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

Phase 2

Completed

• Conditions: Placental Insufficiency
• Interventions: Drug: Aspirin; Drug: placebo

• Registration Number: NCT01616615
• Lead Sponsor: Sara Varea

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 available

Study Timeline

• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-12
• Study Start: 2012-09
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASPIRIN	Aspirin	150 mg milligram(s)/ day oral use
PLACEBO	placebo	-

Primary Outcome Measures

Name	Time	Method
Uterine artery mean pulsatility	at 28 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Pre-eclampsia	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	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	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	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	at delivery	Emergent cesarean section due to fetal wellbeing loss Birth weight
Neonatal acidosis	at delivery	Neonatal acidosis (arterial pH \<7.10 + Base excess(BE)\> 12 milliequivalent (mEq) / L)
Perinatal mortality	28 days post partum	Perinatal mortality (\> 22 weeks gestation, \<28 days postpartum)
Days in the Neonatal Intensive Care Unit	28 days post partum

Trial Locations

Locations (3)

Institut Dexeus; 🇪🇸 Barcelona, Spain

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain

Hospital Clínico Lozano Blesa; 🇪🇸 Zaragoza, Spain