Efficacy and Safety of Sulphadoxine-pyrimethamine and Amodiaquine in Ghanaian Pregnant Women
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ClinicalTrials.gov Identifier: NCT00131703
Recruitment Status :
First Posted : August 19, 2005
Last Update Posted : January 12, 2017
London School of Hygiene and Tropical Medicine
Ministry of Health, Ghana
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine
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.
A Randomised Double Blind Clinical Trial of Amodiaquine (AQ) and Sulphadoxine-pyrimethamine (SP) Used Singly and in Combination (AQ+SP) Compared With Chloroquine (CQ) in the Treatment of Falciparum Malaria Infection in Pregnancy
Study Start Date :
Study Completion Date :
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Ages Eligible for Study:
Child, Adult, Senior
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Gestational age of at least 16 weeks.
P. falciparum parasitaemia of any density with or without symptoms.
No known adverse reaction to any of the study drugs.
Residence in the study area.
Past obstetric and medical history that might adversely affect the interpretation of outcomes such as repeated stillbirths and eclampsia.
History of severe adverse drug reactions to co-trimoxazole in the past.