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Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda

Assessment of the Efficacy of Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01184911
Acronym
SP IPTp
Enrollment
0
Registered
2010-08-19
Start date
2010-10-31
Completion date
2011-09-30
Last updated
2015-03-05

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

Conditions

Intermittent Preventive Treatment, Placental Malaria

Keywords

Malaria, Pregnancy

Brief summary

The effectiveness of sulfadoxine-pyrimethamine (SP) as intermittent preventive treatment in pregnancy in malaria-endemic areas the effectiveness and efficacy of SP may be compromised by increased SP resistance. This study will evaluate the efficacy of SP by giving SP to asymptomatic parasitemic pregnant women and following them to determine the rates of parasite clearance.

Interventions

DRUGSulfadoxine-pyrimethamine

Sulfadoxine-pyrimethamine tablets, once

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
Uganda Malaria Surveillance Project
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* 16-26 weeks gestation based on LMP or ultrasound or fundal height * Axillary temperature \<37.5 degrees C * Informed consent * HIV status known and negative * Blood smear positive for falciparum malaria

Exclusion criteria

* History of hypersensitivity reaction to SP or components of SP * Axillary temperature ≥37.5 degrees C * History of receipt of antimalarials or antibiotics with antimalarial activity\* in the past month * Residence \> 30 km from the ANC clinic or unwillingness to return for follow-up visits * Hemoglobin level \< 5 gm/dL * These medications include all antimalarials, rifampin, doxycycline, clindamycin, tetracycline, erythromycin, azithromycin, chloramphenicol.

Design outcomes

Primary

MeasureTime frameDescription
Parasite clearance42 daysClearance of parasites in pregnant women with asymptomatic parasitemia after administration of SP

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026