Prevention of Malaria During Pregnancy Using Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine: Malawi
Intermittent Preventive Treatment With Sulfadoxine/Pyrimethamine During Pregnancy Among HIV-Positive and HIV-Negative Women: 2-Dose Versus Monthly - Malawi
1 other identifier
interventional
700
1 country
1
Brief Summary
In Malawi, the standard of care to prevent malaria during pregnancy at the time of the study was a two dose sulfadoxine-pyrimethamine intermittent protective treatment (SP IPT) regimen administered in the second and third trimester of pregnancy. In this investigation, this two dose strategy was compared to a monthly SP regimen. The objective for the study was to determine the efficacy of the different regimens for HIV positive and HIV negative women in the prevention of placental malaria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2002
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 3, 2005
CompletedFirst Posted
Study publicly available on registry
August 5, 2005
CompletedAugust 23, 2005
August 1, 2005
August 3, 2005
August 22, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Placental malaria parasitemia rates measured at time of delivery, stratified by HIV status
Secondary Outcomes (3)
Proportion of newborns with low birth weight, stratified by HIV status
Proportion of women with third trimester anemia, stratified by HIV status
Proportion of pregnancies that suffer fetal loss, stratified by HIV status
Interventions
Eligibility Criteria
You may qualify if:
- First or second pregnancy
- Greater than 16 weeks gestation
- Less than 28 weeks gestation
- Consent for HIV testing
You may not qualify if:
- Less than 15 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Machinga District Hospital
Liwonde, Malawi
Related Publications (3)
Parise ME, Ayisi JG, Nahlen BL, Schultz LJ, Roberts JM, Misore A, Muga R, Oloo AJ, Steketee RW. Efficacy of sulfadoxine-pyrimethamine for prevention of placental malaria in an area of Kenya with a high prevalence of malaria and human immunodeficiency virus infection. Am J Trop Med Hyg. 1998 Nov;59(5):813-22. doi: 10.4269/ajtmh.1998.59.813.
PMID: 9840604BACKGROUNDPons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.
PMID: 39324693DERIVEDFiller SJ, Kazembe P, Thigpen M, Macheso A, Parise ME, Newman RD, Steketee RW, Hamel M. Randomized trial of 2-dose versus monthly sulfadoxine-pyrimethamine intermittent preventive treatment for malaria in HIV-positive and HIV-negative pregnant women in Malawi. J Infect Dis. 2006 Aug 1;194(3):286-93. doi: 10.1086/505080. Epub 2006 Jun 20.
PMID: 16826475DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott J Filler, MD, DTM&H
Centers for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- ECT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
August 3, 2005
First Posted
August 5, 2005
Study Start
October 1, 2002
Study Completion
March 1, 2005
Last Updated
August 23, 2005
Record last verified: 2005-08