NCT00209781

IPTp Plus ITNs for Malaria Control in Pregnant Women

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,028 (planned)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DRUG	Sulfadoxine-Pyrimethamine (Fansidar)
DEVICE	ITNs

Timeline

• Start date: 2003-08-01
• Completion: 2006-12-01
• First posted: 2005-09-21
• Last updated: 2008-03-06

Locations

1 site across 1 country: Mozambique