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

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Gestational age of at least 16 weeks.

• P. falciparum parasitaemia of any density with or without symptoms.

• Informed consent.

• No known adverse reaction to any of the study drugs.

• Residence in the study area.

Exclusion Criteria:

• 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.

• Haemoglobin concentration below 5.0 g/dl.

• Severe malaria.