drugset / Trial / NCT00142207
Preventing Malaria During Pregnancy in Epidemic-prone Areas.
Phase 3
Completed
4775 enrolled
London School of Hygiene and Tropical Medicine
Ministry of Health, Uganda · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to compare the efficacy and cost-effectiveness of three alternative strategies for the prevention of malaria during pregnancy in an epidemic-prone area of low transmission in the East African Highlands. The strategies being compared are: * intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP) * an insecticide treated net (ITN), and * intermittent preventive treatment with SP plus an ITN In addition to the main individually-randomised trial, outcome data was subsequently also gathered on pregnant women whose houses where sprayed with indoor residual insecticides (IRS) as part of a non-randomised district-wide control programme to compare the impact of IRS with the three intervention arms.
Timeline
- Start
- 2004-01
- Primary completion
- 2007-01
- Completion
- 2007-01
Publications
- Background Ndyomugyenyi R, Clarke S, Chandramohan D, Twesigomwe T & Magnussen P. (2005). Epidemiology of pregnancy-associated malaria in the Ugandan highlands [abstract]. Acta Tropica, Suppl 95: S448.
- Hansen KS, Ndyomugyenyi R, Magnussen P, Clarke SE. Cost-effectiveness analysis of three health interventions to prevent malaria in pregnancy in an area of low transmission in Uganda. Int Health. 2012 Mar;4(1):38-46. doi: 10.1016/j.inhe.2011.10.001.
- Ndyomugyenyi R, Clarke SE, Hutchison CL, Hansen KS, Magnussen P. Efficacy of malaria prevention during pregnancy in an area of low and unstable transmission: an individually-randomised placebo-controlled trial using intermittent preventive treatment and insecticide-treated nets in the Kabale Highlands, southwestern Uganda. Trans R Soc Trop Med Hyg. 2011 Nov;105(11):607-16. doi: 10.1016/j.trstmh.2011.07.012. Epub 2011 Oct 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | sulfadoxine/pyrimethamine | Unknown | — | Oral |