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Safety and efficacy of artemether-lumefantrine therapy for Intermittent Preventive Treatment in pregnancy in Uganda

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12394097
Enrollment
1664
Registered
2006-10-05
Start date
2007-02-12
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 in pregnancy Infections and Infestations Malaria

Interventions

Study Arm A: Artemether-lumefantrine given as four tablets twice daily for three days for each IPTp dose three times during the pregnancy Study Arm B: Sulphadoxine-pyrimethamine given as three tablets

Sponsors

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Pregnant with a gestational age between 20 to 28 weeks 2. Residing within a radius of 20 miles from the hospital 3. Attending AnteNatal Clinic (ANC) and has not yet received regular programme IPTp with SP 4. Attending ANC and last received anti-malarial treatment greater than one month ago 5. Gives informed consent for study participation 6. Able to come for follow-up

Exclusion criteria

Exclusion criteria: 1. Known allergy to SP or artemether-lumefantrine 2. Previously diagnosed with Glucose-6-phosphate dehydrogenase deficiency 3. Presently ill with a medical condition requiring admission to hospital 4. Known patient with cardiac disease or arrhythmia 5. Intrauterine foetal death in the current pregnancy

Design outcomes

Primary

MeasureTime frame
Prevalence and severity of placental parasitaemia at delivery

Secondary

MeasureTime frame
1. Prevalence of low birth weight (less than 2500 g) at delivery 2. Prevalence and severity of peripheral parasitaemia during pregnancy until delivery 3. Prevalence of anaemia (haemoglobin less than 10 g/dl) at 34 weeks and at delivery

Countries

Uganda

Outcome results

None listed

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