EUCTR2013-003778-29-ITActive, not recruitingPhase 1
Combined Multi-Marker Screening and Randomised Patient Treatment with Aspirin for Evidence-based Pre-eclampsia Prevention - ASPRE (Version 1)
niversity College London0 sites1,684 target enrollmentStarted: February 28, 2014Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,684
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •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 and French speaking (otherwise NHS Trust interpreters, in the UK 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 0
Exclusion Criteria
- •Multiple pregnancies
- •Pregnancies complicated by major fetal abnormality identified at the 11-13
- •weeks assessment
- •Women taking low-dose aspirin regularly
- •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
- •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
Investigators
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