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IPTp Plus ITNs for Malaria Control in Pregnant Women

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ClinicalTrials.gov Identifier: NCT00209781
Recruitment Status : Unknown
Verified February 2008 by Hospital Clinic of Barcelona.
Recruitment status was:  Active, not recruiting
First Posted : September 21, 2005
Last Update Posted : March 6, 2008
Information provided by:
Hospital Clinic of Barcelona

Brief Summary:
We aim to evaluate whether IPT in pregnancy provides any additional benefit to the protection afforded by ITNs.

Condition or disease Intervention/treatment
Pregnancy Drug: Sulfadoxine-Pyrimethamine (Fansidar) Device: ITNs

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1028 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
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
Study Start Date : August 2003
Estimated Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Primary Outcome Measures :
  1. Evaluate whether two doses of intermittent treatment with SP delivered through antenatal clinics provides additional benefit to the protection afforded by ITNs on low birth weight

Secondary Outcome Measures :
  1. To assess whether intermittent treatment with sulfadoxine-pyrimethamine provides any additional benefit to the protection afforded by ITNs on the:
  2. Maternal anaemia at and after delivery
  3. Parasite prevalence at and after delivery
  4. Placental malaria infection
  5. Infant mortality and morbidity
  6. Gestational age of the newborn
  7. Child parasitaemia and anaemia 12 months after delivery
  8. To identify the operational and socio-cultural issues involved in the delivery to and use of ITNs by pregnant women
  9. To evaluate the cost-effectiveness of the interventions
  10. To determine the duration of the efficacy of long-lasting insecticide-treated nets against Anopheles mosquitoes
  11. To assess the immunological protection against malaria in children during the first year of life regarding malaria preventive interventions in their mothers during pregnancy
  12. To asses the effect of IPT with SP in HIV positive pregnant women on the prevention of mother-to-child HIV transmission and on the viral load reduction in the mother

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Less than 28 weeks of pregnancy

Exclusion Criteria:

  • Previous allergic reactions to sulphonamides

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209781

Centro de Investigaçao em Saude da Manhiça
Manhiça, Maputo, Mozambique
Sponsors and Collaborators
Hospital Clinic of Barcelona
Principal Investigator: Clara Menendez, MD, PhD Centre for International Health, Hospital Clinic de Barcelona

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00209781     History of Changes
Other Study ID Numbers: TimNet
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 6, 2008
Last Verified: February 2008

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Fanasil, pyrimethamine drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents