Status:
COMPLETED
Combined Multi-marker Screening and Treatment With Aspirin for Pre-eclampsia Prevention
Lead Sponsor:
Rabin Medical Center
Collaborating Sponsors:
University College, London
Conditions:
Preeclampsia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 inci...
Detailed Description
Screening and Prevention of Pre-eclampsia (High Blood Pressure): Randomised Trial of Aspirin Versus Placebo (ASPRE) Screening: All women with singleton pregnancies undergoing routine screening for an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT02301780
Start Date
December 1 2015
End Date
October 1 2016
Last Update
November 9 2016
Active Locations (1)
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1
Rabin Medical Center
Petah Tikva, Israel