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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)

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ClinicalTrials.gov Identifier: NCT01616615
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
Sara Varea, Fundacion Clinic per a la Recerca Biomédica

Tracking Information
First Submitted Date  ICMJE June 8, 2012
First Posted Date  ICMJE June 12, 2012
Last Update Posted Date August 18, 2015
Study Start Date  ICMJE September 2012
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2012)
Uterine artery mean pulsatility [ Time Frame: at 28 weeks of gestation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2012)
  • 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 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 + EB> 12 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation
Official Title  ICMJE Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Placental Insufficiency
Intervention  ICMJE
  • Drug: Aspirin
    150 mg/day oral use
  • Drug: placebo
    1 capsule / day oral use
Study Arms  ICMJE
  • Experimental: ASPIRIN
    150 mg milligram(s)/ day oral use
    Intervention: Drug: Aspirin
  • Placebo Comparator: PLACEBO
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2015)
190
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2012)
270
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01616615
Other Study ID Numbers  ICMJE ASAP
2012-000622-22 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sara Varea, Fundacion Clinic per a la Recerca Biomédica
Study Sponsor  ICMJE Sara Varea
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: FRANCESC FIGUERAS, MD, PhD Hospital Clinic of Barcelona
PRS Account Fundacion Clinic per a la Recerca Biomédica
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP