drugset / Trial / NCT00131703

Efficacy and Safety of Sulphadoxine-pyrimethamine and Amodiaquine in Ghanaian Pregnant Women

NCT00131703

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2003-03
Primary completion
Completion
2005-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Chloroquine Small molecule
Subject amodiaquine Other / unclassified
Subject sulphadoxine-pyrimethamine Small molecule