Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Study hypothesis
We hypothesised that intermittent preventive treatment (IPT)-three doses will be as efficacious as IPT-two doses of sulfadoxine-pyrimethamine (SP).
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact Dr Kassoum Kayentao at kayentao@mrtcbko.org to request a patient information sheet
Condition
Malaria during pregnancy
Intervention
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.
Intervention type
Drug
Phase
Phase IV
Drug names
Sulfadoxine-pyrimethamine
Primary outcome measures
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 measures
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.
Overall trial start date
21/04/2006
Overall trial end date
22/02/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
406 in each treatment arm (812 in total)
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
21/04/2006
Recruitment end date
22/02/2010
Locations
Countries of recruitment
Mali
Trial participating centre
DNS-Mali
Bamako
BP:23
Mali
Sponsor information
Organisation
National Direction of Health (Mali)
Sponsor details
Tomikorobougou
Bamako
BP:23
Mali
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Direction of Health (Mali)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21765069
Publication citations
-
Results
Diakite OS, Maiga OM, Kayentao K, Traoré BT, Djimde A, Traoré B, Diallo M, Traoré M, Ongoiba A, Doumtabé D, Doumbo S, Traoré MS, Dara A, Guindo O, Karim DM, Coulibaly S, Bougoudogo F, Ter Kuile FO, Danis M, Doumbo OK, Superiority of 3 over 2 doses of intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria during pregnancy in mali: a randomized controlled trial., Clin. Infect. Dis., 2011, 53, 3, 215-223, doi: 10.1093/cid/cir374.