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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01616615
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : August 18, 2015
Information provided by (Responsible Party):
Sara Varea, Fundacion Clinic per a la Recerca Biomédica

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

Condition or disease Intervention/treatment Phase
Placental Insufficiency Drug: Aspirin Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : September 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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

  2. 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).

  3. 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.

  4. 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

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

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

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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01616615

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Hospital Clinic of Barcelona
Barcelona, Spain, 08028
Institut Dexeus
Barcelona, Spain, 08028
Hospital Clínico Lozano Blesa
Zaragoza, Spain, 50009
Sponsors and Collaborators
Sara Varea
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Principal Investigator: FRANCESC FIGUERAS, MD, PhD Hospital Clinic of Barcelona
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Responsible Party: Sara Varea, Clinical Trial Manager, Fundacion Clinic per a la Recerca Biomédica Identifier: NCT01616615    
Other Study ID Numbers: ASAP
2012-000622-22 ( EudraCT Number )
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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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