NCT02823743已完成不适用
Treatment of Recurrent Abortion With Low Dose Aspirin - a Randomized Placebo Controlled Trial
Göteborg University0 个研究点目标入组 400 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 主要终点
- Live birth
研究概览
简要总结
The aim of this study is to examine whether treatment with 75 mg aspirin daily compared with placebo could reduce the risk for a new miscarriage. The treatment starts when the pregnancy is detected on transvaginal ultrasound (around gestational week 6+) and continues to week 35/36. The study is a single center, randomized, placebo-controlled, double blind and stratified for age. 400 participants with the diagnosis idiopathic recurrent abortion are enrolled, 200 in each arm aspirin / placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 39 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •recurrent abortion (≤ 3 consecutive abortions in first trimester)
- •unknown etiology after work-up
- •willingness to be randomized
排除标准
- •previous participation in the study
- •known cause of recurrent abortion, requiring specific management
- •BMI above 35
- •IVF pregnancy if the reason for IVF was recurrent spontaneous abortion
- •ongoing treatment with aspirin for other reason
- •Sjoegren syndrome
研究组 & 干预措施
Low dose aspirin
Experimental
75 mg aspirin orally daily from gestational week 7-35
干预措施: Aspirin (Drug)
Placebo
Placebo Comparator
Placebo pill orally daily from gestational week 7-35
干预措施: Placebo (Drug)
结局指标
主要结局
Live birth
时间窗: delivery
次要结局
- Spontaneous abortion(up to 22 weeks)
- Vaginal bleeding(up to 42 weeks)
- Premature delivery(At delivery)
- intrauterine growth retardation, measured by ultrasound as percentage deviation(up to 42 weeks)
- Preeclampsia(up to 42 weeks)
- Pregnancy induced hypertension(up to 42 weeks)
- Placenta praevia(up to 42 weeks)
- Perinatal mortality(Third trimester and 28 days after delivery)
- Perinatal morbidity(28 days after delivery)
研究者
Annika Strandell
Associate professor
Göteborg University
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