NCT02338687已完成4 期
Low Dose Calcium Supplementation to Prevent Preeclampsia: a Cluster Randomized Study
Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 1,040 人开始时间: 2014年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,040
- 试验地点
- 2
- 主要终点
- Preeclampsia
研究概览
简要总结
The purpose of this study is to assess, in pregnant women with calcium-poor diets, what is the effectiveness of low-dose (500 mg/day) calcium supplements associated with an educational intervention, compared to the educational intervention alone, in the prevention of preeclampsia and hypertensive disorders during pregnancy.
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
- None
入排标准
- 年龄范围
- 10 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Capacity to understand verbal and visual instructions
- •Gestational age 16 - 20 weeks
- •Live fetus
排除标准
- •Hyperparathyroidism or other contra-indication to calcium supplementation
- •Gastrointestinal diseases or conditions that may interfere with calcium absorption (e.g. bariatric surgery, cancer, chronic colitis)
- •Use of medications that may interfere with calcium absorption (e.g. corticosteroids, thiazides, thyroid hormones)
- •Women already taking calcium supplements or daily antacids at recruitment
结局指标
主要结局
Preeclampsia
时间窗: at 20-40 weeks of pregnancy
New onset of hypertension plus proteinuria after 20 weeks of pregnancy
Hypertensive disorders of pregnancy
时间窗: at 20-40 weeks of pregnancy
New onset of hypertension, with or without proteinuria, after 20 weeks of pregnancy
次要结局
- Maternal admission to Intensive Care Unit(at 20-40 weeks of pregnancy)
- Preterm birth(at 20-36 weeks)
- Small for gestational age infant(at 20-40 weeks)
- Severe maternal morbidity(at 20-40 weeks of pregnancy)
- Mean change in dietary calcium intake(at 30-36 weeks of pregnancy)
- Gastrointestinal side effects of calcium(at 20-40 weeks of pregnancy)
- Low birth weight(at 20-40 weeks)
- Hospital admission due to hypertension(at 20-40 weeks of pregnancy)
- Maternal mortality(starting at 20 weeks up to hospital discharge)
- Admission to Neonatal Intensive Care Unit(from delivery to infant discharge)
研究者
Maria Regina Torloni
MD, PhD
Federal University of São Paulo
研究点 (2)
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