Overview

This trial is active, not recruiting.

Condition pregnancy
Treatments sulfadoxine-pyrimethamine (fansidar), itns
Sponsor Hospital Clinic of Barcelona
Start date August 2003
End date December 2006
Trial size 1028 participants
Trial identifier NCT00209781, TimNet

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double-blind
Primary purpose diagnostic

Primary Outcomes

Measure
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
time frame:

Secondary Outcomes

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

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - Less than 28 weeks of pregnancy Exclusion Criteria: - Previous allergic reactions to sulphonamides

Additional Information

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
Principal investigator Clara Menendez, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2008.
Information provided to ClinicalTrials.gov by Hospital Clinic of Barcelona.