Malaria Rapid Diagnostic Tests (RDTs) in Pregnancy: Detection of Placental Malaria
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Purpose
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.
| Condition |
|---|
|
Malaria Placental Malaria Malaria in Pregnancy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Malaria Rapid Diagnostic Tests (RDTs) in Pregnancy: Detection of Placental Malaria |
- accuracy of diagnostic tests during gestation [ Time Frame: 2nd trimester of pregnancy ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]accuracy of malaria RDTs, blood smears and PCR performed on maternal peripheral blood to diagnose or predict placental malaria during gestation
- association of placental malaria with infant birth weight [ Time Frame: at birth ] [ Designated as safety issue: No ]
- association of placental malaria with maternal hemoglobin [ Time Frame: twice during gestation and at delivery ] [ Designated as safety issue: No ]
- accuracy of diagnostic tests at delivery [ Time Frame: at delivery ] [ Designated as safety issue: No ]accuracy of malaria RDTs, peripheral blood smears and PCR performed on maternal peripheral blood to diagnose placental malaria at delivery
Biospecimen Retention: Samples With DNA
Red cell pellets, dried whole blood on filter paper, and fixed blood and placental tissue
| Estimated Enrollment: | 1205 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 16 Years to 44 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations| Burkina Faso | |
| IRSS, Direction Régionale de l'Ouest | |
| Bobo-Dioulasso, Burkina Faso, 01BP 545 | |
| Uganda | |
| Tororo District Hospital | |
| Tororo, Tororo District, Uganda, 0 | |
| Principal Investigator: | Heidi A Hopkins, MD | Foundation for Innovative New Diagnostics, Kampala, Uganda |
| Principal Investigator: | Jean-Bosco Ouedraogo, MD, PhD | IRSS, Direction Regionale de l'Ouest, Bobo-Dioulasso, Burkina Faso |
| Study Director: | David Bell, MBBS, PhD | Foundation for Innovative New Diagnostics, Geneva, Switzerland |
| Study Director: | Jane Cunningham, MD | UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), Geneva, Switzerland |
| Principal Investigator: | Miriam Nakalembe, MBChB | Makerere University Faculty of Medicine, Kampala, Uganda |
More Information
No publications provided
| Responsible Party: | Heidi Hopkins, Principal Investigator, Foundation for Innovative New Diagnostics, Switzerland |
| ClinicalTrials.gov Identifier: | NCT01555255 History of Changes |
| Other Study ID Numbers: | RPC390 |
| Study First Received: | March 14, 2012 |
| Last Updated: | October 2, 2012 |
| Health Authority: | Burkina Faso: Centre Muraz, Comite d'Ethique, Ministere de la Sante Uganda: National Council for Science & Technology (UNCST) |
Keywords provided by Foundation for Innovative New Diagnostics, Switzerland:
|
malaria pregnancy placental malaria |
malaria in pregnancy birth weight anemia |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013