This trial is active, not recruiting.

Condition preeclampsia
Treatments aspirin, placebo
Phase phase 3
Sponsor Rabin Medical Center
Collaborator University College, London
Start date December 2015
End date November 2016
Trial size 2 participants
Trial identifier NCT02301780, 0066-14-RMC


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
(Placebo Comparator)
(Active Comparator)

Primary Outcomes

Number of participants with Pre-eclampsia requiring delivery prior to 37 weeks of gestation
time frame: 24-26 Weeks

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Combined Multi-marker Screening and Randomised Patient Treatment With Aspirin for Evidence-based Pre-eclampsia Prevention. University College London - Sponsor of All EU Study Sites.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Rabin Medical Center.