ISRCTN13633058已完成3 期
Combined multi-marker screening and randomised patient treatment with ASpirin for evidence-based PRE-eclampsia prevention
niversity College London (UK)0 个研究点目标入组 1,760 人开始时间: 2011年1月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,760
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 12/03/2013:
- •1. Aged 18 years or over
- •2. Singleton pregnancies
- •3. Live fetus at 11-13 weeks of gestation
- •4. High-risk for preterm pre-eclampsia will be defined at 11-13 weeks by the algorithm combining maternal history and characteristics, biophysical findings (mean arterial pressure and uterine artery Dopplers) and biochemical factors (pregnancy associated plasma protein-A [PAPP-A] and placental growth factor [PlGF]).
- •Previous inclusion criteria until 12/03/2013:
- •All singleton pregnancies with a live foetus at 11+0 - 13+6 weeks of gestation.
排除标准
- •Current exclusion criteria as of 28/04/2014:
- •1. Multiple pregnancies
- •2. Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment
- •3. Women who are unconscious or severely ill, those with learning difficulties, and serious mental illness
- •4. Bleeding disorders such as Von Willebrand?s disease
- •5. Peptic ulceration
- •6. Hypersensitivity to aspirin or already on long term non-steroidal anti-inflammatory medication
- •7. Age < 18 years
- •8. Women taking low-dose aspirin regularly
- •9. Concurrent participation in another drug trial or at any time within the previous 28 days
- •10. Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol
- •Exclusion criteria from 12/03/2013 to 28/04/2014:
- •1. Multiple pregnancies
- •2. Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment
- •3. Women who are unconscious or severely ill, those with learning difficulties, and serious mental illness
- •4. Bleeding disorders such as Von Willebrand?s disease
- •5. Peptic ulceration
- •6. Hypersensitivity to aspirin or already on long term non-steroidal anti-inflammatory medication
- •7. Age < 18 years
- •Original exclusion criteria until 12/03/2013:
- •1. Major foetal abnormalities identified at the 11+0 - 13+6 weeks assessment
- •2. Women who are unconscious or severely ill
- •3. Learning difficulties
- •4. Serious mental illness
- •5. Women with bleeding disorders
- •6. Peptic ulceration
- •7. Hypersensitivity to aspirin
- •8. Under the age of 18 years
研究者
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