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Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation (ASAP)

This study has been completed.
Information provided by (Responsible Party):
Sara Varea, Fundació Clínic per la Recerca Biomèdica Identifier:
First received: June 8, 2012
Last updated: August 17, 2015
Last verified: June 2015
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

Condition Intervention Phase
Placental Insufficiency Drug: Aspirin Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation

Resource links provided by NLM:

Further study details as provided by Sara Varea, Fundació Clínic per la Recerca Biomèdica:

Primary Outcome Measures:
  • Uterine artery mean pulsatility [ Time Frame: at 28 weeks of gestation ]

Secondary Outcome Measures:
  • Pre-eclampsia [ Time Frame: delivery ]
    pre-eclampsia defined as: diastolic blood pressure (DBP)> = 90 mmHg) or systolic (SBP)> = 140 mmHg on two separated determinations (> 4h) with proteinuria> 300 mg/24 h -Gestational age at debut of preeclampsia

  • Severe preeclampsia [ Time Frame: at delivery ]
    Severe preeclampsia defined as: preeclampsia criteria + DBP> = 110 mmHg, proteinuria> 5g/24h, oligouria (<400 ml/24h), neurological symptoms (brain or visual), acute pulmonary edema (gasometric and radiological criteria), persistent epigastric pain, abnormal liver function (AST or Alanine aminotransferase(ALT)> 70 IU), analytical signs of hemolysis (LDH> 700 U / L) and / or thrombocytopenia (<100.000/ml).

  • Intrauterine Growth Retardation [ Time Frame: at delivery ]
    Intrauterine Growth Retardation: birth weight below the 10th percentile of our population + pulsatility index in umbilical artery in the third trimester (on two separate occasions >48h)above the 95th percentile.

  • Significant neonatal morbidity [ Time Frame: at delivery ]
    Significant neonatal morbidity (convulsions, intraventricular hemorrhage> grade III, periventricular leukomalacia, hypoxic-ischemic encephalopathy, abnormal electroencephalogram, necrotizing enterocolitis, acute renal failure (serum creatinine> 1.5 mg / dl) or heart failure (requiring inotropic agents

  • number of cesarean [ Time Frame: at delivery ]
    Emergent cesarean section due to fetal wellbeing loss Birth weight

  • Neonatal acidosis [ Time Frame: at delivery ]
    Neonatal acidosis (arterial pH <7.10 + Base excess(BE)> 12 milliequivalent (mEq) / L)

  • Perinatal mortality [ Time Frame: 28 days post partum ]
    Perinatal mortality (> 22 weeks gestation, <28 days postpartum)

  • Days in the Neonatal Intensive Care Unit [ Time Frame: 28 days post partum ]

Enrollment: 190
Study Start Date: September 2012
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASPIRIN
150 mg milligram(s)/ day oral use
Drug: Aspirin
150 mg/day oral use
Placebo Comparator: PLACEBO Drug: placebo
1 capsule / day oral use


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01616615

Hospital Clinic of Barcelona
Barcelona, Spain, 08028
Institut Dexeus
Barcelona, Spain, 08028
Hospital Clínico Lozano Blesa
Zaragoza, Spain, 50009
Sponsors and Collaborators
Sara Varea
Principal Investigator: FRANCESC FIGUERAS, MD, PhD Hospital Clinic of Barcelona
  More Information

Responsible Party: Sara Varea, Clinical Trial Manager, Fundació Clínic per la Recerca Biomèdica Identifier: NCT01616615     History of Changes
Other Study ID Numbers: ASAP
2012-000622-22 ( EudraCT Number )
Study First Received: June 8, 2012
Last Updated: August 17, 2015

Additional relevant MeSH terms:
Placental Insufficiency
Placenta Diseases
Pregnancy Complications
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics processed this record on July 24, 2017