Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Artemether; Artemether, Lumefantrine Drug Combination; Lumefantrine

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