Intermittent Preventive Treatment Versus Scheduled Screening and Treatment of Malaria in Pregnancy
Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
Summary
The incidence of malaria, including the incidence in pregnant women, is declining in many
African countries. Thus, there is a need to re-examine the efficacy and cost effectiveness of
giving intermittent preventive treatment with sulphadoxine-pyrimethamine in pregnancy
(SP-IPTp) on several occasions during pregnancy, an intervention that is threatened by
increasing resistance to SP. Possible alternatives to SP-IPTp need to be explored. This
applies especially to areas with highly seasonal malaria transmission where women are at risk
for only a short period of the year.
The goal of this project is to determine whether in pregnant women who sleep under a long
lasting insecticide treated bed net, screening and treatment at each scheduled antenatal
clinic visit is as effective in protecting them from anaemia, low birth weight and placental
infection as SP-IPTp.
Primigravidae and secundigravidae who present at antenatal clinics in study sites in four
West African countries (Burkina Faso, Ghana, Mali and The Gambia) will be randomised to one
of two groups. All women will be given a long lasting insecticide treated bed net on first
presentation at the antenatal clinic. Women in group 1 (reference group) will receive SP-IPTp
according to the current WHO guidelines. Those in group 2 will be screened with a rapid
diagnostic test at each scheduled antenatal clinic visit and treated if parasitaemic.
Approximately 5000 women will be recruited, 2500 in each group. Women will be encouraged to
deliver in hospital where maternal haemoglobin and birth weight will be recorded and a
placental sample obtained. Those who deliver at home will be visited within a week of
delivery and maternal haemoglobin and infant weight recorded. Mothers and infants will be
seen again six weeks after delivery. Also at delivery peripheral maternal blood sample will
be obtained for the diagnosis of malaria using RDT, microscopy and PCR. The primary end
points of the trial will be birth weight and anaemia at 38 weeks (+/-2 weeks) of gestation.
The study is powered to show non-inferiority of group 2 compared to group 1. The costs and
cost effectiveness of each intervention will be evaluated.
In the light of recent evidence suggesting that malaria infection during pregnancy,
particularly in the last trimester may influence an infant's risk of malaria, we proposed to
follow infants born to mothers recruited in the Navrongo site in Ghana who have received
either IST or IPTp in pregnancy throughout the whole of their first year of life beyond the
six weeks originally proposed. We have received approval for this from the ethic committees
at Kwame Nkrumah University of Science and Technology, Ghana Health Service and Navrongo
Health Research Centre. The aim is to obtain information on the incidence of both symptomatic
and asymptomatic malaria infections in these infants during follow up of the infants.
The study will provide information to national malaria control programmes on whether there
are alternative, safe and effective methods to the SP IPTp regimen for reducing the burden of
malaria in pregnancy.
Phase:
Phase 4
Details
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborators:
Liverpool School of Tropical Medicine Medical Research and Training Centre, Mali Medical Research Council Unit, The Gambia Navrongo Health Research Centre, Ghana University of Ouagadougou, Burkina Faso
Treatments:
Artemether, Lumefantrine Drug Combination Fanasil, pyrimethamine drug combination Pyrimethamine Sulfadoxine