Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Aged between 16 years and 40 years (inclusive) * Viable singleton pregnancy with gestational age estimated less than 13 6/7 weeks (inclusive) by ultrasound * HIV-uninfected * Willing to participate in the study schedule * Planning to remain in the study area for the duration of pregnancy and 1 month after delivery * Willing to deliver in a study-affiliated health facility Exclusion Criteria: * High risk pregnancy that requires referral for specialized care by local guidelines * Active medical problem at the time of screening requiring higher level care * Antimalarial receipt in the 2 weeks prior to screening * Past allergy to Artemether or Lumefantrine or another condition that prohibits the receipt of either drug * Current participation in another clinical research study