Efficacy and Safety of Sulphadoxine-Pyrimethamine and Amodiaquine in Ghanaian Pregnant Women
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- Prevalence of parasitaemia on day 28 post treatment.
- Prevalence of parasitaemia on day 14 post treatment.
- Incidence of adverse drug events within seven days following treatment.
- Proportions of pregnant women withdrawn from the study due to the occurrence of adverse drug events (clinical and laboratory) by day 7 following initiation of treatment.
- Change in maternal haemoglobin concentrations at days 14 and 28 following treatment.
- Prevalence of peripheral parasitaemia at delivery.
- Prevalence of placental parasitaemia at delivery.
- Proportions of abnormal biochemistry and white blood cell values on days 14 and 28 post treatment.
- Sensitivity, specificity, positive and negative predictive values, likelihood ratios, and the area under receiver operating characteristic (ROC) curve for the OptiMAL antigen test.
- Incidences of adverse pregnancy outcomes in the study group.
- Prevalence of postpartum parasitaemia.
- Prevalence of postpartum anaemia.
|Study Start Date:||March 2003|
|Estimated Study Completion Date:||March 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131703
|Principal Investigator:||Harry K Tagbor, MD||London School of Hygiene and Tropical Medicine|