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Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Sponsor: Duke University
Summary
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.
Official title: Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity
Key Details
Gender
FEMALE
Age Range
16 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
2500
Start Date
2023-11-06
Completion Date
2027-02
Last Updated
2026-01-20
Healthy Volunteers
No
Conditions
Interventions
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
Locations (2)
Kinshasa School of Public Health
Kinshasa, Democratic Republic of the Congo
Moi University
Eldoret, Kenya