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

NCT ID: NCT04395014

Last Updated: 2020-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-08-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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2D 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role collaborator

Institute of Security and Social Services of Workers of the State of Puebla.

UNKNOWN

Sponsor Role collaborator

Miguel Ayala León

NETWORK

Sponsor Role lead

Responsible Party

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Miguel Ayala León

cardiovascular critical care unit director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital Beneficencia Española de Puebla

Puebla City, , Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Miguel Ayala León, MD

Role: CONTACT

5529625396

Facility Contacts

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Miguel Ayala León, Cardiolology

Role: primary

5529625396

Other Identifiers

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Cardiology-003

Identifier Type: -

Identifier Source: org_study_id

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