Control of Pregnancy Associated Malaria With Intermittent Preventive Treatment

This study has been completed.
Sponsor:
Information provided by:
DBL -Institute for Health Research and Development
ClinicalTrials.gov Identifier:
NCT00258024
First received: November 23, 2005
Last updated: February 19, 2008
Last verified: February 2008
  Purpose

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 Intervention
Anaemia
Malaria
Drug: IPT-sulphadoxinepyrimethamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Control of Pregnancy Associated Malaria With Intermittent Preventive Treatment Through Community Involvement in Rural Ghana

Resource links provided by NLM:


Further study details as provided by DBL -Institute for Health Research and Development:

Primary Outcome Measures:
  • Birth weight
  • anaemia
  • parasitaemia
  • fever episodes

Estimated Enrollment: 420
Study Start Date: November 2005
Study Completion Date: October 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Hb < 7 g/dl
  • Allergy to sulpha
  • Multiple pregnancy
  • Chronic diseases
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258024

Locations
Ghana
Afiya Sekyere district
Kumasi, Ashanti region, Ghana
Sponsors and Collaborators
DBL -Institute for Health Research and Development
Investigators
Principal Investigator: Victoria Bam, reg. nurse Dept. Community Health, School of Health Sciences, Kumasi University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00258024     History of Changes
Other Study ID Numbers: ghana5.2.malaria
Study First Received: November 23, 2005
Last Updated: February 19, 2008
Health Authority: Ghana:Committee on human research publication and ethics

Keywords provided by DBL -Institute for Health Research and Development:
IPT-SP, pregnancy, malaria,Ghana

Additional relevant MeSH terms:
Anemia
Malaria
Hematologic Diseases
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on July 29, 2014