Non HIV Infected Pregnant Women Clinical Trial
Official title:
Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in Different Zones of Drug Resistance in Rwanda
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
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.
This will be a randomized blinded placebo controlled trial: women in the 16-28th week of
gestation will be offered enrolment into the study and randomized to receive IPT/SP regimen
or placebo once during the second and once in the third trimesters.
The study will be conducted in Mashesha (estimated SP drug resistance 20%, 12% in 2000),
Kicukiro (40% SP resistance) and Rukara (60% SP resistance). In each of these sites there
are about 1000 deliveries per year. According to DHMT data, over 75% of pregnant women
attend antenatal clinics, usually booking between 15 and 25 weeks of gestation. Based on
this study we expect to find placental malaria prevalence over 50% in all sites.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment