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).
A research project aiming at investigating the impact of multivitamin-mineral
supplementation (MMS) during pregnancy on intra-uterin growth retardation was carried out in
the Hounde district, an area not far from the Centre Muraz located in Bobo Dioulasso, and
where malaria is endemic. Malaria during pregnancy increases the risk of low birth weight,
infant mortality and morbidity during the first year of life by inducing growth retardation,
prematurity and infant anaemia.
The administration of an antimalarial drug during pregnancy has a beneficial effect on the
mother and child's health by preventing malaria infection and its consequences. However,
most studies have been carried out during the second or third trimester of pregnancy: the
effect of malaria infection during the first trimester on the mother's and child's health is
unknown. It has been reported that even one single infection may have a significant impact
on the outcome of pregnancy: if it is true, then early chemoprophylaxis may have an
additional advantage.
An alternative approach is the administration of intermittent presumptive treatment, which
may achieve equal efficacy to continuos chemoprophylaxis; however, no studies compared
effective weekly malaria chemoprophylaxis with effective intermittent presumptive treatment.
Moreover, the incidence of malaria clinical episodes during SP intermittent preventive
treatment has never been investigated.
Therefore, this open label, factorial study was carried out in the same women recruited for
the IUGR nutritional study (NCT00642408). Women receiving multiple micronutrients
supplements (MMS) or dietary supplements (IFA) were further randomised in 2 groups: CQ
weekly chemoprophylaxis or SP intermittent preventive treatment. The administration of
treatment was directly observed.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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