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NCT00209781 Clinical Trial

IPTp Plus ITNs for Malaria Control in Pregnant Women

Pregnancy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00209781
Other study ID # TimNet
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 13, 2005
Last updated February 29, 2008
Start date August 2003
Est. completion date December 2006

Study information
Verified date February 2008
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority Mozambique: Ministry of Health (MISAU)
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1028
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Less than 28 weeks of pregnancy

Exclusion Criteria:

- Previous allergic reactions to sulphonamides

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Sulfadoxine-Pyrimethamine (Fansidar)

Device:
• ITNs

Locations
Country Name City State
Mozambique Centro de Investigaçao em Saude da Manhiça Manhiça Maputo

Sponsors (1)
Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Mozambique, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 To assess whether intermittent treatment with sulfadoxine-pyrimethamine provides any additional benefit to the protection afforded by ITNs on the:
Secondary Maternal anaemia at and after delivery
Secondary Parasite prevalence at and after delivery
Secondary Placental malaria infection
Secondary Infant mortality and morbidity
Secondary Gestational age of the newborn
Secondary Child parasitaemia and anaemia 12 months after delivery
Secondary To identify the operational and socio-cultural issues involved in the delivery to and use of ITNs by pregnant women
Secondary To evaluate the cost-effectiveness of the interventions
Secondary To determine the duration of the efficacy of long-lasting insecticide-treated nets against Anopheles mosquitoes
Secondary To assess the immunological protection against malaria in children during the first year of life regarding malaria preventive interventions in their mothers during pregnancy
Secondary 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
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