Effectiveness of Intermittent Screening and Treatment of Malaria in Pregnancy (ISTp) on Maternal and Birth Outcomes in Selected Districts in Rwanda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Jhpiego
- 入组人数
- 1,786
- 试验地点
- 14
- 主要终点
- Prevalence of placental malaria at delivery (tested by PCR)
研究概览
简要总结
The main aim of this study is to test the primary hypothesis that the addition of intermittent screening and treatment of malaria in pregnant women (ISTp) who receive routine antenatal care (ANC) in health facilities in high malaria transmission areas in Rwanda will reduce malaria prevalence among pregnant women when compared to routine antenatal cares services alone.
详细描述
More specifically, the primary objective is to understand the effect of ISTp in a context where routine antenatal care does not include malaria chemoprohylaxis and whether this intervention is protective against malaria during pregnancy. The secondary objective is to determine whether this intervention results in an improvement in other key maternal and newborn health outcomes including maternal anemia, low birth weight and prematurity. The third objective is to determine the feasibility, effectiveness and acceptability of ISTp among women who receive ISTp and among health workers who deliver this intervention.
This study will establish if testing and treating pregnant women is effective, feasible and whether it adds an additional burden to the work already being undertaken by facility-based health workers who provide antenatal care services. It is expected that the study will result in information to develop appropriate approaches that can be implemented in Rwanda in the prevention of malaria in pregnancy in addition to the use of preventive measures such as insecticide treated mosquito nets (ITNs) and case management. This information may potentially also be used by other countries with similar patterns of malaria transmission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women age 18 or older who have their first ANC visit during the study recruitment period
- •Willing to participate
排除标准
- •• Pregnant women below the age of 18
- •Not willing to participate
结局指标
主要结局
Prevalence of placental malaria at delivery (tested by PCR)
时间窗: at the time of delivery
comparison of prevalence of malaria between women in intervention and control sites
次要结局
- Prevalence of low birth weight babies (<37 weeks gestation)(at the time of delivery)
- Prevalence of maternal anemia at delivery(at the time of delivery)
- Prevalence of preterm births(at the time of delivery)
- Episodes of clinical malaria during the course of the pregnancy(assessed at the time of delivery)