Status:
COMPLETED
Preventing Malaria During Pregnancy in Epidemic-prone Areas.
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Ministry of Health, Uganda
Conditions:
Malaria, Falciparum
Eligibility:
FEMALE
Phase:
PHASE3
Brief 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...
Detailed Description
Susceptibility to malaria infection during pregnancy and the severity of clinical manifestation are determined by the level of pre-pregnancy immunity, which depends on intensity and stability of malar...
Eligibility Criteria
Inclusion
- Pregnant women whose pregnancies are at \<27 weeks gestation at first antenatal booking
- Permanent resident in study area
- Informed consent
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
4775 Patients enrolled
Trial Details
Trial ID
NCT00142207
Start Date
January 1 2004
End Date
January 1 2007
Last Update
January 12 2017
Active Locations (1)
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1
Kabale District Health Services (antenatal clinics at selected sites)
Kabale, Kabale District, Uganda