An observational study in Plasmodium Falciparum Malaria, Pregnancy Malaria and Diagnoses Disease, sponsored by Foundation for Innovative New Diagnostics, Switzerland. Completed at 1 site in Papua New Guinea. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Foundation for Innovative New Diagnostics, Switzerland · Observational
Malaria during pregnancy remains an important public health issue in endemic countries. Most cases of malaria in pregnant women are asymptomatic, and can contribute to adverse outcomes, such as maternal and neonatal anaemia as well as low birth weight. Infections that do not cause symptoms (sub-clinical infections) - particularly in low transmission settings -remain difficult to diagnose during pregnancy but can contribute to adverse outcomes e.g. growth restriction, premature birth, miscarriage and stillbirth.
The Bill \& Melinda Gates Foundation (BMGF) has supported the development of an HRP2-based high sensitivity rapid diagnostic tests (HS-RDT) that has analytical sensitivity ten times better than current RDTs and a sensitivity near 80% when compared to the 'gold standard' of quantitative polymerase chain reaction (qPCR). In this regard, the new HS-RDT may be a promising diagnostic and screening test for subclinical malaria during pregnancy.
The overall aim is to compare the performance of novel high sensitivity rapid detection tests with conventional rapid diagnostic tests for Plasmodium falciparum malaria infection in pregnant women in Papua New Guinea
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's enrollment of 930 is above the median of 561 across 63 observational studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum 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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All women must meet all the following inclusion criteria in order to be eligible to participate in the study:
Exclusion Criteria:
Women meeting any of the following exclusion criteria at screening will be excluded from study participation:
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
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.
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.
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.
A single finger-prick blood sample will be collected and used to test participants with the HS-RDT. The results of the results of the test will not be used for treatment purposes nor used to inform patient care.
Also known as: ultra sensitive RDT
Sensitivity, specificity, negative predictive value and positive predictive value
1.1 Estimates of sensitivity, specificity, negative predictive value, positive predictive value, and diagnostic odds ratio of HRP2 HS-RDT for the detection of P. falciparum during pregnancy, compared with conventional good quality RDTs, microscopy and LAMP in peripheral blood with qPCR as reference test.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Foundation for Innovative New Diagnostics, Switzerland