Efficacy of Magnesium and Alpha Lipoic Acid Supplementation in Reducing Premature Uterine Contractions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- Number of women with frequent and persistent episodes of preterm uterine contractions associated with pain
研究概览
简要总结
To evaluate whether a combined supplementation of magnesium and lipoic acid is able to significantly reduce the incidence of uterine contractions and related episodes of hospitalization in pregnant women.
详细描述
Primary prevention of preterm labor is based on the early identification of risk factors and on appropriate treatments. Although several drugs are currently used, the identification of effective and safe agents able to improve both maternal and fetal health is still warranted.
In this study the efficacy a formulation based on magnesium and alpha-lipoic acid has been compared with placebo to evaluate the incidence of reduction of preterm delivery.
Three hundred pregnant women at 14-34 weeks of gestation were enrolled and randomly divided to receive a daily single tablet containing magnesium and alpha-lipoic acid supplement or placebo until delivery.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 23 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •14-34 weeks of gestation
排除标准
- •Preexisting diabetes mellitus
- •Systolic blood pressure >140mm Hg
- •hepatitis
- •Diagnosed alcohol or chemical dependency
研究组 & 干预措施
Magnesium + Lipoic Acid
干预措施: Magnesium plus alpha-lipoic acid (Dietary Supplement)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of women with frequent and persistent episodes of preterm uterine contractions associated with pain
时间窗: From baseline (beginning of the treatment) until delivery
Number of women with sporadic episodes of preterm uterine contraction
时间窗: From baseline (beginning of the treatment) until delivery
Number of women needed for hospital admission for threatened preterm labour
时间窗: From baseline (beginning of the treatment) until delivery
次要结局
未报告次要终点