Malaria in Pregnancy Clinical Trial
Official title:
New Approaches to Improve Coverage and Compliance of Antimalarial Treatment for Pregnant Women in Rural Africa.
Malaria in pregnancy contributes substantially to maternal anaemia and low birth weight:
effective malaria control in pregnancy could avoid about 10,000 maternal and up to 200,000
infant deaths every year. Intermittent preventive treatment with the drug
sulfadoxine-pyrimethamine (IPTp-SP), administered at least twice during routine antenatal
clinics, is recommended by the World Health Organization for areas of moderate to high
malaria transmission, including Sub-Saharan Africa.
Studies carried out in Kenya and Malawi before 2004 had showed that two doses of IPTp-SP
significantly reduce maternal anaemia, placental malaria parasitaemia and low birth weight.
However, in countries where this strategy had been introduced as part of national policy,
the coverage of the target population has varied widely, with estimates of 33-93% for uptake
of one dose and 24-68% for two doses, and no country had reached the goal of 80% of pregnant
women receiving at least 2 doses of IPTp. New approaches designed to improve IPTp coverage
were therefore urgently needed.
This study was therefore set up in 2002, in order to evaluate the additional effect of a
targeted promotional campaign on antenatal clinics utilization and on coverage and uptake of
Intermittent preventive treatment with sulfadoxine-pyrimethamine in a rural health district
in Burkina Faso; and to investigate the effectiveness of intermittent preventive treatment
with the sulfadoxine-pyrimethamine compared with weekly chloroquine, in order to provide
additional evidence to the Burkinabé Ministry of Health for an impending policy change.
Each year, about 50 million women living in malaria endemic regions become pregnant, more
than half in sub-Saharan Africa. In areas of relatively stable transmission, where acquired
immunity to Plasmodium falciparum limits infection and prevents severe disease in adults,
women in their first and second pregnancy are the most vulnerable subjects, due to a higher
risk of severe anaemia and a low birth weight (LBW) outcome, a leading cause of child
mortality and poor growth and development.
Malaria in pregnancy and its adverse consequences can be prevented with suppressive
antimalarial treatment or chemoprophylaxis. Weekly chloroquine (CQ) had been the basis for
prevention for many years, but its application became limited over time, partly because of
difficulties in coverage and compliance throughout pregnancy and partly because of increased
parasite resistance to CQ in endemic areas. A new strategy for prevention based on
insecticide-treated bed nets (ITNs) and use of intermittent preventive treatment in
pregnancy (IPTp) was thus formulated, with IPTp being based on the administration of
treatment doses of sulfadoxine-pyrimethamine (1500/75 mg; SP) to all pregnant women at
pre-defined intervals and regardless of malaria infection. WHO elaborated new
recommendations, based on the administration of SP two or three times at scheduled antenatal
visits at least one month apart from the second trimester onwards. Evidence of the efficacy
of IPTp with SP for preventing malaria infection and improving birth weight was reported
from East Africa and West Africa.
However, the IPTp strategy assumes that most pregnant women attend antenatal clinics (ANC)
at least twice during their pregnancy and at a time when SP can be administered under direct
observation. Unfortunately, it appeared soon that late attendance to ANC and weak health
services limit the effectiveness of this strategy; coverage with two or more SP doses varied
widely (24-68%) and was well behind the goal of 80% proposed by the Roll Back Malaria
Partnership. New approaches to increase IPTp coverage were urgently needed.
This study, conceived in 2002 and carried out between 2004 and 2006, had therefore two
different components: on one side, it investigated whether promoting regular and early
antenatal attendance of pregnant women through community based health education would
increase coverage and uptake of IPTp; on the other side, it investigated the effectiveness
of IPTp-SP compared with weekly CQ, in order to provide additional evidence to the Burkinabé
Ministry of Health for an impending policy change.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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