Preventing Unnecessary Blood Transfusions in Pregnant Women in Africa Through Effective Primary Health Care
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Incidence of severe anemia (Hb < 7 g/dL)
研究概览
简要总结
The purpose of this research is to compare the efficacy of two low-cost low intervention packages to prevent and treat severe anemia in pregnant women in Zanzibar, Tanzania. The two packages are Standard of Care as described by the WHO (presumptive treatment for malaria and helminths plus daily iron + folic acid supplements) and Enhanced Care (Standard of Care plus daily multivitamins and a 2nd dose of anthelminthic.)
详细描述
This is a clinic-randomized trial involving 8 antenatal clinics and approximately 2500 women. The specific aims are:
Aim 1: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the prevention of severe anemia among pregnant Zanzibari women. This aim will be achieved through a pre-post intervention comparison.
Aim 2: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to prevent severe anemia among pregnant Zanzibari women.
Aim 3: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the cure of severe anemia among pregnant Zanzibari women.
Aim 4: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to cure severe anemia among pregnant Zanzibari women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant woman
排除标准
- •Not a permanent resident of the community
结局指标
主要结局
Incidence of severe anemia (Hb < 7 g/dL)
Cure of severe anemia
次要结局
- Infant birth weight
- Neonatal mortality
- Neonatal morbidity
- Blood loss during delivery