Clinical trial NCT04395014: Echocardiographic Assessment of Ventricular Strain During a Healthy Pregnancy in the First, Second, and Third Trimester.
Official title: Echocardiographic Assessment of Ventricular Strain During a Healthy Pregnancy in the First, Second, and Third Trimester.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Hospital Beneficencia Espanola de Puebla
Sponsor class: NETWORK
Collaborators: name: Leiden University Medical Center
name: Institute of Security and Social Services of Workers of the State of Puebla.
First posted: 2020-05-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy pregnant women that coursing the first trimester of pregnancy.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular telediastolic diameter (LVTDd)
timeFrame: 3 minutes
measure: Left ventricular telesystolic diamete (LVTSd)
timeFrame: 3 minutes
measure: Interventricular septum (IVS)
timeFrame: 3 minutes
measure: Left ventricular posterior wall (LVPW)
timeFrame: 3 minutes
measure: Ejection fraction (EF)
timeFrame: 3 minutes
measure: Right atrium area (RA area)
timeFrame: 3 minutes
measure: Right ventricle B
timeFrame: 3 minutes
measure: Right ventricular M
timeFrame: 3 minutes
measure: Right ventricular L
timeFrame: 3 minutes
measure: Right ventricle outflow tract dimension at the proximal subvalvular level (RVOT p)
timeFrame: 3 minutes
measure: Right ventricle outflow tract dimension at the distal or pulmonic valve level (RVOT d)
timeFrame: 3 minutes
measure: Tricuspid annular plane systolic excursion (TAPSE)
timeFrame: 3 minutes
measure: Right ventricle free wall (RV free wall)
timeFrame: 3 minutes
measure: Inferior cava vein (ICV)
timeFrame: 3 minutes
measure: Left atrium volume index (LA volume index)
timeFrame: 3 minutes
measure: E mitr
timeFrame: 3 minutes
measure: A mitr
timeFrame: 3 minutes
measure: E/A mitr
timeFrame: 3 minutes
measure: Sm
timeFrame: 3 minutes
measure: Em
timeFrame: 3 minutes
measure: Am
timeFrame: 3 minutes
measure: Em/Am
timeFrame: 3 minutes
measure: E/Em
timeFrame: 3 minutes
measure: E tric
timeFrame: 3 minutes
measure: A tric (cm/s)
timeFrame: 3 minutes
measure: E/A tric
timeFrame: 3 minutes
measure: St
timeFrame: 3 minutes
measure: Et
timeFrame: 3 minutes
measure: At
timeFrame: 3 minutes
measure: Et/At
timeFrame: 3 minutes
measure: Mean pulmonary artery pressure (mPAP)
timeFrame: 3 minutes
measure: Systolic pulmonary artery pressure (sPAP)
timeFrame: 3 minutes
measure: Stroke volume (SV)
timeFrame: 3 minutes
measure: Cardiac output (CO)
timeFrame: 3 minutes
measure: Strain right ventricle (Strain RV)
timeFrame: 3 minutes
measure: Strain left ventricle (Strain LV)
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Puebla
country: Mexico
facility: Hospital Beneficencia Española de Puebla
Study officials:
References: