Echocardiographic Assessment of Ventricular Strain During a Healthy Pregnancy in the First, Second, and Third Trimester.

Overview

Pregnancy is a physiological situation that produces transient preload and afterload changes. The heart is subjected to reversible morphological remodelings and hemodynamic and functional adaptations. The characterization and understanding of maternal cardiac function during normal pregnancy by echocardiography 2D is of clinical importance for the opportune recognition of cardiac pathology.

This study aims to investigate pregnancy-induced changes in ventricular strain in healthy pregnant women by echocardiography.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 1, 2020

Interventions

  • Diagnostic Test: 2D Echocardiography
    • In this echocardiographic imaging acquisition protocol, the pregnancy patients, are colocated in the left lateral decubitus position on a clinical bed with the left arm flex and the hand behind the head. All the echocardiographic measurements are taken by the examiner in this position.

Clinical Trial Outcome Measures

Primary Measures

  • Left ventricular telediastolic diameter (LVTDd)
    • Time Frame: 3 minutes
    • Left ventricular telediastolic diameter (mm)
  • Left ventricular telesystolic diamete (LVTSd)
    • Time Frame: 3 minutes
    • Left ventricular telesystolic diameter (mm)
  • Interventricular septum (IVS)
    • Time Frame: 3 minutes
    • Diameter of Interventricular septum (mm)
  • Left ventricular posterior wall (LVPW)
    • Time Frame: 3 minutes
    • Left ventricle posterior wall (mm)
  • Ejection fraction (EF)
    • Time Frame: 3 minutes
    • Ejection fraction (%)
  • Right atrium area (RA area)
    • Time Frame: 3 minutes
    • Right atrium area (cm2)
  • Right ventricle B
    • Time Frame: 3 minutes
    • Right ventricle basal dimension (mm)
  • Right ventricular M
    • Time Frame: 3 minutes
    • Right ventricle mid cavity dimension (mm)
  • Right ventricular L
    • Time Frame: 3 minutes
    • Right ventricle longitudinal dimension (mm)
  • Right ventricle outflow tract dimension at the proximal subvalvular level (RVOT p)
    • Time Frame: 3 minutes
    • Right ventricle outflow tract dimension at the proximal subvalvular level (mm)
  • Right ventricle outflow tract dimension at the distal or pulmonic valve level (RVOT d)
    • Time Frame: 3 minutes
    • Right ventricle outflow tract dimension at the distal or pulmonic valve level (mm)
  • Tricuspid annular plane systolic excursion (TAPSE)
    • Time Frame: 3 minutes
    • Tricuspid annular plane systolic excursion (mm)
  • Right ventricle free wall (RV free wall)
    • Time Frame: 3 minutes
    • Right ventricle free wall (mm)
  • Inferior cava vein (ICV)
    • Time Frame: 3 minutes
    • Inferior cava vein (mm)
  • Left atrium volume index (LA volume index)
    • Time Frame: 3 minutes
    • Left atrium volume index (mL/m2)
  • E mitr
    • Time Frame: 3 minutes
    • Mitral E wave (cm/s)
  • A mitr
    • Time Frame: 3 minutes
    • Mitral A wave (cm/s)
  • E/A mitr
    • Time Frame: 3 minutes
    • Mitral E wave / Mitral A wave
  • Sm
    • Time Frame: 3 minutes
    • S-wave at mitral anulus (cm/s)
  • Em
    • Time Frame: 3 minutes
    • E-wave at mitral annulus (cm/s)
  • Am
    • Time Frame: 3 minutes
    • A-wave at mitral annulus (cm/s)
  • Em/Am
    • Time Frame: 3 minutes
    • E-wave at mitral annulus/ A-wave at mitral annulus
  • E/Em
    • Time Frame: 3 minutes
    • E wave/ E-wave at the mitral annulus
  • E tric
    • Time Frame: 3 minutes
    • Tricuspid E wave (cm/s)
  • A tric (cm/s)
    • Time Frame: 3 minutes
    • Tricuspid A wave (cm/s)
  • E/A tric
    • Time Frame: 3 minutes
    • Tricuspid E wave/Tricuspid A wave
  • St
    • Time Frame: 3 minutes
    • S-wave at tricuspid anulus(cm/s)
  • Et
    • Time Frame: 3 minutes
    • E-wave at tricuspid anulus(cm/s)
  • At
    • Time Frame: 3 minutes
    • A-wave at tricuspid anulus (cm/s)
  • Et/At
    • Time Frame: 3 minutes
    • E-wave at tricuspid anulus /A-wave at tricuspid anulus
  • Mean pulmonary artery pressure (mPAP)
    • Time Frame: 3 minutes
    • Mean pulmonary artery pressure (mmHg)
  • Systolic pulmonary artery pressure (sPAP)
    • Time Frame: 3 minutes
    • Systolic pulmonary artery pressure (mmHg)
  • Stroke volume (SV)
    • Time Frame: 3 minutes
    • Stroke volume (mL)
  • Cardiac output (CO)
    • Time Frame: 3 minutes
    • Cardiac output (L/min)
  • Strain right ventricle (Strain RV)
    • Time Frame: 3 minutes
    • Strain right ventricle
  • Strain left ventricle (Strain LV)
    • Time Frame: 3 minutes
    • Strain left ventricle

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥18 years and < 35
  • Patients who coursing the first trimester of pregnancy
  • No history or symptoms of cardiovascular or lung disease
  • No ongoing or previous cardio or vasoactive treatment
  • Normal ECG
  • Normal physical examination
  • Able to give informed consent

Exclusion Criteria

  • Poor acoustic window
  • Obesity in the first trimester (body mass index [BMI], ≥30 kg/m2)
  • Inability to provide consent.
  • Tricuspid regurgitation more than mild
  • Collagen disease
  • Professional sports activity
  • Twin pregnancy
  • Hyperthyroidism

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Miguel Ayala León
  • Collaborator
    • Leiden University Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Miguel Ayala León, cardiovascular critical care unit director – Hospital Beneficencia Espanola de Puebla
  • Overall Contact(s)
    • Miguel Ayala León, MD, 5529625396, librocardiocritica.ma@hotmail.com

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