IPT of Malaria With SP in Different Zones of Drug Resistance in Rwanda
|Non HIV Infected Pregnant Women||Drug: Sulfadoxine-Pyrimethamine Drug: placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in Different Zones of Drug Resistance in 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 ]
|Study Start Date:||December 2005|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
|Placebo Comparator: placebo||
The control group receives placebo similar in taste and appearance to to the experimental arm
The intervention group receives 1500mg of sulfadoxine and 75mg of pyrimethamine at enrollment and in the third trimester.
Other Name: fansidar
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372632
|Programme Nationale de Controle de Paludisms|
|Study Director:||Umberto D'Alessandro, MD,MSc, PHD||Institute of Tropical Medicine, Antwerp|