EUCTR2019-003341-15-AT招募中1 期
Aspirin versus placebo in twin pregnancies for preeclampsia prevention: A multicentre, randomised, double-blind, placebo-controlled trial (ASPRE-T) - Aspirin versus placebo in twin pregnancies for preeclampsia prevention
Fundación para la Formación e Investigación Sanitaria0 个研究点目标入组 2,400 人开始时间: 2022年7月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,400
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
- •Age > 18 years;
- •DCDA or MCDA twin pregnancies;
- •Both live fetuses at 11+2-13+6 weeks of gestation;
- •Informed and written consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2400
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Monoamniotic twins
- •Triplet pregnancies that had undergone embryo reduction to twins or with one vanishing twin
- •Pregnancies complicated by major fetal abnormality or nuchal translucency thickness >3.5 mm identified at the 11+2-13+6 weeks scan;
- •MCDA twin pregnancies in which there are early signs of TTTS or sFGR defined by a 20% discordance in CRL at the 11+2-13+6 weeks’ scan;
- •Those who lack capacity and who are unable to provide informed consent to take part;
- •Women taking low-dose aspirin regularly (administration must have ceased >7 days prior to randomization);
- •Participation in another drug trial within the previous 7 days;
- •Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia or concurrent anticoagulant therapy;
- •Active or history of recurrent peptic ulceration and/or gastric/intestinal haemorrhage, or other kinds of bleeding such as cerebrovascular haemorrhages;
- •Patients who are suffering from known gout, severe hepatic impairment or severe renal impairment;
- •Hypersensitivity to salicylic acid compounds or prostaglandin synthetase inhibitors (e.g. certain asthma patients who may suffer an attack or faint and certain patients who may suffer from bronchospasm, rhinitis and urticaria) or to any excipients (see section 6.1 of the SmPC for details);
- •Patients on long term non-steroidal anti-inflammatory medication;
- •Not fluent in local language and absence of interpreter
- •Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.
研究者
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