title: A Non-Inferiority, Individually Randomized Trial of Intermittent Screening and Treatment versus Intermittent Preventive Treatment in the Control of Malaria in Pregnancy.
abstract: BACKGROUND
  The efficacy of intermittent preventive treatment for malaria with sulfadoxine-pyrimethamine (IPTp-SP) in pregnancy is threatened in parts of Africa by the emergence and spread of resistance to SP. Intermittent screening with a rapid diagnostic test (RDT) and treatment of positive women (ISTp) is an alternative approach.
  
  
  RESULTS
  An open, individually randomized, non-inferiority trial of IPTp-SP versus ISTp was conducted in 5,354 primi- or secundigravidae in four West African countries with a low prevalence of resistance to SP (The Gambia, Mali, Burkina Faso and Ghana). Women in the IPTp-SP group received SP on two or three occasions whilst women in the ISTp group were screened two or three times with a RDT and treated if positive for malaria with artemether-lumefantrine (AL). ISTp-AL was non-inferior to IPTp-SP in preventing low birth weight (LBW), anemia and placental malaria, the primary trial endpoints. The prevalence of LBW was 15.1% and 15.6% in the IPTp-SP and ISTp-AL groups respectively (OR = 1.03 [95% CI: 0.88, 1.22]). The mean hemoglobin concentration at the last clinic attendance before delivery was 10.97g/dL and 10.94g/dL in the IPTp-SP and ISTp-AL groups respectively (mean difference: -0.03 g/dL [95% CI: -0.13, +0.06]). Active malaria infection of the placenta was found in 24.5% and in 24.2% of women in the IPTp-SP and ISTp-AL groups respectively (OR = 0.95 [95% CI 0.81, 1.12]). More women in the ISTp-AL than in the IPTp-SP group presented with malaria parasitemia between routine antenatal clinics (310 vs 182 episodes, rate difference: 49.4 per 1,000 pregnancies [95% CI 30.5, 68.3], but the number of hospital admissions for malaria was similar in the two groups.
  
  
  CONCLUSIONS
  Despite low levels of resistance to SP in the study areas, ISTp-AL performed as well as IPTp-SP. In the absence of an effective alternative medication to SP for IPTp, ISTp-AL is a potential alternative to IPTp in areas where SP resistance is high. It may also have a role in areas where malaria transmission is low and for the prevention of malaria in HIV positive women receiving cotrimoxazole prophylaxis in whom SP is contraindicated.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01084213 Pan African Clinical trials Registry PACT201202000272122.
authors.affiliation: London School of Hygiene & Tropical Medicine, London, United Kingdom; School of Public Health, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
authors.forename: Harry
authors.initials: H
authors.lastname: Tagbor
authors.affiliation: London School of Hygiene & Tropical Medicine, London, United Kingdom.
authors.forename: Matthew
authors.initials: M
authors.lastname: Cairns
authors.affiliation: Medical Research Council Unit, Fajara, The Gambia.
authors.forename: Kalifa
authors.initials: K
authors.lastname: Bojang
authors.affiliation: Faculty of Health Sciences, University of Ouagadougou, Ouagadougou, Burkina Faso.
authors.forename: Sheick Oumar
authors.initials: SO
authors.lastname: Coulibaly
authors.affiliation: Malaria Research and Training Centre, Faculty of Medicine and Odonto-stomatology, University of Sciences, Technics and Technologies, Bamako, Mali.
authors.forename: Kassoum
authors.initials: K
authors.lastname: Kayentao
authors.affiliation: Navrongo Health Research Centre, Navrongo, Ghana.
authors.forename: John
authors.initials: J
authors.lastname: Williams
authors.affiliation: Medical Research Council Unit, Fajara, The Gambia.
authors.forename: Ismaela
authors.initials: I
authors.lastname: Abubakar
authors.affiliation: Medical Research Council Unit, Fajara, The Gambia.
authors.forename: Francis
authors.initials: F
authors.lastname: Akor
authors.affiliation: Medical Research Council Unit, Fajara, The Gambia.
authors.forename: Khalifa
authors.initials: K
authors.lastname: Mohammed
authors.affiliation: Faculty of Health Sciences, University of Ouagadougou, Ouagadougou, Burkina Faso.
authors.forename: Richard
authors.initials: R
authors.lastname: Bationo
authors.affiliation: Faculty of Health Sciences, University of Ouagadougou, Ouagadougou, Burkina Faso.
authors.forename: Edgar
authors.initials: E
authors.lastname: Dabira
authors.affiliation: Faculty of Health Sciences, University of Ouagadougou, Ouagadougou, Burkina Faso.
authors.forename: Alamissa
authors.initials: A
authors.lastname: Soulama
authors.affiliation: Malaria Research and Training Centre, Faculty of Medicine and Odonto-stomatology, University of Sciences, Technics and Technologies, Bamako, Mali.
authors.forename: Moussa
authors.initials: M
authors.lastname: Djimdé
authors.affiliation: Malaria Research and Training Centre, Faculty of Medicine and Odonto-stomatology, University of Sciences, Technics and Technologies, Bamako, Mali.
authors.forename: Etienne
authors.initials: E
authors.lastname: Guirou
authors.affiliation: Navrongo Health Research Centre, Navrongo, Ghana.
authors.forename: Timothy
authors.initials: T
authors.lastname: Awine
authors.affiliation: Navrongo Health Research Centre, Navrongo, Ghana.
authors.forename: Stephen
authors.initials: S
authors.lastname: Quaye
authors.affiliation: Medical Research Council Unit, Fajara, The Gambia.
authors.forename: Fanta
authors.initials: F
authors.lastname: Njie
authors.affiliation: Barcelona Centre for International Health Research (CRESIB), Department of Pathology, Hospital Clinic-Universitat de Barcelona, Barcelona, Spain.
authors.forename: Jaume
authors.initials: J
authors.lastname: Ordi
authors.affiliation: Malaria Research and Training Centre, Faculty of Medicine and Odonto-stomatology, University of Sciences, Technics and Technologies, Bamako, Mali.
authors.forename: Ogobara
authors.initials: O
authors.lastname: Doumbo
authors.affiliation: Navrongo Health Research Centre, Navrongo, Ghana.
authors.forename: Abraham
authors.initials: A
authors.lastname: Hodgson
authors.affiliation: Navrongo Health Research Centre, Navrongo, Ghana.
authors.forename: Abraham
authors.initials: A
authors.lastname: Oduro
authors.affiliation: Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States of America.
authors.forename: Steven
authors.initials: S
authors.lastname: Meshnick
authors.affiliation: Duke University Medical Center, Durham, NC, United States of America.
authors.forename: Steve
authors.initials: S
authors.lastname: Taylor
authors.affiliation: (Institute of International Health, Immunology and Microbiology and Institute of Veterinary Disease Biology, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Pascal
authors.initials: P
authors.lastname: Magnussen
authors.affiliation: Liverpool School of Tropical Medicine, Liverpool, United Kingdom.
authors.forename: Feiko
authors.initials: F
authors.lastname: ter Kuile
authors.affiliation: London School of Hygiene & Tropical Medicine, London, United Kingdom.
authors.forename: Arouna
authors.initials: A
authors.lastname: Woukeu
authors.affiliation: London School of Hygiene & Tropical Medicine, London, United Kingdom.
authors.forename: Paul
authors.initials: P
authors.lastname: Milligan
authors.affiliation: London School of Hygiene & Tropical Medicine, London, United Kingdom.
authors.forename: Daniel
authors.initials: D
authors.lastname: Chandramohan
authors.affiliation: London School of Hygiene & Tropical Medicine, London, United Kingdom.
authors.forename: Brian
authors.initials: B
authors.lastname: Greenwood
mesh_terms: D000293:Adolescent; D000328:Adult; D000349:Africa; D000962:Antimalarials / Q000627:therapeutic use*; D001724:Birth Weight; D002050:Burkina Faso; D004338:Drug Combinations; D005260:Female; D005714:Gambia; D005869:Ghana; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008288:Malaria / Q000188:drug therapy*; D008302:Mali; D008403:Mass Screening; D010920:Placenta / Q000469:parasitology; D011247:Pregnancy; D015597:Pregnancy Complications, Parasitic / Q000175:diagnosis / Q000188:drug therapy*; D011256:Pregnancy Outcome; D011739:Pyrimethamine / Q000627:therapeutic use*; D013413:Sulfadoxine / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000962:Antimalarials; D004338:Drug Combinations; D006454:Hemoglobins; C001205:fanasil, pyrimethamine drug combination; D013413:Sulfadoxine; D011739:Pyrimethamine