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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIAGNOSTIC_TEST

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%

DRUG

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