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Randomized Controlled Trial
. 2008 Apr 9;3(4):e1934.
doi: 10.1371/journal.pone.0001934.

A randomized placebo-controlled trial of intermittent preventive treatment in pregnant women in the context of insecticide treated nets delivered through the antenatal clinic

Clara Menéndez  1 , Azucena Bardají, Betuel Sigauque, Cleofé Romagosa, Sergi Sanz, Elisa Serra-Casas, Eusebio Macete, Anna Berenguera, Catarina David, Carlota Dobaño, Denise Naniche, Alfredo Mayor, Jaume Ordi, Inacio Mandomando, John J Aponte, Samuel Mabunda, Pedro L Alonso
Affiliations
Randomized Controlled Trial

A randomized placebo-controlled trial of intermittent preventive treatment in pregnant women in the context of insecticide treated nets delivered through the antenatal clinic

Clara Menéndez et al. PLoS One. .

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.

Findings: 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.

Trial registration: ClinicalTrials.gov NCT00209781.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. Trial profile
There were 3 and 7 twins births in the SP and placebo groups respectively. There was one triplet birth in the SP Group.* sulphadoxine-pyrimethamine ** 1 woman in the SP group and 2 in the placebo group had a miscarriage before receiving dose 1
Figure 2
Figure 2. Intention to treat cohort.
First or only episode of clinical malaria from IPTp dose 1 until delivery
See this image and copyright information in PMC

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