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

• Conditions: Pregnancy Related Conditions, Unspecified, Third Trimester; Echocardiography; Pregnancy Related Conditions, Unspecified, First Trimester; Pregnancy Related Conditions, Unspecified, Second Trimester; Ventricle Remodeling

• Registration Number: NCT04395014
• Lead Sponsor: Miguel Ayala León

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-14
• Last Update Submitted: 2020-05-14
• Study First Posted: 2020-05-20
• Last Update Posted: 2020-05-20
• Study Start: 2020-10-01
• Primary Completion: 2020-12-01
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Beneficencia Española de Puebla; 🇲🇽 Puebla, Mexico