Intermittent Preventative Treatment With Sulfadoxine-Pyrimethamine in Gambian Multigravidae
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Malaria is particularly harmful during pregnancy causing anemia in the mother and low birth weight which, in turn, increases infant mortality. Thus, the World Health Organization (WHO) now recommends that all pregnant women who live in malaria endemic areas of Africa should receive sulfadoxine-pyrimethamine (SP) at monthly intervals during the second and third trimesters of pregnancy. Malaria is especially severe during first pregnancies and the value of intermittent preventative treatment with SP during first pregnancies has been clearly shown. However, it is less certain whether multigravidae, who are at less risk, also benefit from intermittent preventative treatment with SP. To investigate this, a trial has been conducted in Gambian multigravidae who were given intermittent preventative treatment with SP or placebo during the second and third trimesters. The prevalence of anemia six weeks after delivery, low birth weight and poor outcome of pregnancy in women in each group were studied.
Condition | Intervention | Phase |
---|---|---|
Malaria |
Drug: Sulfadoxine-pyrimethamine |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Prevention |
Official Title: | A Randomised, Placebo Controlled Trial of Intermittent Preventative Treatment With Sulfadoxine-Pyrimethamine in Gambian Multigravidae. |
- Hemoglobin concentration at delivery.
- Birthweight.
- Hemoglobin concentration six weeks after delivery.
Estimated Enrollment: | 3000 |
Study Start Date: | July 2002 |
Estimated Study Completion Date: | September 2004 |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Multigravid pregnancy.
- Residence in study area.
- Informed consent.
Exclusion Criteria:
- Allergy to sulfonamides.
- Chronic illness.
Gambia | |
Medical Research Council Laboratories | |
Banjul, Gambia, PO Box 273 |
Study Chair: | Brian Greenwood, MD | London School of Hygiene and Tropical Medicine |
No publications provided
ClinicalTrials.gov Identifier: | NCT00120809 History of Changes |
Other Study ID Numbers: | ITCRVG27b |
Study First Received: | July 12, 2005 |
Last Updated: | July 18, 2005 |
Health Authority: | Gambia: Department of State for Health and Social Welfare |
Keywords provided by Gates Malaria Partnership:
Malaria Pregnancy Multigravidae Intermittent preventative treatment Sulfadoxine-pyrimethamine |
Additional relevant MeSH terms:
Malaria Protozoan Infections Parasitic Diseases Pyrimethamine Sulfadoxine Sulfadoxine-pyrimethamine Antimalarials Antiprotozoal Agents Antiparasitic Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |
ClinicalTrials.gov processed this record on October 16, 2012