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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 16
Maximum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Democratic Republic of the Congo
Kinshasa School of Public Health
RECRUITING
Kinshasa
Kenya
Moi University
RECRUITING
Eldoret
Contact Information
Primary
Stephen James, MPH
stephen.james@duke.edu
919-668-0420
Backup
Irene Okumu
irene.okumu@duke.edu
919-660-6321
Time Frame
Start Date: 2023-11-06
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 2500
Treatments
Experimental: HS-RDT screening/AL treatment
Pregnant women will be screened with a malaria HS-RDT and, if positive, treated with artemether-lumefantrine
No_intervention: Usual antenatal care
Pregnant women will receive usual antenatal care
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Leads: Duke University

This content was sourced from clinicaltrials.gov