Vitamin C and E Supplementation in Pregnant Women With Low Antioxidant Status
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- preeclampsia cases
研究概览
简要总结
The purpose of this study is to investigate antioxidants supplementation in pregnant women with low antioxidant status at 10-12 weeks gestation age in relation to adverse pregnancy outcome in randomized prospective study.
详细描述
Preeclampsia still remains a leading cause of feto-maternal mortality and morbidity in developed and developing world. Despite of intensive research, the underlying pathologic mechanisms of this disease remain elusive. It has been agreed that incomplete or absent transformation of spiral arteries by replacing endothelial cells and mural vascular smooth muscle cells has been observed in the placental bed of preeclamptic patients and severe cases of intrauterine growth restriction. Oxidative stress has been proposed as a link between these mechanisms. However, it has been demonstrated by two large studies that antioxidant supplementation does not reduce the risk of preeclampsia. Our initial study has been shown that antioxidant supplementation may be reduce the risk of preeclampsia in pregnant women with low antioxidant status.
Comparison(s): adverse pregnancy outcome between vitamin C and E given and placebo given to pregnant women with low antioxidant status at 10-12 weeks gestation age
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
- 17 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Agree to consent form, and consent to protocol of research
- •Known healthy singleton 6-10 weeks pregnant women
排除标准
- •Blood pressure > 135/85
- •Proteinuria
- •History or current use of anti-hypertensive medication or diuretics
- •Use of vitamins C > 150 mg and/or E > 75 IU per day
- •Pregestational diabetes
- •Known placental abnormalities.
- •Current pregnancy is a result of in vitro fertilization
- •Regular use of platelet active drugs or non-steroidal anti-inflammatory drugs
- •Known fetal abnormalities
- •Documented uterine bleeding within a week of screening
- •Uterine malformations
- •History of medical complications
- •Illicit drug or alcohol abuse during current pregnancy
- •Intent to deliver elsewhere
- •Known psychologic problems.
- •Participating in another interventional study
结局指标
主要结局
preeclampsia cases
次要结局
- adverse pregnancy outcome