Prevention of malaria during pregnancy: intermittent preventive treatment with two versus three doses of sulfadoxine-pyrimethamine

ISRCTN	ISRCTN74189211
DOI	https://doi.org/10.1186/ISRCTN74189211
Protocol serial number	N/A
Sponsor	National Direction of Health (Mali)
Funder	National Direction of Health (Mali)

Submission date: 27/01/2010
Registration date: 13/05/2010
Last edited: 21/07/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Oumou Maiga
Scientific

DNS-Mali
Bamako
BP:23
Mali

Study information

Primary study design	Interventional
Study design	Open randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	We hypothesised that intermittent preventive treatment (IPT)-three doses will be as efficacious as IPT-two doses of sulfadoxine-pyrimethamine (SP).
Ethics approval(s)	Ethical committee of Faculty of Medicine, Pharmacy and Odonto-stomatology, University of Bamako approved on the 31st March 2006
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Sulfadoxine-pyrimethamine
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.
Key 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.
Completion date	22/02/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	812
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	21/04/2006
Date of final enrolment	22/02/2010

Locations

Countries of recruitment

Mali

Study participating centre

DNS-Mali

Bamako
BP:23
Mali

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes