IPTp Plus ITNs for Malaria Control in Pregnant Women

Not Applicable

• Conditions: Pregnancy

• Registration Number: NCT00209781
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2006-12
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-29
• Last Update Posted: 2008-03-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1028

Inclusion Criteria

• Less than 28 weeks of pregnancy

Exclusion Criteria

• Previous allergic reactions to sulphonamides

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Centro de Investigaçao em Saude da Manhiça; 🇲🇿 Manhiça, Maputo, Mozambique