Malaria Clinical Trial
Official title:
Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine Versus Weekly Chloroquine Prophylaxis During Pregnancy in Solomon Islands: a Randomized Controlled Trial
The purpose of this study is to assess the effectiveness of intermittent preventive treatment in pregnancy (IPTp) with Sulphadoxine-pyrimethamine compared to chloroquine prophylaxis in Honiara, Solomon Islands for prevention of malaria and it's adverse effects in pregnancy.
Malaria is a major health problem in the Solomon Islands, with an annual estimated incidence
of 158 per 1000 population in 2005, and P. falciparum and P. vivax responsible for
respectively 71% and 29% of the clinical cases. Not much is known about the burden of
malaria in pregnancy and the effectiveness of weekly chloroquine prophylaxis, the national
policy for the prevention of malaria in pregnancy. In Honiara, the capital, 42.7% of the
pregnant women are anaemic at their first antenatal clinic (ANC) visit. In a national
data-base, clinical malaria in pregnancy was associated with an increased risk of anaemia.
High levels of chloroquine drug resistance have been reported (67% treatment failure at day
28 in 2001). Among women who attended an ANC in Honiara and had been offered chloroquine
prophylaxis, a high low birth weight risk among primigravidae compared to multigravidae was
noted. This information indicates that the current policy may not be optimal for the
prevention of malaria and its effects in pregnancy. Intermittent preventive treatment (IPTp)
with sulfadoxine-pyrimethamine (SP) in pregnancy is an alternative strategy which has been
introduced in many malarious countries in sub-Saharan Africa. Studies which compared IPTp
with chloroquine prophylaxis in Africa showed that IPTp was more beneficial. Resistance to
SP monotherapy in the Solomon islands has not been examined; however, the resistance to the
combination of SP and chloroquine is low (< 10%). IPTp with SP has so far not been
implemented in a region where P. vivax is common, and the effect of SP on P. vivax is not
clear.
We propose a randomized controlled trial to assess the effectiveness of IPTp with SP
compared to chloroquine prophylaxis in Honiara, the Solomon Islands. As outcome measures we
will examine the effect on anaemia in third trimester, placental malaria, maternal anaemia
at the time of delivery, infant birth weight, and prematurity. Outcomes in women allocated
IPTp with SP will be compared with those allocated chloroquine prophylaxis. We expect 2504
women from Honiara City Council to participate in the randomised controlled trial. To assess
the burden of malaria in pregnancy in other locations women we expect 1000 women to
participate in a survey at the time of delivery among women not participating in the trial.
At the end of this study, we will know the burden of malaria in pregnancy in Honiara and
Guadalcanal, and we will be able to assist in developing evidence based national guidelines
for malaria prevention among pregnant women in the Solomon Islands. The information obtained
will be important for other areas and countries with a similar epidemiology of malaria in
pregnancy.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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