Simple malaria test in early pregnancy could save newborns

NCT ID NCT05757167

Prevention Sponsor: Duke University Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether screening pregnant women for malaria with a highly sensitive rapid test during the first trimester, followed by treatment if positive, can improve newborn health. Over 2,000 women in malaria-prone areas will be compared to those receiving usual care. The goal is to reduce complications like low birth weight, preterm birth, and stillbirth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: High-sensitivity malaria rapid diagnostic test and artemether-lumefantrine
What this could lead to: If successful, this could show that early detection and treatment of malaria in pregnancy reduces serious complications like low birth weight and stillbirth.
What could go wrong: This is a single study in one region, and results may not apply everywhere. The test may not catch all infections, and the treatment has side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

2,174 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

malaria Plasmodium falciparum malaria pregnancy disorder with abortive outcome Premature Birth Stillbirth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gestational age and weight conditions Low birthweight Malaria falciparum Malaria in childbirth Malaria in pregnancy Neonatal health Pregnancy Preterm birth Stillbirth

Simple malaria test in early pregnancy could save newborns

What the study statuses mean