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临床试验/NCT00258024
NCT00258024已完成不适用

Control of Pregnancy Associated Malaria With Intermittent Preventive Treatment Through Community Involvement in Rural Ghana

DBL -Institute for Health Research and Development1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2005年11月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
420
试验地点
1
主要终点
Birth weight

研究概览

简要总结

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.

详细描述

General Objective To evaluate an alternative strategy of community involvement in the control of pregnancy associated malaria and anaemia in an area of intense malaria transmission in Ghana.

Specific Objectives To explore local knowledge and health-care practices of control of malaria in pregnancy and determine factors influencing utilization of antenatal services by pregnant women.

To determine the prevalence of malaria and anaemia in pregnancy in the Afigya Sekyere district To determine the effect of intermittent preventive treatment on pregnancy outcome in primigravidae and secundigravidae To evaluate the effectiveness of a health facility and a community-based malaria intervention in first and second pregnancies

Methodology Study area and population The study will be conducted in the Afigya Sekyere district of the Ashanti Region of Ghana. The district lies within the forest belt where malaria prevalence is highest (AHMED, 1989). Mean temperature is 270C with annual rainfall between 1500 and 2000mm. The major rainfall season is between March-July and the minor in September - November. There is little seasonal variation in malaria parasite transmission and rates are just slightly higher after the rains. Most of the inhabitants are peasant farmers.The district is divided into six sub districts with 91 communities.It has 15 health facilities (2 hospitals, 6 health centres, 2 clinics and 5 maternity homes). The district has about 42 trained (TTBAs) and a number of untrained TBAs who conduct almost 30% of deliveries in the district (DHA, 2002).Considering the inadequate number of health professionals coupled with their exodus to developed countries, the capabilities of TBAs can be enhanced and used in control of malaria in pregnancy.

Study Design Pre-intervention phase A baseline Survey on birth weights will be carried out to determine the mean birth weight and birth weight distribution in the study area

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Birth weight

anaemia

parasitaemia

fever episodes

次要结局

未报告次要终点

研究者

发起方
DBL -Institute for Health Research and Development
申办方类型
Other

研究点 (1)

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