Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity
About This Trial
The purpose of the INTREPiD study is to compare 1st trimester screening for malaria parasites with a high-sensitivity malaria rapid diagnostic test followed by treatment of test-positive women with artemether-lumefantrine (AL) against usual antenatal care on a composite adverse pregnancy outcome including low birth weight, small for gestational age, preterm, fetal loss, or neonatal death.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT)
Detection of Plasmodium falciparum HRP-II antigen1 Method: Lateral Flow; Time to Result: 20 minutes; Sample Type: Fingerstick Whole Blood; Sample Volume: 5µl; Storage Conditions: 1-30°C; Shelf Life: 12 months; Sensitivity/Specificity: 99.0%/98.6%
Artemether-lumefantrine (AL)
oral tablets: 6 doses of 80/480 mg over 3 days