MalariaNCT01555255
Malaria Rapid Diagnostic Tests (RDTs) in Pregnancy: Detection of Placental Malaria
An observational study of Malaria and Placental Malaria, run by Foundation for Innovative New Diagnostics, Switzerland at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 44 years, women only
- Conditions the study is for
- Malaria, Placental Malaria, Malaria in Pregnancy
- How many people
- 1,205 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2011to 30 Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: 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:
- Presenting for care after quickening and before onset of labor (i.e. in the second or third trimester of pregnancy)
- Age between 16 years and 44 years, inclusive
- Willingness and ability to follow up with study visits and activities through the duration of pregnancy and at delivery
- Absence of history of serious adverse reaction to sulfa drugs
- Absence of history of serious adverse reaction to artemisinin-based drugs (depending on national policy on treatment of malaria in pregnancy)
- 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)
- Absence of history of or current obstetrical complications (e.g. pre-eclampsia, eclampsia, hypertension during pregnancy, post-partum hemorrhage, evidence of multiple gestation)
- Absence of chronic disease (e.g. diabetes mellitus, sickle cell disease)
- Absence of evidence of severe acute disease requiring inpatient management or referral
- Provision of written informed consent
- Enrollment Hb ≥7 g/dL
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Burkina Faso1 site
IRSS, Direction Régionale de l'Ouest
Bobo-Dioulasso, 01BP 545
About this study
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.
Read the detailed description
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.
- Conditions
- Malaria, Placental Malaria, Malaria in Pregnancy
- Keywords
- malaria, pregnancy, placental malaria, malaria in pregnancy, birth weight, anemia
- Medical subject headings
- Malaria, Birth Weight, Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3rd trimester of pregnancy
Secondary outcomes (3)
association of placental malaria with infant birth weight
Measured: at birth
association of placental malaria with maternal hemoglobin
Measured: 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
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study start1 May 2011
- Primary completion30 Mar 2012
- Study completion30 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF, World Bank, World Health Organization
- Responsible party
- Sponsor
- Investigators
- Heidi A Hopkins, MD, Principal investigator, Foundation for Innovative New Diagnostics, Kampala, UgandaJean-Bosco Ouedraogo, MD, PhD, Principal investigator, IRSS, Direction Regionale de l'Ouest, Bobo-Dioulasso, Burkina FasoDavid Bell, MBBS, PhD, Study director, Foundation for Innovative New Diagnostics, Geneva, SwitzerlandJane Cunningham, MD, Study director, UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), Geneva, SwitzerlandMiriam Nakalembe, MBChB, Principal investigator, Makerere University Faculty of Medicine, Kampala, Uganda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555255
- Sponsor's protocol ID
- RPC390
- Status last verified
- Sep 2026
- First submitted
- 14 Mar 2012
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Canier L, Khim N, Kim S, Sluydts V, Heng S, Dourng D, Eam R, Chy S, Khean C, Loch K, Ken M, Lim H, Siv S, Tho S, Masse-Navette P, Gryseels C, Uk S, Van Roey K, Grietens KP, Sokny M, Thavrin B, Chuor CM, Deubel V, Durnez L, Coosemans M, Menard D. An innovative tool for moving malaria PCR detection of parasite reservoir into the field. Malar J. 2013 Nov 9;12:405. doi: 10.1186/1475-2875-12-405.
PubMed 24206649
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malaria Rapid Diagnostic Tests (RDTs) in Pregnancy: Detection of Placental Malaria
- ClinicalTrials.gov ID
- NCT01555255
- Acronym / sponsor ID
- RPC390
- Conditions
- Malaria, Placental Malaria, Malaria in Pregnancy
- Keywords
- malaria, pregnancy, placental malaria, malaria in pregnancy, birth weight, anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,205 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- UNICEF, World Bank, World Health Organization
- Study start
- 1 May 2011 (actual)
- Primary completion
- 30 Mar 2012 (actual)
- Study completion
- 30 Mar 2012 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
accuracy of diagnostic tests during gestation
Time frame: 2nd trimester of pregnancy
accuracy of malaria RDTs, blood smears and PCR performed on maternal peripheral blood to diagnose or predict placental malaria during gestation
accuracy of diagnostic tests during gestation
Time frame: 3rd trimester of pregnancy
accuracy of malaria RDTs, blood smears and PCR performed on maternal peripheral blood to diagnose or predict placental malaria during gestation
3 secondary outcomes
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
Time frame: at delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 24206649Canier L, Khim N, Kim S, Sluydts V, Heng S, Dourng D, Eam R, Chy S, Khean C, Loch K, Ken M, Lim H, Siv S, Tho S, Masse-Navette P, Gryseels C, Uk S, Van Roey K, Grietens KP, Sokny M, Thavrin B, Chuor CM, Deubel V, Durnez L, Coosemans M, Menard D. An innovative tool for moving malaria PCR detection of parasite reservoir into the field. Malar J. 2013 Nov 9;12:405. doi: 10.1186/1475-2875-12-405.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi A Hopkins, MD principal investigator
Foundation for Innovative New Diagnostics, Kampala, Uganda
Jean-Bosco Ouedraogo, MD, PhD principal investigator
IRSS, Direction Regionale de l'Ouest, Bobo-Dioulasso, Burkina Faso
David Bell, MBBS, PhD study director
Foundation for Innovative New Diagnostics, Geneva, Switzerland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and Placental Malaria, run by Foundation for Innovative New Diagnostics, Switzerland at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burkina Faso, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of diagnostic tests during gestation (time frame: 2nd trimester of pregnancy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01555255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.