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Sponsors and Collaborators: |
Gates Malaria Partnership DBL -Institute for Health Research and Development Ministry of Health, Uganda |
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Information provided by: | Gates Malaria Partnership |
ClinicalTrials.gov Identifier: | NCT00118027 |
SUMMARY
Background: Malaria is the leading cause of morbidity and mortality among pregnant women in Uganda. Although effective tools for prevention and control of malaria exist, their delivery presents a problem. Intermittent presumptive treatment (IPT) with sulfadoxine-pyrimethamine (SP) is effective, yet >60% of women in Uganda do not get it as < 40%, attend antenatal care. Effective ways of delivering IPT with SP to pregnant women at a community level need to be developed. This study assessed whether community based resource persons like traditional birth attendants (TBAs), community reproductive health workers (CRHWs), adolescent peer mobilizers (APMs) and drug-shop owners (DSV) can distribute IPT with SP to pregnant women.
Objectives: The objectives of this study were:
Methods: The study was conducted in 5 sub-counties of the Mukono district, situated on the shores of L. Victoria in Central Uganda. The district is hyper-endemic for malaria. 25 parishes with a total population of 75,000 people were used to test the new approaches. Phase 1 obtained qualitative data on community perceptions, beliefs and practices associated with malaria prevention in pregnancy. Phase 2 was an intervention study that assessed distribution of IPT to pregnant women by TBAs, CRHWs, APMs and DSVs compared with health units. Pregnant women of all parities were enrolled. Key resource persons in each parish were identified to sensitise the communities on the intervention. Data was collected regarding: timing of the first dose of SP, proportion of women who complete two doses of SP, birth weight of babies, proportion of low birth-weight babies, and proportion of adolescent pregnancies. The third phase of the study evaluated the sustainability of the approaches.
Work Plan: The first phase of the study took two months. The second phase took 14-16 months. Data analysis was expected to take 12 months.
Condition | Intervention |
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Malaria Pregnancy Anemia |
Drug: sulphadoxine-pyrimethamine intermittent preventive treatment |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A New Approach to Deliver Malaria Preventions to Pregnant Women at a Community Level in Uganda |
Estimated Enrollment: | 2150 |
Study Start Date: | May 2003 |
Study Completion Date: | June 2007 |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Uganda, Central Uganda | |
Mukono District | |
Mukono, Central Uganda, Uganda, P.O Box 7272 |
Principal Investigator: | Anthony K Mbonye, MpH | Ministry of Health, Uganda |
Study ID Numbers: | MV-713-624-02-0033 |
Study First Received: | June 30, 2005 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00118027 History of Changes |
Health Authority: | Uganda: National Council for Science and Technology |
Malaria in pregnancy Anaemia Low birth weight |
Birth Weight Pyrimethamine Protozoan Infections Anti-Infective Agents Sulfadoxine-pyrimethamine Hematologic Diseases Anemia Folate Anti-Infective Agents, Urinary |
Malaria Folinic Acid Folic Acid Antagonists Sulfadoxine Vitamin B9 Body Weight Folic Acid Antimalarials Parasitic Diseases |
Pyrimethamine Protozoan Infections Anti-Infective Agents Sulfadoxine-pyrimethamine Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Hematologic Diseases Coccidiosis Anemia Anti-Infective Agents, Urinary |
Enzyme Inhibitors Malaria Renal Agents Folic Acid Antagonists Sulfadoxine Pharmacologic Actions Antimalarials Antiparasitic Agents Therapeutic Uses Parasitic Diseases |