Malaria Clinical Trial
Official title:
Malaria Rapid Diagnostic Tests (RDTs) in Pregnancy: Detection of Placental Malaria
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.
Status | Active, not recruiting |
Enrollment | 1205 |
Est. completion date | December 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years to 44 Years |
Eligibility |
Specific participant selection criteria include: 1. Presenting for care after quickening and before onset of labor (i.e. in the second or third trimester of pregnancy) 2. Age between 16 years and 44 years, inclusive 3. Willingness and ability to follow up with study visits and activities through the duration of pregnancy and at delivery 4. Absence of history of serious adverse reaction to sulfa drugs 5. Absence of history of serious adverse reaction to artemisinin-based drugs (depending on national policy on treatment of malaria in pregnancy) 6. 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) 7. Absence of history of or current obstetrical complications (e.g. pre-eclampsia, eclampsia, hypertension during pregnancy, post-partum hemorrhage, evidence of multiple gestation) 8. Absence of chronic disease (e.g. diabetes mellitus, sickle cell disease) 9. Absence of evidence of severe acute disease requiring inpatient management or referral 10. Provision of written informed consent 11. Enrollment Hb =7 g/dL |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Burkina Faso | IRSS, Direction Régionale de l'Ouest | Bobo-Dioulasso | |
Uganda | Tororo District Hospital | Tororo | Tororo District |
Lead Sponsor | Collaborator |
---|---|
Foundation for Innovative New Diagnostics, Switzerland | UNICEF, United Nations Development Programme, World Bank, World Health Organization |
Burkina Faso, Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 2nd trimester of pregnancy | No |
Primary | 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 | 3rd trimester of pregnancy | No |
Secondary | association of placental malaria with infant birth weight | at birth | No | |
Secondary | association of placental malaria with maternal hemoglobin | twice during gestation and at delivery | No | |
Secondary | 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 | at delivery | No |
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