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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,717
The intervention group receives 1500mg of sulfadoxine and 75mg of pyrimethamine at enrollment and in the third trimester.
The control group receives placebo similar in taste and appearance to to the experimental arm
Programme Nationale de Controle de Paludisms
Kigali, Rwanda
malaria infection will be defined as the presence of asexual stage parasites on thick smears made with maternal side placental blood and Maternal peripheral blood
Time frame: maternal placental blood at delivery; maternal peripheral blood at monthly visits between 16 weeks of gestation and delivery
LBW = birth weight <2,500 grams
Time frame: at delivery
Premature delivery = delivery prior to 37 weeks gestation
Time frame: at delivery
Spontaneous miscarriage = any spontaneous abortion before the end of gestation
Time frame: at delivery
Stillbirth
Time frame: at delivery
Cord blood parasitaemia = presence of asexual stage parasites in thick smears
Time frame: at delivery
Neonatal death = infant death within the first 28 days of life
Time frame: 7days and 6 weeks after delivery
Maternal anemia = Hb <11.0 g/dL
Time frame: at monthly visits between 16 weeks of gestation and delivery
Maternal severe anemia = Hb <6 g/dL
Time frame: at monthly visits between 16 weeks of gestation and delivery
Symptomatic maternal malaria infection = axillary temperature 37.5°C and asexual parasitaemia
Time frame: at monthly visits between 16 weeks of gestation and delivery
Severe maternal adverse reactions to SP = severe cutaneous reactions (e.g., erythema multiform, Stevens-Johnson syndrome, or toxic epidermal necrolysis)
Time frame: at monthly visits between 16 weeks of gestation and delivery plus at day 7 and week 6 after delivery
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