Screening and prevention of pre-eclampsia (high blood pressure): Randomised trial of aspirin versus placebo

Phase 1

Conditions: Pre-eclampsia
MedDRA version: 18.0Level: PTClassification code 10036485Term: Pre-eclampsiaSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2013-003778-29-GR

Lead Sponsor: niversity College London

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 1684

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, 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

Exclusion Criteria

• 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