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Efficacy of
sulphadoxine-pyrimethamine and amodiaquine alone or in combination as
intermittent preventive treatment in pregnancy in the Kassena-Nankana district
of Ghana: a randomized controlled study.
Principal Investigator
: Dr. Christine
Clerk
Collaborating
Institution(s):
London School of Hygiene and Tropical Medicine
Funding
: Gates Malaria
Partnership
Project Summary
In areas of stable
transmission, pregnant women are more likely than non-pregnant women to become
infected with Plasmodium falciparum malaria and this is especially so
during first and second pregnancies.
Infections in pregnant
women are often asymptomatic, and the main effect of maternal malaria in
moderate to high transmission areas is anaemia, which is often severe and low
birth-weight. The prevalence of malaria infection in pregnancy in endemic areas
is estimated to be between 10-65% with substantial population attributable risks
(PAR) for poor outcomes of pregnancy. Malaria is associated with 3-16% of cases
of anaemia, 8-36% of low birth weight, 13-70% of intrauterine growth
retardation-low birth weight, and 3-8% of infant mortality.
Until recently, WHO
recommended that pregnant women living in malaria endemic areas should be given
chemoprophylaxis throughout pregnancy. The effectiveness of this strategy has
been limited by the spread of resistance to chloroquine, poor compliance with
routine chemoprophylaxis, and logistical and economic restraints. The use of
insecticide treated bed nets has not been effective in all transmission
settings. Following favorable results from the use of sulphadoxine-pyrimethamine
as intermittent preventive treatment, WHO now recommends that intermittent
treatment with an effective, preferably one-dose anti-malarial drug delivered in
the context of antenatal care should be made available to primi- and
secundigravidae as an appropriate and effective method for reducing the
consequences of malaria in highly endemic areas.
Intermittent preventive
treatments with sulphadoxine-pyrimethamine have reduced the incidence of anaemia
and low birth weight. However information on the efficacy of this intervention
has come mainly from Malawi and Kenya. Furthermore, resistance to
sulphadoxine-pyrimethamine is spreading, threatening its efficacy for
intermittent preventive treatment and there is an urgent need to identify
alternative safe, affordable and effective antimalarials that could replace it
for use as intermittent preventive treatment in pregnancy.
In view of the poor
compliance associated with chloroquine prophylaxis and increasing resistance to
chloroquine, Ghana has reviewed its antimalarial policy and it is recommended
that intermittent preventive treatment with sulphadoxine-pyrimethamine be given
during pregnancy.
This study aims to assess
the efficacy of SP used as IPTp in an intense and highly seasonal
transmission setting, and in view of the intensifying resistance to SP, evaluate
the efficacy and safety of amodiaquine and a combination of amodiaquine and SP
as alternatives to SP in reducing maternal anaemia and low birth weight in
infants.
Ethics approval has been
obtained from
The NHRC-Institutional
Review Board, the Ghana Health Service Ethics Board and the London School of
Hygiene and Tropical Medicine Ethics Committee.
Person to whom correspondence should be addressed:
Dr. Christine A Clerk
Navrongo Health Research
Centre
Ministry of Health
PO Box 114
Navrongo, Ghana,
cclerk@navrongo.mimcom.net
Phone: +233 742 22310
Fax:
+233 742 22320
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