Fetal Cardiac Function Evaluation With aCMQ-Strain Fetal (STRAIN)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Unknown

Conditions: Fetal Cardiac Disorder

Treatments: Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method

Study type: Observational

Funder types: Other

Identifiers

NCT03536000

IIBSP-CMQ-2017-99

Details and patient eligibility

About

To assess whether the aCQM-Strain ultrasound method allows a good analysis of fetal cardiac function. Establish normality parameters and compare it with fetuses with risk factors of cardiac dysfunction.

Full description

National unicentric observational study of follow-up study of a cohort. It has been decided to conduct a study of consecutive cases, including all patients who meet the inclusion criteria during the time of the study.

Until now, there has not been an easy and convenient method to determine fetal cardiac function. Recently a new Software (Automated Cardiac Motion Quantification aCMQ) has been developed, and it seems that allows an easier analysis of this one.

This study aims to analyze fetal heart function with the Strain method in healthy patients and then compare it with fetuses with risk factors for cardiac dysfunction.

Initially, healthy pregnant patients who agree to participate in the study will be cited, after signing the informed consent, in order to evaluate the normal fetal cardiac function and see how it is modified in the different weeks of gestation.

To do this, a fetal echocardiography will be performed by the investigators at week 24, 28, 32 and 36 of pregnancy, using the aCMQ-Strain method.

Once the investigators have established normality curves, fetuses with risk factors for cardiac dysfunction of women who agree to participate in the study will be analyzed. For this purpose, a fetal echocardiography at week 24, 28, 32 and 36 of gestation, using the aCMQ-Strain method will be performed.

All tests will be carried out in the same study center and will be carried out by independent scouts.The data obtained in each test will be collected in an anonymized database for further study.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients older than 18 years
• Pregnant women> 20 weeks gestation
• Understand and accept the study procedures and sign an informed consent.

Exclusion criteria

• Not being able to understand the nature of the study and / or the procedures to be followed.
• Not signing informed consent
• Under 18 years of age
• Not pregnant

Trial design

250 participants in 4 patient groups

Healthy women

Description:

* 200 Pregnant women * Over 18 years * Healthy * With the ability to understand and sign the informed Consent * With the ability to attend the established controls * Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation

Treatment:

Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method

Intrauterine Growth restriction

Description:

* Pregnant women * Over 18 years * Intrauterine Growth Reestriction(IUGR): fetuses with percentile Growth \<p3 or \<p10 with vascular Doppler alteration. * With the ability to understand and sign the informed Consent * With the ability to attend the established controls * Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation

Treatment:

Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method

Preeclampsia

Description:

* Pregnant women * Over 18 years * Preeclampsia: elevated blood pressure + Ratio Prot/Creatinin in urine\> 30 mg / mmol creatinin * With the ability to understand and sign the informed Consent * With the ability to attend the established controls * Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation

Treatment:

Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method

Diabetes Mellitus type 1

Description:

* Pregnant women * Over 18 years * Diabetes mellitus type1 * With the ability to understand and sign the informed Consent * With the ability to attend the established controls * Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation

Treatment:

Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method