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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74189211
Enrollment
812
Registered
2010-05-13
Start date
2006-04-21
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria during pregnancy Infections and Infestations Plasmodium falciparum malaria

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 a

Sponsors

National Direction of Health (Mali)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Mali

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026