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Prevention of malaria during pregnancy: intermittent preventive treatment with two versus three doses of sulfadoxine-pyrimethamine
ISRCTN ISRCTN74189211
DOI 10.1186/ISRCTN74189211
ClinicalTrials.gov identifier
EudraCT number
Public title Prevention of malaria during pregnancy: intermittent preventive treatment with two versus three doses of sulfadoxine-pyrimethamine
Scientific title Intermittent preventive treatment with two versus three doses of sulfadoxine-pyrimethamine for the prevention of malaria during pregnancy in Mali: an open randomised controlled trial
Acronym N/A
Serial number at source N/A
Study hypothesis We hypothesised that intermittent preventive treatment (IPT)-three doses will be as efficacious as IPT-two doses of sulfadoxine-pyrimethamine (SP).
Lay summary Not provided at time of registration
Ethics approval Ethical committee of Faculty of Medicine, Pharmacy and Odonto-stomatology, University of Bamako approved on the 31st March 2006
Study design Open randomised controlled trial
Countries of recruitment Mali
Disease/condition/study domain Malaria during pregnancy
Participants - inclusion criteria 1. Aged 14 to 45 years, female pregnant women
2. Gestational age between 16 and 24 weeks
3. Provide consent form
4. Not having chronic disease
5. Willing to terminate the study and follow study conditions
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 21/04/2006
Anticipated end date 22/02/2010
Status of trial Completed
Patient information material Not available in web format, please contact Dr Kassoum Kayentao at kayentao@mrtcbko.org to request a patient information sheet
Target number of participants 406 in each treatment arm (812 in total)
Interventions Through an open label block randomisation (block size of 20); women were assigned to receive one of the treatment regimens (two or three doses of SP). One treatment dose was 1500 mg of sulfadoxine and 75 mg of pyrimethamine. Sequence of dosing admistration was as follows:
1. Women in the three-doses received the first dose between the 4th - 6th month of gestation, the second dose between 5th - 7th month of gestation, and the third dose no later that the 8th month of gestation
2. Women in the two-dose group received the first dose between the 4th - 6th month of gestation and the second dose no later than the 8th month of gestation. Doses were administered at least one month apart.

All drugs were administered directly by the study team and women were observed for 30 minutes following dosing. Study participants were asked to avoid self medication of anti-malrials other than the study medication and to return to the clinic for scheduled monthly assessment or any unscheduled sick visits. Women received ferrous sulphate (200 mg containing 60 mg of iron) and folic acid (0.4 mg) daily starting two weeks after each SP dosing as recommended by the Ministry of Health.

If malaria was diagnosed during subsequent visits, oral quinine was given 600 mg three times a day over 7 consecutive days.
Primary outcome measure(s) Placental malaria. Placental blood was collected from the maternal side of the placenta (after cleaning using filter paper before cutting with cleaned lancet) for thick blood smear for parasitaemia detection.
Secondary outcome measure(s) 1. Low birth weight. Gestational age at delivery was assessed using the Ballard score, and infants were weighed using a digital scale within 24 hours of delivery to measure the incidence of low birth weight.
2. Maternal anaemia. Following delivery, haemoglobin concentration was measured by HemoCue® (Hemocue 201: Anglholm, Sweden) and peripheral parasitaemia was assessed by peripheral blood smear.
Sources of funding National Direction of Health (Mali)
Trial website
Publications 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21765069
Contact name Dr  Oumou  Maiga
  Address DNS-Mali
  City/town Bamako
  Zip/Postcode BP:23
  Country Mali
Sponsor National Direction of Health (Mali)
  Address Tomikorobougou
  City/town Bamako
  Zip/Postcode BP:23
  Country Mali
  Sponsor website: http://dnsmali.net
Date applied 27/01/2010
Last edited 21/07/2011
Date ISRCTN assigned 13/05/2010
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