NCT01616615已完成2 期
Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation
Sara Varea3 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 3
- 主要终点
- Uterine artery mean pulsatility
研究概览
简要总结
To establish wether a prophylactic intervention from first trimester with low-dose of aspirin improves trophoblastic invasion evaluated at third trimester in women defined as high-risk by abnormal uterine artery Doppler at first trimester
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old attending for routine ultrasound at first trimester of pregnancy between 11 and 14 weeks of gestation (Crown-to rump length 45-48mm)
- •Single gestation
- •Mean pulsatility index of the uterine arteries above the 95th percentile for our population
排除标准
- •Pre-existing hypertension, renal or cardiovascular disease
- •previous history of pre-eclampsia
- •Pregestational diabetes
- •Systemic lupus Erythematosus
- •Gastric ulcer
- •Acetylsalicylic acid or lactose hypersensitivity
- •Bleeding disorders
- •Fetal disorders (including chromosomal abnormalities)
- •Administration of low molecular weight heparin
- •Concomitant treatment with aspirin
研究组 & 干预措施
ASPIRIN
Experimental
150 mg milligram(s)/ day oral use
干预措施: Aspirin (Drug)
PLACEBO
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Uterine artery mean pulsatility
时间窗: at 28 weeks of gestation
次要结局
- Pre-eclampsia(delivery)
- Severe preeclampsia(at delivery)
- Intrauterine Growth Retardation(at delivery)
- Significant neonatal morbidity(at delivery)
- number of cesarean(at delivery)
- Neonatal acidosis(at delivery)
- Perinatal mortality(28 days post partum)
- Days in the Neonatal Intensive Care Unit(28 days post partum)
研究者
Sara Varea
Clinical Trial Manager
Fundacion Clinic per a la Recerca Biomédica
研究点 (3)
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