Malaria in Pregnancy Clinical Trial
Official title:
Assessment of the Efficacy and Effectiveness of Sulphadoxine-pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Malawi
The purpose of this study is to determine the efficacy and effectiveness of sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy for reducing malaria-associated morbidity in pregnant women in Malawi.
Status | Completed |
Enrollment | 1410 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Therapeutic efficacy study Inclusion Criteria: - 16-26 weeks gestation based on last menstrual period (LMP) or quickening - Axillary temperature <37.5 degrees Celsius - Informed consent Exclusion Criteria: - History of hypersensitivity reaction to SP or components of SP - Axillary temperature =37.5 degrees C - History of receipt of antimalarials in the past month - Known HIV infection Birth outcomes study: Inclusion Criteria: - Singleton pregnancy - SP IPTp history available - Informed consent Exclusion Criteria: - Blood transfusion after the 16th gestational week - Receipt of antimalarials other than SP for IPTp after 16th gestational week - Known HIV infection Characterizing molecular markers of SP resistance: Inclusion Criteria: - Outpatient attending selected health facility - Informed consent Exclusion Criteria: |
Observational Model: Cohort
Country | Name | City | State |
---|---|---|---|
Malawi | Machinga District Hospital | Liwonde | Machinga District |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control and Prevention | University of Malawi College of Medicine |
Malawi,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Therapeutic efficacy study: Development of fever or symptoms of severe malaria (defined by WHO) and parasitemia at any time after the first dose of SP during the 42 day follow up period | 42 days | No | |
Primary | Birth outcomes study: Evidence of malaria infection based on placental histology at the time of delivery | At time of birth | No | |
Primary | Characterizing molecular markers of SP resistance: Prevalence of molecular markers of sulphadoxine-pyrimethamine resistance at the time of health facility visit | Day 1 | No |
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