn about the diagnostic performance of the highly sensitive rapid diagnostic test (HS-RDT) compared to an ultrasensitive qPCR for detection of falciparum malaria in pregnant women attending antenal care (ANC) in Burkina Faso. The main question it aims to answer is: • What are the sensitivity and specificity of the HS-RDT compared to ultrasensitive quantitative polymerase chain reaction (qPCR) considered as gold standard for dection of falciparum malaria in pregnant women attending ANC in Burkina Faso ? Participants will be included during their ANC visits and screened for malaria using the HS\_RDT, the conventional RDT (Co\_RDT), microscopy, and qPCR.

Who can participate

SexFEMALE

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Inclusion Criteria: * Living in Bobo-Dioulasso for at least 6 months before the beginning of the study ; * Provision of informed consent. Exclusion Criteria: * Past history of malaria or antimalarial drugs within the last 3 months ; * Having tested positive for malaria by microscopy or RDT in any previous ANC visit ; * Symptoms and signs of severe malaria as defined by WHO.

What they're measuring

Sensitivity of HS_RDT

Timeframe: At baseline

Specificity of HS_RDT

Timeframe: At baseline

Trial details

NCT IDNCT06572644

SponsorCentre MURAZ/Institut National de Santé Publique

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2022-12-16

View on ClinicalTrials.gov More Malaria,Falciparum trials