Intermittent Preventive Treatment Versus Scheduled Screening and Treatment of Malaria in Pregnancy
Condition: Malaria; Pregnancy; Anaemia
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): Intermittent screening and treatment of malaria in pregnancy (IST); SP-IPTp
Intervention type(s): Drug; Drug
Intervention description(s): Scheduled intermittent screening of study women using rapid diagnostic test and treatment of those who are RDT positive during ante-natal clinic visits in the 2nd and 3rd trimester with arthemether lumefantrine.; Study women will receive at least two doses of Sulfadoxine Pyrimethamine during their pregnancy, one at each of the recommended ante-natal visits during the 2nd and 3rd trimester.
Other intervention name(s): Coartem; SP
Intervention MeSH terms: Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Low birth weight; Placenta malaria; Anaemia; Intermittent preventive treatment; Intermittent screening and treatment; Rapid diagnostic test