Preventing Malaria During Pregnancy in Epidemic-prone Areas.

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gates Malaria Partnership; London School of Hygiene and Tropical Medicine
• Collaborator: Ministry of Health, Uganda
• Treatments: Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• Pregnant women whose pregnancies are at <27 weeks gestation at first antenatal booking

• Permanent resident in study area

• Informed consent

Exclusion Criteria:

• Late presentation: pregnancies more than 26 weeks gestation at first antenatal booking

• Severe anaemia (Hb<70g/L) on enrolment

• Previous reaction to a sulfa-drug (e.g. sulphadoxine-pyrimethamine, septrin)

• History of severe skin reaction to any drug

• Current (or history) of severe disease (e.g. hepatitis, jaundice, TB, AIDS)

Withdrawal Criteria:

• Withdrawal of consent

• Women developing severe anaemia (Hb<70g/L)during pregnancy