NCT05757167

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 16 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

INTREPiD is a two-arm, open-label, parallel-assignment randomized trial of a strategy of 1st trimester screening for P. falciparum parasites with a high-sensitivity rapid diagnostic test (HS-RDT). Participants will be women of all gravidities presenting to antenatal clinics in the 1st trimester in sites endemic for P. falciparum malaria in Kenya and the Democratic Republic of the Congo. Following consent and enrollment, women will be allocated 1:1 to either usual antenatal care or to the intervention. The intervention will be a single screening in the 1st trimester for P. falciparum infection in maternal peripheral blood with a HS-RDT. Women who test positive for P. falciparum on HS-RDT testing will be treated with a single course of Artemether-Lumefantrine (AL) and then returned to usual antenatal care. Participants will be followed through delivery and then through their offspring's first month of life. The Hypothesis is that, compared to usual antenatal care, screening women in the 1st trimester for P. falciparum and treating them if positive with AL will reduce the risk of an adverse pregnancy outcome.

Conditions

• Malaria,Falciparum
• Malaria in Pregnancy
• Malaria in Childbirth
• Pregnancy
• Neonatal Health
• Low Birthweight
• Stillbirth
• Gestational Age and Weight Conditions
• Preterm Birth

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-06
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2023-03-07
• Last updated: 2026-01-20

Locations

2 sites across 2 countries: Democratic Republic of the Congo, Kenya