An observational study in Malaria, Placental Malaria and Malaria in Pregnancy, sponsored by Foundation for Innovative New Diagnostics, Switzerland. Completed at 2 sites in 2 countries. Open to female participants aged 16 Years to 44 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Foundation for Innovative New Diagnostics, Switzerland · Observational
This study seeks to determine whether screening pregnant women for malaria with malaria rapid diagnostic tests (RDTs) may detect placental infection and predict risk of poor birth outcomes due to malaria in areas of varied malaria transmission in Africa.
Malaria prevention measures for pregnant women are critical and available, but the effectiveness of intermittent preventive treatment (IPTp) with sulfadoxine-pyrimethamine, a cornerstone in this prevention effort, is declining with increasing parasite resistance. New drugs for IPTp are being considered, but there are disadvantages to presumptive use of the few remaining efficacious antimalarials. An alternative approach may involve screening with diagnostic tests to better target efficacious antimalarial treatment to asymptomatic women with laboratory evidence of malaria infection. Light microscopy of peripheral maternal blood misses a large proportion of cases, and PCR is unavailable in routine health care settings. Preliminary evidence suggests that detection of parasite antigen in peripheral blood may provide an accurate indicator of clinically significant infections and predict pregnancy outcomes. Therefore, screening with RDTs may offer an accurate and practical way to identify pregnant women who will benefit from targeted therapy for placental malaria infection. Antigen detection thresholds vary widely among RDTs, and the distribution of target antigens in peripheral blood circulation is expected to differ; therefore, the potential value of RDTs in this population can best be established by evaluating the detection of placental parasitemia for highly-characterized RDTs, enabling results to be extrapolated to other products and programs. The study described here is proposed to address this question.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 1,205 is above the median of 582 across 204 observational studies indexed under Malaria.
Browse Malaria studies →Foundation for Innovative New Diagnostics, Switzerland is the lead sponsor of 61 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Specific participant selection criteria include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
accuracy of diagnostic tests during gestation
accuracy of malaria RDTs, blood smears and PCR performed on maternal peripheral blood to diagnose or predict placental malaria during gestation
Time frame: 2nd trimester of pregnancy
accuracy of diagnostic tests during gestation
accuracy of malaria RDTs, blood smears and PCR performed on maternal peripheral blood to diagnose or predict placental malaria during gestation
Time frame: 3rd trimester of pregnancy
association of placental malaria with infant birth weight
Time frame: at birth
association of placental malaria with maternal hemoglobin
Time frame: twice during gestation and at delivery
accuracy of diagnostic tests at delivery
accuracy of malaria RDTs, peripheral blood smears and PCR performed on maternal peripheral blood to diagnose placental malaria at delivery
Time frame: at delivery
Ran from May 2011 to primary completion in Mar 2012, 10 months.
Of 85 non-industry observational studies under Malaria, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 36. This study's 10 months is below that.
Counting every sponsor, half of 93 studies reached it within 24 months; a quarter within 16 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Foundation for Innovative New Diagnostics, Switzerland