NCT04395014

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

May 14, 2020

Last Update Submit

May 14, 2020

Conditions

EchocardiographyPregnancy Related Conditions, Unspecified, First TrimesterPregnancy Related Conditions, Unspecified, Second TrimesterPregnancy Related Conditions, Unspecified, Third TrimesterVentricle Remodeling

Keywords

Strain ventricularPregnancyVentricular function

Outcome Measures

Primary Outcomes (36)

  • 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

Interventions

2D EchocardiographyDIAGNOSTIC_TEST

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.

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy pregnant women that coursing the first trimester of pregnancy.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Beneficencia Española de Puebla

Puebla City, 72090, Mexico

RECRUITING

MeSH Terms

Conditions

Ventricular Remodeling

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Central Study Contacts

Miguel Ayala León, MD

CONTACT

5529625396librocardiocritica.ma@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR INVESTIGATOR
PI Title
cardiovascular critical care unit director

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 20, 2020

Study Start

October 1, 2020

Primary Completion

December 1, 2020

Study Completion

August 31, 2021

Last Updated

May 20, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)