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New malaria test aims to catch hidden infections in pregnant women

NCT ID NCT03462615

Diagnosis Sponsor: Foundation for Innovative New Diagnostics, Switzerland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Malaria in pregnancy often causes no symptoms, yet it can lead to anaemia, premature birth, and low birth weight. Standard rapid tests miss many of these quiet infections. Researchers are comparing a new high-sensitivity rapid diagnostic test with conventional tests in 930 pregnant women in Papua New Guinea. The study measures how well the new test detects malaria parasites compared with a lab reference method.

What this could mean

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

Active substance
a high-sensitivity rapid diagnostic test for malaria (HS-RDT)
What this could lead to
If the test performs well, it could give clinics a simple finger-prick tool to find malaria infections that standard tests miss in pregnant women, helping to prevent complications like anaemia and low birth weight.
What could go wrong
The test may not detect enough infections in practice, or it could produce false positives that lead to unnecessary worry. The study only checks how well the test works, not whether using it improves health outcomes.

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.

Participants

930 people

The number who actually took part.

Started

Aug 2018

Finished

May 2019

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.

Who is studied

The study will test samples from pregnant women aged 16 and older, self-presenting at health centres for antenatal care in this malaria-endemic setting

Ages

16 years and older

Sex

Female participants only

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: * All women must meet all the following inclusion criteria in order to be eligible to participate in the study: * Pregnant women attending first antenatal care visit at selected health facilities * Resident in the study area for at least 1 year prior to enrolment * Age ≥ 16 * Willing to freely participate with signed informed consent (or, if illiterate, provide a thumbprint in the presence of an independent witness) * Willing to provide finger-prick blood sample Exclusion Criteria: * Women meeting any of the following exclusion criteria at screening will be excluded from study participation: * History of malaria or antimalarial drugs used in the last three months, as recalled or documented in health record * Presence of severe malaria as defined by WHO guidelines at the moment of recruitment. Presence of symptoms and signs of other serious chronic disease such as severe anaemia, tuberculosis and/or central nervous system infections, as defined by WHO guidelines

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Conditions

The condition(s) this trial relates to.

disease malaria Plasmodium falciparum malaria

As listed by the trial registrant

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

Diagnoses disease Plasmodium falciparum malaria Pregnancy malaria

Contacts and locations

Locations

  • Nonga General Hospital

    Rabaul, East New Britain Province, Papua New Guinea

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