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
试验速览
- 阶段
- 不适用
- 入组人数
- 1,028
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
We aim to evaluate whether IPT in pregnancy provides any additional benefit to the protection afforded by ITNs.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Less than 28 weeks of pregnancy
排除标准
- •Previous allergic reactions to sulphonamides
结局指标
主要结局
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
次要结局
- 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