NCT00372632|CompletedPhase 4
IPT of Malaria With SP in Different Zones of Drug Resistance in Rwanda
Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in Different Zones of Drug Resistance in Rwanda
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Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in Different Zones of Drug Resistance in Rwanda
Sponsor study identifier
interventional
1,717
1 country
1
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2008
Actual (reported)Study Completion
April 2008
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 5, 2006
Actual (reported)September 7, 2006
Actual (reported)April 2008
Actual (reported)April 2008
Actual (reported)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
maternal placental blood at delivery; maternal peripheral blood at monthly visits between 16 weeks of gestation and delivery
LBW = birth weight <2,500 grams
at delivery
Premature delivery = delivery prior to 37 weeks gestation
at delivery
Spontaneous miscarriage = any spontaneous abortion before the end of gestation
at delivery
Stillbirth
at delivery
Cord blood parasitaemia = presence of asexual stage parasites in thick smears
at delivery
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
Umberto D'Alessandro, MD,MSc, PHD
Institute of Tropical Medicine Antwerp
1,717 participants (actual enrollment reported by the registry).
First Submitted
September 5, 2006
First Posted
September 7, 2006
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
April 2008
Actual (reported)Study Completion
April 2008
Actual (reported)Last Updated
September 14, 2010
Record last verified: 2010-09
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Source: ClinicalTrials.gov.
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