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

Launched by DUKE UNIVERSITY · Feb 24, 2023

Keywords

ClinConnect Summary

The INTREPiD study is a clinical trial aimed at improving the health of newborns by testing pregnant women for malaria early in their pregnancy. Researchers want to see if using a special, highly sensitive test for malaria in the first trimester, followed by treatment for those who test positive, can lead to better pregnancy outcomes compared to the usual care. They are particularly looking at factors like low birth weight, premature births, and other serious issues that can affect the baby’s health.

To be eligible for this study, women need to be between 16 and 40 years old, be in the early stages of a healthy pregnancy (less than 13 weeks along), and not have HIV. Participants should also be willing to stay in the area for their entire pregnancy and deliver at a facility involved in the study. If someone joins the study, they can expect regular follow-ups and care as part of the research. This trial is important because it could help reduce the risks associated with malaria during pregnancy, ultimately leading to healthier babies.

Gender

FEMALE

Eligibility 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