Efficacy and Safety of Sulphadoxine-pyrimethamine and Amodiaquine in Ghanaian Pregnant Women
Status:
Completed
Trial end date:
2005-03-01
Target enrollment:
Participant gender:
Summary
Malaria in pregnancy is potentially fatal to both the mother and the foetus particularly in
the primigravidae. Implementation of appropriate control and preventive measures is
challenged by the fact that malaria infection in pregnancy is often asymptomatic and
parasitized red blood cells sequestrated in the placental microcirculation may not be
detectable in the peripheral blood. In addition, the widespread prevalence of parasites
resistant to chloroquine and sulphadoxine-pyrimethamine (SP) and, the safety concerns about
newer antimalarials, poverty and inadequate supply have made antimalarial treatment options
available to pregnant women very limited. These have necessitated an urgent search for
alternative safe and efficacious treatment options for pregnant women. The objective of this
study is to assess the efficacy, safety and tolerability of four antimalarial treatment
options in rural Ghana within a programme setting.
Phase:
Phase 3
Details
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborator:
Ministry of Health, Ghana
Treatments:
Amodiaquine Chloroquine Chloroquine diphosphate Fanasil, pyrimethamine drug combination Pyrimethamine Sulfadoxine