Malaria Rapid Diagnostic Tests (RDTs) in Pregnancy: Detection of Placental Malaria

• Conditions: Malaria in Pregnancy; Placental Malaria; Malaria

• Registration Number: NCT01555255
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Brief 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.

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 Timeline

• Study Start: 2010-11
• Primary Completion: 2012-03
• Study First Submitted: 2012-03-14
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-15
• Status Verified: 2012-10
• Study Completion: 2012-12
• Last Update Submitted: 2015-04-22
• Last Update Posted: 2015-04-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1205

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
accuracy of diagnostic tests during gestation	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

Secondary Outcome Measures

Name	Time	Method
association of placental malaria with infant birth weight	at birth
accuracy of diagnostic tests at delivery	at delivery	accuracy of malaria RDTs, peripheral blood smears and PCR performed on maternal peripheral blood to diagnose placental malaria at delivery
association of placental malaria with maternal hemoglobin	twice during gestation and at delivery

Trial Locations

Locations (2)

IRSS, Direction Régionale de l'Ouest; 🇧🇫 Bobo-Dioulasso, Burkina Faso

Tororo District Hospital; 🇺🇬 Tororo, Tororo District, Uganda