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IPTp Plus ITNs for Malaria Control in Pregnant Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Hospital Clinic of Barcelona.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00209781
First received: September 13, 2005
Last updated: February 29, 2008
Last verified: February 2008
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • 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:
  • To assess whether intermittent treatment with sulfadoxine-pyrimethamine provides any additional benefit to the protection afforded by ITNs on the:
  • Maternal anaemia at and after delivery
  • Parasite prevalence at and after delivery
  • Placental malaria infection
  • Infant mortality and morbidity
  • Gestational age of the newborn
  • Child parasitaemia and anaemia 12 months after delivery
  • To identify the operational and socio-cultural issues involved in the delivery to and use of ITNs by pregnant women
  • To evaluate the cost-effectiveness of the interventions
  • To determine the duration of the efficacy of long-lasting insecticide-treated nets against Anopheles mosquitoes
  • To assess the immunological protection against malaria in children during the first year of life regarding malaria preventive interventions in their mothers during pregnancy
  • 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

Estimated Enrollment: 1028
Study Start Date: August 2003
Estimated Study Completion Date: December 2006
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Less than 28 weeks of pregnancy

Exclusion Criteria:

  • Previous allergic reactions to sulphonamides
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209781

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

Additional Information:
No publications provided by Hospital Clinic of Barcelona

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

ClinicalTrials.gov Identifier: NCT00209781     History of Changes
Other Study ID Numbers: TimNet
Study First Received: September 13, 2005
Last Updated: February 29, 2008
Health Authority: Mozambique: Ministry of Health (MISAU)

Additional relevant MeSH terms:
Fanasil, pyrimethamine drug combination
Pyrimethamine
Sulfadoxine
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014