title: A randomized placebo-controlled trial of intermittent preventive treatment in pregnant women in the context of insecticide treated nets delivered through the antenatal clinic.
abstract: BACKGROUND
  Current recommendations to prevent malaria in African pregnant women rely on insecticide treated nets (ITNs) and intermittent preventive treatment (IPTp). However, there is no information on the safety and efficacy of their combined use.
  
  
  METHODS
  1030 pregnant Mozambican women of all gravidities received a long-lasting ITN during antenatal clinic (ANC) visits and, irrespective of HIV status, were enrolled in a randomised, double blind, placebo-controlled trial, to assess the safety and efficacy of 2-dose sulphadoxine-pyrimethamine (SP). The main outcome was the reduction in low birth weight.
  
  
  RESULTS
  Two-dose SP was safe and well tolerated, but was not associated with reductions in anaemia prevalence at delivery (RR, 0.92 [95% CI, 0.79-1.08]), low birth weight (RR, 0.99 [95% CI, 0.70-1.39]), or overall placental infection (p = 0.964). However, the SP group showed a 40% reduction (95% CI, 7.40-61.20]; p = 0.020) in the incidence of clinical malaria during pregnancy, and reductions in the prevalence of peripheral parasitaemia (7.10% vs 15.15%) (p<0.001), and of actively infected placentas (7.04% vs 13.60%) (p = 0.002). There was a reduction in severe anaemia at delivery of borderline statistical significance (p = 0.055). These effects were not modified by gravidity or HIV status. Reported ITN's use was more than 90% in both groups.
  
  
  CONCLUSIONS
  Two-dose SP was associated with a reduction in some indicators, but these were not translated to significant improvement in other maternal or birth outcomes. The use of ITNs during pregnancy may reduce the need to administer IPTp. ITNs should be part of the ANC package in sub-Saharan Africa.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00209781.
authors.affiliation: Barcelona Center for International Health Research (CRESIB) and Department of Pathology Hospital Clinic, Institut d'Investigacions Biomedicas August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain. menendez@clinic.ub.es
authors.forename: Clara
authors.initials: C
authors.lastname: Menéndez
authors.forename: Azucena
authors.initials: A
authors.lastname: Bardají
authors.forename: Betuel
authors.initials: B
authors.lastname: Sigauque
authors.forename: Cleofé
authors.initials: C
authors.lastname: Romagosa
authors.forename: Sergi
authors.initials: S
authors.lastname: Sanz
authors.forename: Elisa
authors.initials: E
authors.lastname: Serra-Casas
authors.forename: Eusebio
authors.initials: E
authors.lastname: Macete
authors.forename: Anna
authors.initials: A
authors.lastname: Berenguera
authors.forename: Catarina
authors.initials: C
authors.lastname: David
authors.forename: Carlota
authors.initials: C
authors.lastname: Dobaño
authors.forename: Denise
authors.initials: D
authors.lastname: Naniche
authors.forename: Alfredo
authors.initials: A
authors.lastname: Mayor
authors.forename: Jaume
authors.initials: J
authors.lastname: Ordi
authors.forename: Inacio
authors.initials: I
authors.lastname: Mandomando
authors.forename: John J
authors.initials: JJ
authors.lastname: Aponte
authors.forename: Samuel
authors.initials: S
authors.lastname: Mabunda
authors.forename: Pedro L
authors.initials: PL
authors.lastname: Alonso
mesh_terms: D000293:Adolescent; D000328:Adult; D000349:Africa; D001512:Bedding and Linens; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007306:Insecticides / Q000494:pharmacology*; D008288:Malaria / Q000517:prevention & control*; D010919:Placebos; D011247:Pregnancy; D015597:Pregnancy Complications, Parasitic / Q000517:prevention & control; D011739:Pyrimethamine / Q000008:administration & dosage; D013413:Sulfadoxine / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D007306:Insecticides; D010919:Placebos; D013413:Sulfadoxine; D011739:Pyrimethamine