Clinical Trial: Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Sara Varea

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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:

• 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 ]

Dates:
Date Received: June 8, 2012
Date Started: September 2012
Date Completion:
Last Updated: August 17, 2015
Last Verified: June 2015