Malaria
Conditions
Keywords
malaria, birthweight, placental malaria, intermittent protective treatment, sulfadoxine/ pyrimethamine, artesuate, combination therapy, Pregnancy
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.
Interventions
DRUGsulfadoxine/pyrimethamine plus artesunate
Sponsors
Centers for Disease Control and Prevention
Ifakara Health Research and Development Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| placental parasitemia | — |
| reported or noted adverse reactions | — |
Secondary
| Measure | Time frame |
|---|---|
| birth weight | — |
| gestational age | — |
| parasitemia at delivery (maternal peripheral, placental and cord) | — |
| impact of maternal HIV infection on efficacy of malaria prevention during pregnancy | — |
| fetal and infant health | — |
| maternal illness | — |
Countries
Tanzania
Outcome results
None listed