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Intermittent Preventative Treatment With Sulfadoxine-pyrimethamine in Gambian Multigravidae
NCT00120809Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2002
- Countries
- 1
- Sponsor
- London School of Hygiene & Tropical Medicine
- Modality
- Small Molecules
- Conditions
- malaria
01
Overview
Phase 3, randomised, double-blind trial in malaria comparing Sulfadoxine-pyrimethamine with Placebo (2 arms). Primary endpoints: Hemoglobin concentration at delivery and Birthweight. Started Jul 2002; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sulfadoxine-pyrimethamine
Participants receive sulfadoxine-pyrimethamine at monthly intervals during the 2nd and 3rd trimesters.
Placebo
Participants receive matching placebo at monthly intervals during the 2nd and 3rd trimesters.
03
Who it enrols
Multigravid pregnant women (>15 weeks gestation) residing in the study area with hemoglobin > 7 g/dL, without allergy to sulfonamides or chronic illness.
04
Endpoints
Primary
Hemoglobin concentration at delivery
Birthweight
Secondary
Hemoglobin concentration six weeks after delivery
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