Status:
UNKNOWN
Clinical Performance of the Histidine Rich Protein 2 (HRP2) Highly Sensitive Rapid Diagnostic Test (HS-RDT) for Malaria Diagnosis in Pregnant Women in Papua New Guinea
Lead Sponsor:
Foundation for Innovative New Diagnostics, Switzerland
Collaborating Sponsors:
Burnet Institute
Papua New Guinea Institute of Medical Research
Conditions:
Plasmodium Falciparum Malaria
Pregnancy Malaria
Eligibility:
FEMALE
16+ years
Brief Summary
Malaria during pregnancy remains an important public health issue in endemic countries. Most cases of malaria in pregnant women are asymptomatic, and can contribute to adverse outcomes, such as matern...
Eligibility Criteria
Inclusion
- All women must meet all the following inclusion criteria in order to be eligible to participate in the study:
- Pregnant women attending first antenatal care visit at selected health facilities
- Resident in the study area for at least 1 year prior to enrolment
- Age ≥ 16
- Willing to freely participate with signed informed consent (or, if illiterate, provide a thumbprint in the presence of an independent witness)
- Willing to provide finger-prick blood sample
Exclusion
- Women meeting any of the following exclusion criteria at screening will be excluded from study participation:
- History of malaria or antimalarial drugs used in the last three months, as recalled or documented in health record
- Presence of severe malaria as defined by WHO guidelines at the moment of recruitment.
- Presence of symptoms and signs of other serious chronic disease such as severe anaemia, tuberculosis and/or central nervous system infections, as defined by WHO guidelines
Key Trial Info
Start Date :
April 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2018
Estimated Enrollment :
930 Patients enrolled
Trial Details
Trial ID
NCT03462615
Start Date
April 1 2018
End Date
October 1 2018
Last Update
March 12 2018
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