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IPTp Plus ITNs for Malaria Control in Pregnant Women
This study is ongoing, but not recruiting participants.
Study NCT00209781   Information provided by Hospital Clinic of Barcelona
First Received: September 13, 2005   Last Updated: February 29, 2008   History of Changes

September 13, 2005
February 29, 2008
August 2003
 
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
Evaluate whether two doses of intermittent treatment with SP delivered through antenatal clinics provides additional benefit to the protection afforded by ITNs on severe maternal anaemia at delivery
Complete list of historical versions of study NCT00209781 on ClinicalTrials.gov Archive Site
  • 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
  • · To assess whether intermittent treatment with sulfadoxine-pyrimethamine provides any additional benefit to the protection afforded by ITNs on the:
  • i) Maternal anaemia at and after delivery
  • ii) Parasite prevalence at and after delivery
  • iii) Placental malaria infection
  • iv) Proportion of low birth weight babies
  • v) Gestational age of the newborn
  • vi) 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
 
IPTp Plus ITNs for Malaria Control in Pregnant Women
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

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

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.

 
Interventional
Allocation:  Randomized
Control:  Placebo Control
Intervention Model:  Parallel Assignment
Masking:  Double-Blind
Primary Purpose:  Diagnostic
Pregnancy
  • Drug: Sulfadoxine-Pyrimethamine (Fansidar)
  • Device: ITNs
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
1028
December 2006
 

Inclusion Criteria:

  • Less than 28 weeks of pregnancy

Exclusion Criteria:

  • Previous allergic reactions to sulphonamides
Female
 
Yes
Contact information is only displayed when the study is recruiting subjects
Mozambique
 
NCT00209781
 
TimNet
Hospital Clinic of Barcelona
 
Principal Investigator: Clara Menendez, MD, PhD Centre for International Health, Hospital Clinic de Barcelona
Hospital Clinic of Barcelona
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP