Pregnancy Clinical Trial
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
Verified date | January 2017 |
Source | London School of Hygiene and Tropical Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | Ghana: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 900 |
Est. completion date | March 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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London School of Hygiene and Tropical Medicine | Ministry of Health, Ghana |
Tagbor H, Bruce J, Browne E, Randal A, Greenwood B, Chandramohan D. Efficacy, safety, and tolerability of amodiaquine plus sulphadoxine-pyrimethamine used alone or in combination for malaria treatment in pregnancy: a randomised trial. Lancet. 2006 Oct 14; — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of parasitaemia on day 28 post treatment. | |||
Primary | Prevalence of parasitaemia on day 14 post treatment. | |||
Secondary | Incidence of adverse drug events within seven days following treatment. | |||
Secondary | 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. | |||
Secondary | Change in maternal haemoglobin concentrations at days 14 and 28 following treatment. | |||
Secondary | Prevalence of peripheral parasitaemia at delivery. | |||
Secondary | Prevalence of placental parasitaemia at delivery. | |||
Secondary | Proportions of abnormal biochemistry and white blood cell values on days 14 and 28 post treatment. | |||
Secondary | Sensitivity, specificity, positive and negative predictive values, likelihood ratios, and the area under receiver operating characteristic (ROC) curve for the OptiMAL antigen test. | |||
Secondary | Incidences of adverse pregnancy outcomes in the study group. | |||
Secondary | Prevalence of postpartum parasitaemia. | |||
Secondary | Prevalence of postpartum anaemia. |
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