Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation
ASAP
2 other identifiers
interventional
190
1 country
3
Brief Summary
To establish wether a prophylactic intervention from first trimester with low-dose of aspirin improves trophoblastic invasion evaluated at third trimester in women defined as high-risk by abnormal uterine artery Doppler at first trimester
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2012
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2012
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedAugust 18, 2015
June 1, 2015
2.6 years
June 8, 2012
August 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Uterine artery mean pulsatility
at 28 weeks of gestation
Secondary Outcomes (8)
Pre-eclampsia
delivery
Severe preeclampsia
at delivery
Intrauterine Growth Retardation
at delivery
Significant neonatal morbidity
at delivery
number of cesarean
at delivery
- +3 more secondary outcomes
Study Arms (2)
ASPIRIN
EXPERIMENTAL150 mg milligram(s)/ day oral use
PLACEBO
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients over 18 years old attending for routine ultrasound at first trimester of pregnancy between 11 and 14 weeks of gestation (Crown-to rump length 45-48mm)
- Single gestation
- Mean pulsatility index of the uterine arteries above the 95th percentile for our population
You may not qualify if:
- Pre-existing hypertension, renal or cardiovascular disease
- previous history of pre-eclampsia
- Pregestational diabetes
- Systemic lupus Erythematosus
- Gastric ulcer
- Acetylsalicylic acid or lactose hypersensitivity
- Bleeding disorders
- Fetal disorders (including chromosomal abnormalities)
- Administration of low molecular weight heparin
- Concomitant treatment with aspirin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sara Varealead
Study Sites (3)
Hospital Clinic of Barcelona
Barcelona, Barcelona, 08028, Spain
Institut Dexeus
Barcelona, Barcelona, 08028, Spain
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
FRANCESC FIGUERAS, MD, PhD
Hospital Clinic of Barcelona
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Trial Manager
Study Record Dates
First Submitted
June 8, 2012
First Posted
June 12, 2012
Study Start
September 1, 2012
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
August 18, 2015
Record last verified: 2015-06