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

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 Overview

• Status: Completed
• Conditions: Placental Insufficiency
• Intervention / Treatment: Drug: Aspirin; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08028
    • Hospital Clinic of Barcelona
  • Barcelona, Spain, 08028
    • Institut Dexeus
  • Zaragoza, Spain, 50009
    • Hospital Clinico Lozano Blesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: PLACEBO	Drug: placebo; 1 capsule / day oral use
Experimental: ASPIRIN; 150 mg milligram(s)/ day oral use	Drug: Aspirin; 150 mg/day oral use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sara Varea
• Investigators: Principal Investigator: FRANCESC FIGUERAS, MD, PhD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: June 8, 2012
• First Submitted That Met QC Criteria: June 8, 2012
• First Posted (Estimate): June 12, 2012

Study Record Updates

• Last Update Posted (Estimate): August 18, 2015
• Last Update Submitted That Met QC Criteria: August 17, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Placenta Diseases; Placental Insufficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: ASAP; 2012-000622-22 (EudraCT Number)