Working… Menu

Prevention of Malaria During Pregnancy Using Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine: Malawi

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00126906
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : August 23, 2005
Ministry of Health and Population, Malawi
Information provided by:
Centers for Disease Control and Prevention

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.

Condition or disease Intervention/treatment Phase
Malaria, Falciparum HIV Infections Drug: Monthly sulfadoxine/pyrimethamine Drug: 2-dose sulfadoxine/pyrimethamine Not Applicable

Detailed Description:
In this protocol the researchers wish to elaborate prior investigations on factors which may affect prevalence and malarial parasite density in pregnant women in Malawi. Primarily, this investigation will evaluate the efficacy of the current Malawian national policy, sulfadoxine-pyrimethamine (SP) 2-dose intermittent protective treatment (IPT) strategy, and compare it to a monthly SP strategy for use in preventing malaria during pregnancy. Previous investigations in Malawi have demonstrated that: prevention of malaria during pregnancy is most important during the first and second pregnancies, particularly during the rainy season when malaria transmission is highest; and an efficacious antimalarial regimen which clears parasitemia and placental infection will result in a reduction in the incidence of low birth weight, the single greatest risk factor for neonatal and early infant mortality. There appears to be an interaction between HIV infection and placental malaria, with HIV-positive pregnant women having higher prevalences and densities of peripheral and placental parasitemia compared with HIV-negative pregnant women. This finding requires closer examination, in light of the high prevalence and incidence of HIV infection in Malawi and other African countries. Previously in Malawi, a 2-dose IPT regimen of SP administered during the second and third trimester of pregnancy was effective at clearing placental malaria infection at delivery More recent studies in both Malawi and Kenya show that 2 doses may not be adequate in clearing placental parasitemia especially in women who are HIV infected. In the Kenya study, HIV-positive women required 3 doses of SP (that were delivered in a monthly dosing scheme) to achieve similar reductions in placental parasitemia that were seen in HIV-negative women at 2 doses. There remains a need to identify the optimal dosing schedule for an intermittent treatment regimen; the Kenya findings need to be confirmed before decisions are made on national and global levels. This is especially important given the possibility of increasing SP resistance in Malawi. The question of HIV infection and its role in malaria during pregnancy, both in terms of impact on regimen effectiveness and on the incidence of adverse sulfa reactions needs to be examined. This study proposes to determine the efficacy of the current regimen of 2-dose SP intermittent protective treatment (IPT) and to compare it to monthly SP dosing in clearing placental parasitemia at delivery in Machinga district in Malawi where there is a high level of malaria transmission and an HIV seropositivity rate of nearly 20% in reproductive age woman. This study will also explore the effect of HIV seropositivity on the safety and efficacy of intermittent preventive treatment during pregnancy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Intermittent Preventive Treatment With Sulfadoxine/Pyrimethamine During Pregnancy Among HIV-Positive and HIV-Negative Women: 2-Dose Versus Monthly - Malawi
Study Start Date : October 2002
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Placental malaria parasitemia rates measured at time of delivery, stratified by HIV status

Secondary Outcome Measures :
  1. Proportion of newborns with low birth weight, stratified by HIV status
  2. Proportion of women with third trimester anemia, stratified by HIV status
  3. Proportion of pregnancies that suffer fetal loss, stratified by HIV status

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • First or second pregnancy
  • Greater than 16 weeks gestation
  • Less than 28 weeks gestation
  • Consent for HIV testing

Exclusion Criteria:

  • Less than 15 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00126906

Layout table for location information
Machinga District Hospital
Liwonde, Malawi
Sponsors and Collaborators
Centers for Disease Control and Prevention
Ministry of Health and Population, Malawi
Layout table for investigator information
Principal Investigator: Scott J Filler, MD, DTM&H Centers for Disease Control and Prevention
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00126906    
Other Study ID Numbers: CDC-NCID-3429
First Posted: August 5, 2005    Key Record Dates
Last Update Posted: August 23, 2005
Last Verified: August 2005
Keywords provided by Centers for Disease Control and Prevention:
Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents