NCT05449171已完成不适用
Efficacy of the Association of Hyaluronic Acid With High Molecular Weight, α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion in Patients at Risk
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of metrorrhagia and/or pelvic pain in the first trimester of gestation.
研究概览
简要总结
The study aims to verify if the association of high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D, reduces the risk of miscarriage in patients at risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •two or more previous spontaneous first trimester abortions without apparent risk factors (idiopathic polyabortion)
- •Endocrinopathies
- •Autoimmune diseases
- •Thrombophililic or coagulation diseases
排除标准
- •Multiple pregnancies
- •Presence of genetic abnormalities of one or both partners leading to increased risk of fetal aneuploidies
- •Presence of Mullerian abnormalities in the uterus
- •Symptoms present at recruitment such as pelvic pain or metrorrhagia
研究组 & 干预措施
Control group
No Intervention
Treatment group
Experimental
干预措施: high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D (Other)
结局指标
主要结局
Incidence of metrorrhagia and/or pelvic pain in the first trimester of gestation.
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (2)
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