Prenatal Iron Supplements: Safety and Efficacy in Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Infant birth weight
研究概览
简要总结
The purpose of this study is to determine safety and efficacy of prenatal iron supplementation in an area of high malaria burden among women who are not anemic or iron deficient.
详细描述
Iron deficiency anemia and malaria are urgent public health problems in sub-Saharan Africa, including Tanzania. There is a paucity of good quality randomized trials assessing the safety and efficacy of iron supplementation in pregnancy, and its effects on perinatal health outcomes. Prenatal iron supplementation is recommended based on its demonstrated benefit in preventing and treating maternal anemia. There is limited data on the efficacy of iron supplementation on pregnancy outcomes, including birth weight. There are also concerns regarding the use of iron supplementation, particularly among non-anemic women. In particular, there is a lack of research on the safety and efficacy of prenatal iron supplementation in developing regions, characterized by extensive burden of iron deficiency, malaria, and other endemic infectious diseases. Evidence from randomized controlled trials is urgently needed to examine the safety and efficacy of iron supplements among pregnant women in malaria endemic regions, particularly among women who are not anemic.
NOTE: The time frames listed for the maternal malaria and hemoglobin outcomes were updated on 4/22/15. This record initially indicated that maternal malaria anemia and hemoglobin would be measured at several specific time points throughout the study. Instead, maternal malaria was measured throughout pregnancy and hemoglobin was measured only at delivery. Due to an oversight, we did not update this record when this protocol change took effect at the start of the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •at or before 27 weeks of gestation
- •primigravida or secundigravidae
- •not anemic (defined as Hb<8.5 g/dL)
- •not iron deficient (defined as serum ferritin <12 μg/L)
- •HIV-uninfected
- •intend to stay in Dar es Salaam until delivery and for at least six weeks thereafter.
排除标准
- •After 27 weeks gestation
- •not primigravida or secundigravidae
- •iron deficient
- •HIV-infected
- •High iron stores at baseline (i.e., serum ferritin >200 μg/L)
- •do not intend to stay in Dar es Salaam until delivery and for at least six weeks thereafter.
结局指标
主要结局
Infant birth weight
时间窗: Delivery
Continuous measurement
Maternal hemoglobin
时间窗: Delivery
Continuous measurement
Placental malaria parasite density
时间窗: Delivery
Placental malaria parasite density will be defined as number of parasites per μL of blood or 200 white blood cells; the latter will be converted to a count per μL of blood assuming a count of 8000 WBC/μL.
Incidence of placental malaria
时间窗: Delivery
Placental infection status will be categorized as infected if there are asexual parasites in the placenta blood; not infected if the placental blood smear is negative; or status unknown if no placental smear is available.
次要结局
- Maternal malaria infection(During pregnancy)
- Maternal anemia(Delivery)
- Low birth weight(Delivery)
研究者
Wafaie Fawzi
Chair, Department of Global Health and Population
Harvard School of Public Health (HSPH)