Malaria in Pregnancy Clinical Trial
Official title:
Assessment of the Efficacy and Effectiveness of Sulphadoxine-pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Malawi
The purpose of this study is to determine the efficacy and effectiveness of sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy for reducing malaria-associated morbidity in pregnant women in Malawi.
Malaria infection in pregnancy is associated with severe maternal anemia, placental
parasitemia, low birth weight, and increased perinatal mortality. Intermittent preventive
treatment in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) is recommended by the
World Health Organization (WHO) for reducing the risks associated with malaria in pregnancy.
Traditionally, the level of SP resistance has been assessed by monitoring its in vivo
efficacy for treatment of uncomplicated malaria in children under five years of age.
However, parasite resistance to SP has compromised its efficacy in young children, and SP is
no the longer a first-line recommended treatment for malaria in most African countries.
Although SP currently appears to remain effective for IPTp in pregnant women probably
because they have more immunity than young children, it is important to monitor SP
effectiveness in this population. Characterizing SP resistance through in vivo and molecular
methods in pregnant women may be useful to predict whether to continue a policy of IPTp with
SP.
There will be three parts to this study. To determine therapeutic efficacy of SP IPTp in
pregnant women, a prospective in vivo study will be done in women who present for antenatal
care (ANC). Women will receive SP IPTp according to national guidelines and will be followed
for 42 days for clearance of peripheral parasitemia. To determine birth outcomes of women
given SP IPTp, a retrospective cohort study will be performed assessing outcomes of women at
delivery. Information on prior receipt of SP IPTp, peripheral and placental parasitemia at
delivery, placental histology, maternal anemia, and birth weight will be collected. To
characterize baseline resistance of SP in pregnant women and in the general population,
parasites will be collected from both participating women and attendees at outpatient
clinics to measure SP resistance markers.
The results of this study will be used by the Malawi national control program to evaluate
current policy of using SP for IPTp. This study will also contribute towards an
international effort led by WHO to align priorities and methodologies in gathering data on
the efficacy of SP in IPTp in the face of increasing SP resistance, thus providing data to
inform IPTp policy at the global level.
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Observational Model: Cohort
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