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
Duke University
2,500 participants
Nov 6, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria5
- 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
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Interventions
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%
oral tablets: 6 doses of 80/480 mg over 3 days
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05757167