Efficacy of Combination Therapy for Prevention of Effects of Malaria During Pregnancy
Phase 4
Completed
- Conditions
- Malaria
- Registration Number
- NCT00164255
- Lead Sponsor
- Centers for Disease Control and Prevention
- Brief Summary
This study is an investigation to compare the efficacy of two different intermittent sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine (SP) + artesunate (SP/AS) treatment of HIV negative and positive mothers in clearing placental parasitemia at delivery. If intermittent protective SP/AS treatment is equally efficacious and safe as intermittent protective SP, such a regimen could be adapted for programmatic use as a potentially more durable alternative to SP monotherapy in areas of increasing SP resistance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1614
Inclusion Criteria
- Women 15 years of age or older
- First or second pregnancy between 16 and 36 weeks gestation
Exclusion Criteria
- Pregnancy prior to 16 weeks or after 36 weeks gestation
- Third or later pregnancy;
- Report previous allergic reactions to SP, AS, or unknown antimalarials;
- If the distance to their home is too great or too inaccessible for follow-up;
- Child's father refuses the woman's participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method reported or noted adverse reactions placental parasitemia
- Secondary Outcome Measures
Name Time Method parasitemia at delivery (maternal peripheral, placental and cord) impact of maternal HIV infection on efficacy of malaria prevention during pregnancy maternal illness birth weight gestational age fetal and infant health
Trial Locations
- Locations (2)
Kibaoni Health Centre
🇹🇿Ifakara, Kilombero District, Tanzania
St Francis Designated District Hospital
🇹🇿Ifakara, Kilombero District, Tanzania