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Can a Finger-Prick blood test reveal hidden malaria in the placenta?

NCT ID NCT01555255

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 can hide in the placenta and harm both mother and baby, yet it often goes undetected. This study enrolls about 1,200 pregnant women in Africa to see whether malaria rapid diagnostic tests, blood smears, and PCR on maternal blood can accurately detect or predict placental malaria. Researchers compare these tests during pregnancy and at delivery, and track birth weight and maternal hemoglobin to understand how placental malaria relates to poor outcomes.

What this could mean

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

Active substance
malaria rapid diagnostic tests, blood smears, and PCR on maternal blood
What this could lead to
If the tests prove accurate, clinics could screen pregnant women for placental malaria with a finger-prick blood test and start treatment sooner, which may reduce low birth weight and anemia.
What could go wrong
Peripheral blood tests may miss infections that stay in the placenta, so accuracy could fall short. The study measures test performance, not whether screening improves outcomes, and results may differ across transmission settings.

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

1,205 people

The number who actually took part.

Started

May 2011

Finished

Mar 2012

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

Women presenting for routine antenatal care in the second and third trimesters of pregnancy, at antenatal clinics at ≥2 sites of varied malaria transmission intensity in Africa

Ages

16 to 44 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.

Specific participant selection criteria include: 1. Presenting for care after quickening and before onset of labor (i.e. in the second or third trimester of pregnancy) 2. Age between 16 years and 44 years, inclusive 3. Willingness and ability to follow up with study visits and activities through the duration of pregnancy and at delivery 4. Absence of history of serious adverse reaction to sulfa drugs 5. Absence of history of serious adverse reaction to artemisinin-based drugs (depending on national policy on treatment of malaria in pregnancy) 6. Absence of HIV infection (both because guidelines for malaria prevention in pregnancy for HIV-infected women differ from those for HIV-negative women, and in order to avoid confounding of pregnancy outcomes by HIV-related complications or treatments in this early evaluation) 7. Absence of history of or current obstetrical complications (e.g. pre-eclampsia, eclampsia, hypertension during pregnancy, post-partum hemorrhage, evidence of multiple gestation) 8. Absence of chronic disease (e.g. diabetes mellitus, sickle cell disease) 9. Absence of evidence of severe acute disease requiring inpatient management or referral 10. Provision of written informed consent 11. Enrollment Hb ≥7 g/dL

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Conditions

The condition(s) this trial relates to.

anemia Birth Weight malaria

As listed by the trial registrant

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

Malaria Malaria in pregnancy Placental malaria

Contacts and locations

Locations

  • IRSS, Direction Régionale de l'Ouest

    Bobo-Dioulasso, 01BP 545, Burkina Faso

  • Tororo District Hospital

    Tororo, Tororo District, 0, Uganda

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