Combined Multi-marker Screening and Treatment With Aspirin for Pre-eclampsia Prevention

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

Phase III two arm double-blinded randomised controlled trial to examine the effect of prophylactic low-dose aspirin from the first-trimester of pregnancy in women at increased risk for PET on the incidence and severity of the disease

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rabin Medical Center
• Collaborator: University College, London
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Age > 18 years

• Singleton pregnancies

• Live fetus at 11-13 weeks of gestation,

• High-risk for preterm-PET at 11-13 weeks by the algorithm combining maternal history and characteristics, biophysical findings (mean arterial pressure and uterine artery Dopplers) and biochemical factors (pregnancy associated plasma protein-A and placental growth factor),

• English, Italian, Spanish, French, Flemish, Hebrew, Arabic and Russian speaking (otherwise interpreters will be used)

• Informed and written consent.

Exclusion Criteria:

• Multiple pregnancies

• Women taking low-dose aspirin regularly

• Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment

• Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness, Bleeding disorders such as Von Willebrand's disease

• Peptic ulceration

• Hypersensitivity to aspirin or already on long term nonsteroidal 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