Echocardiographic Assessment of Ventricular Strain During a Healthy Pregnancy in the First, Second, and Third Trimester. (VStrain123P)

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 Overview

• Status: Unknown
• Conditions: Echocardiography; Pregnancy Related Conditions, Unspecified, First Trimester; Pregnancy Related Conditions, Unspecified, Second Trimester; Pregnancy Related Conditions, Unspecified, Third Trimester; Ventricle Remodeling
• Intervention / Treatment: Diagnostic test: 2D Echocardiography

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Mexico
  • Puebla, Mexico, 72090
    • Recruiting
    • Hospital Beneficencia Española de Puebla
    • Sub-Investigator: Victoria Delgado
    • Sub-Investigator: Juan José Carreño Cuecuecha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy pregnant women that coursing the first trimester of pregnancy.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Miguel Ayala León
• Collaborators: Leiden University Medical Center; Institute of Security and Social Services of Workers of the State of Puebla.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Pregnancy; Ventricular function; Strain ventricular
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Disease; Pregnancy Complications; Ventricular Remodeling
• Other Study ID Numbers: Cardiology-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No