In areas of stable transmission, pregnant women, especially during the first and second
pregnancies, have an increased susceptibility to Plasmodium falciparum malaria,
malaria-related anaemia and an increased risk of having low birthweight babies. Intermittent
Preventive Treatment in pregnancy(IPTp) with sulphadoxine-pyrimethamine has been shown to be
effective in reducing the effects of malaria in pregnancy. This has mainly been in areas of
perennial transmission and there is a need to study this effect in intense seasonal
transmission settings. The emergence and spread of resistance to SP is likely to undermine
its useful lifespan and it is important that other antimalarials that are safe and effective
are identified for use in IPTp. The options are however limited. Amodiaquine has been shown
to be effective in treatment of clinical cases of malaria, even in areas where chloroquine
resistance is prevalent, and its combination with SP has been associated with favourable
results. Both are affordable. However, there is limited data on their use in pregnancy. This
study aims to assess the efficacy of SP in an area of intense seasonal transmission, and
evaluate the safety and efficacy of amodiaquine and a combination of
sulphadoxine-pyrimethamine and amodiaquine as possible alternatives to SP for use as IPTp.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Gates Malaria Partnership London School of Hygiene and Tropical Medicine
Collaborator:
Ministry of Health, Ghana
Treatments:
Amodiaquine Fanasil, pyrimethamine drug combination Pyrimethamine Sulfadoxine