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Control of Pregnancy Associated Malaria With Intermittent Preventive Treatment

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: NCT00258024
Recruitment Status : Completed
First Posted : November 24, 2005
Last Update Posted : February 21, 2008
Information provided by:
DBL -Institute for Health Research and Development

Brief Summary:
Malaria is one of the major causes of illness and mortality in Sub-Saharan Africa. In Ghana, malaria is the most important cause of morbidity and accounts for about 40% of outpatient contacts. Chemoprophylaxis and insecticide-impregnated bed nets are used for malaria control in pregnancy.Chloroquine is administered within the ANC package at health facilities in Ghana. However, many pregnant women in rural,low-income communities do not report for ANC or report late thereby increasing their risk of morbidity and mortality. Reasons for this include inaccessibility and high cost. As the gap between urban and rural health care and socioeconomic circumstances increase, malaria control remains the major challenge of the health sector. A facility-based intervention alone is not sufficient to have a significant or sustained impact on malaria control in pregnancy. Alternative strategies are needed for the delivery of malaria interventions to pregnant women in rural areas in Ghana. The overall objective of this study is to develop alternative strategies for community involvement for delivery of malaria interventions to pregnant women in rural Ghana. The project will be conducted in the Afigya Sekyere district in the Ashanti Region of Ghana. Interviews and focus group discussions will be conducted with pregnant women and community members focusing on local knowledge on control of malaria in pregnancy and factors influencing utilization of antenatal services. Women in their first and second pregnancies who are permanently resident in the study area will be included in the study using IPT with sulphadoxine-pyrimethamine (SP). The study population will be randomized to:Group 1 will receive clinic-supervised IPT-SP and daily folate/iron supplementation and Group 2 will access IPT-SP with daily folate/iron supplementation from trained traditional birth attendants (TBA). Midwives and TBAs will be trained in preparing thick blood smears and placenta biopsies for parasitological examination. Parasitaemia and Hb will be measured at entry and at delivery and fever episodes during pregnancy will be recorded. Study participants will be followed for adverse reactions within a week after drug administration. The effectiveness of community-based IPT for the control of malaria in pregnancy will be determined. The endpoints of the study will be birth weight, maternal anaemia, fever episodes and prevalence of peripheral and placental parasitaemia in the groups.

Condition or disease Intervention/treatment Phase
Anaemia Malaria Drug: IPT-sulphadoxinepyrimethamine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Control of Pregnancy Associated Malaria With Intermittent Preventive Treatment Through Community Involvement in Rural Ghana
Study Start Date : November 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Primary Outcome Measures :
  1. Birth weight
  2. anaemia
  3. parasitaemia
  4. fever episodes

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Primigravida
  • Secundigravida
  • Permanent resident
  • Hemoglobin (Hb) > 7 g/dl

Exclusion Criteria:

  • Hb < 7 g/dl
  • Allergy to sulpha
  • Multiple pregnancy
  • Chronic diseases

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): NCT00258024

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Afiya Sekyere district
Kumasi, Ashanti region, Ghana
Sponsors and Collaborators
DBL -Institute for Health Research and Development
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Principal Investigator: Victoria Bam, reg. nurse Dept. Community Health, School of Health Sciences, Kumasi University
Additional Information:
Layout table for additonal information Identifier: NCT00258024    
Other Study ID Numbers: ghana5.2.malaria
First Posted: November 24, 2005    Key Record Dates
Last Update Posted: February 21, 2008
Last Verified: February 2008
Keywords provided by DBL -Institute for Health Research and Development:
IPT-SP, pregnancy, malaria,Ghana
Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases