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| Sponsor: | Hospital Clinic of Barcelona |
|---|---|
| Information provided by: | Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT00209781 |
Purpose
We aim to evaluate whether IPT in pregnancy provides any additional benefit to the protection afforded by ITNs.
| Condition | Intervention |
|---|---|
|
Pregnancy |
Drug: Sulfadoxine-Pyrimethamine (Fansidar) Device: ITNs |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
| Official Title: | Effect of Intermittent Preventive Treatment (IPTp) With Sulfadoxine-Pyrimethamine Plus Insecticide Treated Nets, Delivered Through Antenatal Clinics for the Prevention of Malaria in Mozambican Pregnant Women |
| Estimated Enrollment: | 1028 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | December 2006 |
Pregnant women are at an increased risk for malaria infection and disease. Maternal anaemia, low birth weight and prematurity are the most frequent adverse effects of the infection. The current WHO recommendation consists on the provision of insecticide treated nets (ITN's) and intermittent preventive treatment (IPT). Results from a recentn trial of ITN's have shown a significant reduction in maternal anaemia, parasitaemia and low birth weight prevalence in women sleeping under impregnated nets. However, scarce information exists on the relative efficacy of IPT and ITNs to reduce the deleterious effects of malaria infection during pregnancy when given at the same time. This information is of relevance to guide national malaria control programmes.
This study consists on the administration of two double blind doses of IPT with Sulfadoxine-Pyrimethamine or placebo at predefined intervals, after the beginning of the second trimester. All women receive an ITN.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Mozambique, Maputo | |
| Centro de Investigaçao em Saude da Manhiça | |
| Manhiça, Maputo, Mozambique | |
| Principal Investigator: | Clara Menendez, MD, PhD | Centre for International Health, Hospital Clinic de Barcelona |
More Information
| Study ID Numbers: | TimNet |
| Study First Received: | September 13, 2005 |
| Last Updated: | February 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00209781 History of Changes |
| Health Authority: | Mozambique: Ministry of Health (MISAU) |
|
Pyrimethamine Anti-Infective Agents Sulfadoxine-pyrimethamine Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Anti-Infective Agents, Urinary |
Renal Agents Sulfadoxine Folic Acid Antagonists Pharmacologic Actions Antimalarials Antiparasitic Agents Therapeutic Uses |