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

Sara Varea190 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

190

Conditions

Placental Insufficiency

Interventions

AspirinDRUG

150 mg/day oral use

placeboDRUG

1 capsule / day oral use

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Hospital Clinic of Barcelona

Barcelona, Barcelona, Spain

Institut Dexeus

Barcelona, Barcelona, Spain

Hospital Clínico Lozano Blesa

Zaragoza, Zaragoza, Spain

Outcomes

Primary Outcomes

Uterine artery mean pulsatility

Time frame: at 28 weeks of gestation

Secondary Outcomes

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

Time frame: 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).

Time frame: 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.

Time frame: 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

Time frame: at delivery

number of cesarean

Emergent cesarean section due to fetal wellbeing loss Birth weight

Time frame: at delivery

Data from ClinicalTrials.gov

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