Establishing Effectiveness of Daily Co-trimoxazole Prophylaxis For Prevention of Malaria in Pregnancy
Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
Summary
Malaria is a major contributor of disease burden in Sub-Saharan Africa: 90% of global cases
occur there, and pregnant women and children under 5 years are the most vulnerable. Malaria
in pregnancy increases risks of abortion, stillbirth, prematurity, intrauterine growth
retardation and maternal anemia, and is associated with higher risk of low birth weight and
perinatal, neonatal and infant mortality. For prevention and control of malaria in pregnancy,
the WHO recommends Intermittent Preventive Treatment (IPT) with antimalarial drugs,
insecticide treated nets (ITNs) and effective treatment of malaria and anemia.
HIV in pregnancy increases the risks of malaria, and it seems that the efficacy of IPT with
the drug sulphadoxine-pyrimethamine (SP) is decreased in HIV+ pregnant women.
Malaria prevention in pregnancy in Zambia relies on ITNs and IPT with SP. Daily prophylaxis
with cotrimoxazole (CTX) effectively reduces mortality and morbidity in HIV+ individuals, and
antibiotic therapy during pregnancy might help to decrease adverse pregnancy outcomes. CTX
prophylaxis improves birth outcomes in HIV+ women with CD4<200/µl: a study concluded that
antenatal provision of CTX was beneficial for HIV+ pregnant women with low CD4 but not in
women with ≥200/µl (however, this study was carried out in an area with very low risk of
malaria , and CTX may have a different effect depending on endemic conditions). The WHO
recommends daily CTX in addition to ARVs, to prevent opportunistic infections in all HIV+
patients.
Concurrent administration of SP and CTX may increase the incidence of severe adverse
reactions in HIV+ patients, so WHO has promoted CTX prophylaxis as an alternative to SP for
the IPT in immuno-compromised pregnant women. Unfortunately, there is insufficient
information on the effectiveness of daily CTX for preventing malaria infection in pregnancy:
so, SP is still the only antimalarial recommended by WHO for this purpose. With the increase
in SP resistance and with the newer antimalarials still being studied for safety and efficacy
in pregnancy, CTX could be an alternative for SP in reducing malaria and malaria-related
morbidity and mortality in pregnancy.
This study will try to to see if in HIV- and HIV+ pregnant women, CTX is not inferior to SP
in reducing placental parasitaemia. Such information is needed to issue updated, effective
guidelines on malaria prevention in pregnancy