Malaria Clinical Trial
Official title:
Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso: the Malaria Component
Our objective was to investigate the importance of malaria infection/disease during pregnancy and more particularly during the first trimester; we also looked at the maternal-foetal interactions and their influence on the subsequent child's response to malaria infections during the first year of life. This study was carried out !in the same population recruited for the IUGR study (NCT00642408).
Status | Completed |
Enrollment | 1370 |
Est. completion date | October 2006 |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 15 Years to 44 Years |
Eligibility |
Inclusion Criteria: - 15 to 44 years - females - living in the study area Exclusion Criteria: - planning to move outside the district within two years - regularly using a contraceptive methods - already pregnant at the start of the trial |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Burkina Faso | Centre Muraz | Bobo-Dioulasso |
Lead Sponsor | Collaborator |
---|---|
Institute of Tropical Medicine, Belgium | Centre Muraz, Departments of Parasitology and Public Health, ITM, Antwerp, Belgium, Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso |
Burkina Faso,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of standard antimalarial treatment in preventing clinical malaria in pregnant women under weekly chemoprophylaxis or intermittent treatment. | Up to delivery | No | |
Secondary | To determine if the occurrence of malaria during pregnancy influences the incidence of clinical malaria in infants during their first year of life. | Up to one year after delivery | Yes | |
Secondary | To determine the burden of clinical malaria during pregnancy and its consequences on maternal anaemia, new birth weight and foetal anaemia. | Up to delivery | Yes | |
Secondary | Effect of standard antimalarial treatment on the selection of resistant parasites in pregnant women under weekly chemoprophylaxis or intermittent treatment. | Up to one year after delivery | No |
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