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

Phase 4

Withdrawn

• Conditions: Intermittent Preventive Treatment; Placental Malaria
• Interventions: Drug: Sulfadoxine-pyrimethamine

• Registration Number: NCT01184911
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-17
• Study First Submitted QC: 2010-08-17
• Study First Posted: 2010-08-19
• Study Start: 2010-10
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-03
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SP	Sulfadoxine-pyrimethamine	Asymptomatic parasitemic pregnant women who receive the standard dose of sulfadoxine-pyrimethamine for prevention of placental malaria

Primary Outcome Measures

Name	Time	Method
Parasite clearance	42 days	Clearance of parasites in pregnant women with asymptomatic parasitemia after administration of SP

Trial Locations

Locations (1)

Infectious Disease Research Center; 🇺🇬 Tororo, Uganda