Status:
COMPLETED
Efficacy and Safety of Sulphadoxine-pyrimethamine and Amodiaquine in Ghanaian Pregnant Women
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Ministry of Health, Ghana
Conditions:
Malaria
Pregnancy
Eligibility:
FEMALE
Phase:
PHASE3
Brief 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 t...
Detailed Description
Primary objective: To determine the effect of AQ, SP and the AQ+SP combination compared with CQ treatment on the prevalence of peripheral parasitaemia on days 14 and 28 post treatment. Secondary obj...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00131703
Start Date
March 1 2003
End Date
March 1 2005
Last Update
March 4 2025
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