IPTp Plus ITNs for Malaria Control in Pregnant Women

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

Detailed Description
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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.

Official Title
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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

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Sulfadoxine-Pyrimethamine (Fansidar)
* Device: ITNs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Less than 28 weeks of pregnancy Exclusion Criteria: Previous allergic reactions to sulphonamides
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sulfadoxine-Pyrimethamine (Fansidar)|nan|
|Device: ITNs|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |