Control of Pregnancy Associated Malaria With Intermittent Preventive Treatment

NCT00258024 | Completed

• 1 other identifier: ghana5.2.malaria
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaemia; Malaria

Keywords

IPT-SP, pregnancy, malaria,Ghana

Outcome Measures

Primary Outcomes (4)

• Birth weight

• anaemia

• parasitaemia

• fever episodes

Interventions

IPT-sulphadoxinepyrimethamine DRUG

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• DBL -Institute for Health Research and Development: lead

Study Sites (1)

Afiya Sekyere district

Kumasi, Ashanti Region, Ghana

Location

Related Links

• Related Info

MeSH Terms

Conditions

Anemia; Malaria

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Victoria Bam, reg. nurse

  Dept. Community Health, School of Health Sciences, Kumasi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2005
• First Posted: November 24, 2005
• Study Start: November 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: October 1, 2007
• Last Updated: February 21, 2008

Record last verified: 2008-02

Locations

GH (1)