MedTrace Logo

Preventing Malaria During Pregnancy in Epidemic-prone Areas.

NCT00142207 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4775

Last updated 2017-01-12

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy and cost-effectiveness of three alternative strategies for the prevention of malaria during pregnancy in an epidemic-prone area of low transmission in the East African Highlands.

The strategies being compared are:

* intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP)
* an insecticide treated net (ITN), and
* intermittent preventive treatment with SP plus an ITN

In addition to the main individually-randomised trial, outcome data was subsequently also gathered on pregnant women whose houses where sprayed with indoor residual insecticides (IRS) as part of a non-randomised district-wide control programme to compare the impact of IRS with the three intervention arms.

Conditions

  • Malaria, Falciparum

Interventions

DRUG

Intermittent preventive treatment:sulphadoxine-pyrimethamine

Two doses given twice during pregnancy (once in the second trimester, and once in the third trimester). Oral medication in tablet form: single daily dose given on each occasion

DEVICE

Insecticide-treated mosquito bed net

Insecticide-treated mosquito bed net

Sponsors & Collaborators

  • Ministry of Health, Uganda

    collaborator OTHER_GOV

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Richard H Ndyomugyenyi, MBChB, PhD · Vector Control Division, Ministry of Health, Uganda

  • Sian E Clarke, PhD · London School of Hygiene and Tropical Medicine, University of London, UK

  • Pascal Magnussen, MD · DBL - Institute for Health Research and Development, Denmark

  • Kristian Schultz Hansen, PhD · DBL - Institute for Health Research and Development, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2007-01-31
Completion
2007-01-31

Countries

  • Uganda

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00142207 on ClinicalTrials.gov