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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04395014
Acronym
VStrain123P
Enrollment
50
Registered
2020-05-20
Start date
2020-10-01
Completion date
2021-08-31
Last updated
2020-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Strain ventricular, Pregnancy, Ventricular function

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.

Interventions

DIAGNOSTIC_TEST2D 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.

Sponsors

Leiden University Medical Center
CollaboratorOTHER
Institute of Security and Social Services of Workers of the State of Puebla.
CollaboratorUNKNOWN
Miguel Ayala León
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Left ventricular telediastolic diameter (LVTDd)3 minutesLeft ventricular telediastolic diameter (mm)
Left ventricular telesystolic diamete (LVTSd)3 minutesLeft ventricular telesystolic diameter (mm)
Interventricular septum (IVS)3 minutesDiameter of Interventricular septum (mm)
Left ventricular posterior wall (LVPW)3 minutesLeft ventricle posterior wall (mm)
Ejection fraction (EF)3 minutesEjection fraction (%)
Right atrium area (RA area)3 minutesRight atrium area (cm2)
Right ventricle B3 minutesRight ventricle basal dimension (mm)
Right ventricular M3 minutesRight ventricle mid cavity dimension (mm)
Right ventricular L3 minutesRight ventricle longitudinal dimension (mm)
Right ventricle outflow tract dimension at the proximal subvalvular level (RVOT p)3 minutesRight 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 minutesRight ventricle outflow tract dimension at the distal or pulmonic valve level (mm)
Tricuspid annular plane systolic excursion (TAPSE)3 minutesTricuspid annular plane systolic excursion (mm)
Right ventricle free wall (RV free wall)3 minutesRight ventricle free wall (mm)
Inferior cava vein (ICV)3 minutesInferior cava vein (mm)
Left atrium volume index (LA volume index)3 minutesLeft atrium volume index (mL/m2)
E mitr3 minutesMitral E wave (cm/s)
A mitr3 minutesMitral A wave (cm/s)
E/A mitr3 minutesMitral E wave / Mitral A wave
Sm3 minutesS-wave at mitral anulus (cm/s)
Em3 minutesE-wave at mitral annulus (cm/s)
Am3 minutesA-wave at mitral annulus (cm/s)
Em/Am3 minutesE-wave at mitral annulus/ A-wave at mitral annulus
E/Em3 minutesE wave/ E-wave at the mitral annulus
E tric3 minutesTricuspid E wave (cm/s)
A tric (cm/s)3 minutesTricuspid A wave (cm/s)
E/A tric3 minutesTricuspid E wave/Tricuspid A wave
St3 minutesS-wave at tricuspid anulus(cm/s)
Et3 minutesE-wave at tricuspid anulus(cm/s)
At3 minutesA-wave at tricuspid anulus (cm/s)
Et/At3 minutesE-wave at tricuspid anulus /A-wave at tricuspid anulus
Mean pulmonary artery pressure (mPAP)3 minutesMean pulmonary artery pressure (mmHg)
Systolic pulmonary artery pressure (sPAP)3 minutesSystolic pulmonary artery pressure (mmHg)
Stroke volume (SV)3 minutesStroke volume (mL)
Cardiac output (CO)3 minutesCardiac output (L/min)
Strain right ventricle (Strain RV)3 minutesStrain right ventricle
Strain left ventricle (Strain LV)3 minutesStrain left ventricle

Countries

Mexico

Contacts

Primary ContactMiguel Ayala León, MD
librocardiocritica.ma@hotmail.com5529625396

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026