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

Study Overview
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Brief Summary
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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

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

Conditions
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Placental Insufficiency

Intervention / Treatment
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* Drug: Aspirin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASPIRIN<br>150 mg milligram(s)/ day oral use | Drug: Aspirin<br>* 150 mg/day oral use<br>|
| Placebo Comparator: PLACEBO<br> | Drug: placebo<br>* 1 capsule / day oral use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine artery mean pulsatility |  | at 28 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-eclampsia | 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 | delivery | 
| Severe preeclampsia | 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). | at delivery | 
| Intrauterine Growth Retardation | 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. | at delivery | 
| Significant neonatal morbidity | 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 | at delivery | 
| number of cesarean | Emergent cesarean section due to fetal wellbeing loss Birth weight | at delivery | 
| Neonatal acidosis | Neonatal acidosis (arterial pH <7.10 + Base excess(BE)> 12 milliequivalent (mEq) / L) | at delivery | 
| Perinatal mortality | Perinatal mortality (> 22 weeks gestation, <28 days postpartum) | 28 days post partum | 
| Days in the Neonatal Intensive Care Unit |  | 28 days post partum |