IPT of Malaria With SP in Different Zones of Drug Resistance in Rwanda

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The present study will address the question whether the use of IPT using SP in pregnancy is efficacious in Rwanda, where it is going to be used for the first time, in areas with high levels of SP resistance. While the implementation of the new policy will take place in areas at low SP resistance level, where we expect pregnant women and newborns to benefit from it, it is of paramount importance to clarify which is the real impact of IPT/SPin areas of high SP drug resistance and at what level of SP resistance this strategy is still efficacious. As bed nets are a part of the actual control strategy of malaria in pregnancy all women will receive a bed net at enrolment

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institute of Tropical Medicine, Belgium
• Treatments: Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

1. Pregnant women between 16-28 weeks of gestation;

2. Residence within the catchment's area of the health facility;

3. Willing to deliver at the health facility;

4. Willing to ; adhere to all requirements of the study;

5. Willing to provide written informed consent;

6. Aged 21 years and above

Exclusion Criteria:

1. Severe anemia (Hb < 6 g/dL)

2. History of allergic reactions to sulfa drugs;

3. Taking other sulfa drugs as CTX;

4. History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section);

5. History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis, prior to randomization;

6. Any significant illness that requires hospitalization;

7. Intent to move out of the study catchment's area before delivery or deliver at relative's home out of the catchment's area;

8. Prior enrollment in the study or concurrent enrollment in another study