A randomized placebo-controlled trial of intermittent preventive treatment in pregnant women in the context of insecticide treated nets delivered through the antenatal clinic.
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.
Menéndez
Clara
C
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
Bardají
Azucena
A
Sigauque
Betuel
B
Romagosa
Cleofé
C
Sanz
Sergi
S
Serra-Casas
Elisa
E
Macete
Eusebio
E
Berenguera
Anna
A
David
Catarina
C
Dobaño
Carlota
C
Naniche
Denise
D
Mayor
Alfredo
A
Ordi
Jaume
J
Mandomando
Inacio
I
Aponte
John J
JJ
Mabunda
Samuel
S
Alonso
Pedro L
PL
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
D007306:Insecticides; D010919:Placebos; D013413:Sulfadoxine; D011739:Pyrimethamine