Combined Multi-Marker Screening and Randomised Patient Treatment with Aspirin for Evidence-based Pre-eclampsia Prevention - ASPRE

niversity College London0 个研究点目标入组 1,684 人开始时间: 2015年7月23日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•Age =18 years
•Singleton pregnancies
•Live fetus at 11-13 weeks of gestation
•High-risk for preterm preeclampsia will be defined at 11-13 weeks by the algorithm combining maternal history, biophysical findings (mean arterial blood pressure and uterine artery Dopplers) and biochemical factors (PAPP-A and PlGF)
•English, Italian, Spanish, French, Flemish, Hebrew, Arabic, Russian or Greek speaking (otherwise interpreters will be used)
•Informed and written consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1684
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Multiple pregnancies
•Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment
•Women taking low-dose aspirin regularly (administration must have ceased >28 days prior to randomisation)
•Women who are unconscious or severely ill, those with learning difficulties, and serious mental illness
•Bleeding disorders such as Von Willebrand’s disease
•Peptic ulceration
•Hypersensitivity to aspirin or already on long term non-steroidal anti-inflammatory medication
•Age < 18 years
•Concurrent participation in another drug trial or at any time within the previous 28 days
•Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol

发起方

niversity College London