Clinical trial NCT03536000: Fetal Cardiac Function Evaluation With aCMQ-Strain Fetal (STRAIN)
Official title: Evaluation of Fetal Cardiac Function With aCMQ-STRAIN: Normality Curve and Comparison to Fetus With Cardiac Disfunction Risk Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Cardiac Disorder
Keywords: Cardiac function
Fetal
Strain
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those healthy pregnant women who come to our hospital to perform the morphological ultrasound of the 2nd trimester, or pregnant women with pregestational diabetes, or with a diagnosis of intrauterine growth restriction and / or preeclampsia will be invited to participate in the study. For this, the Participant Information sheet in the study will be provided and the Informed Consent will be signed.

Those patients who wish to participate in the study will be cited for the performance of an echocardiography using the aCMQ-Strain method at week 24, 28, 32 and 36 of gestation.

All the tests will be carried out in the same study center and will be carried out by independent scouts.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the shortening of cardiac fibers during cardiac cycle
timeFrame: At 24, 28, 32 and 36 weeks of gestation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Elisa LLurba, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Mieghem T. Re: Descriptive analysis of different phenotypes of cardiac remodeling in fetal growth restriction. M. Rodriguez-Lopez, M. Cruz-Lemini, B. Valenzuela-Alcaraz, L. Garcia-Otero, M. Sitges, B. Bijnens, E. Gratacos and F. Crispi. Ultrasound Obstet Gynecol 2017; 50: 207-214. Ultrasound Obstet Gynecol. 2017 Aug;50(2):154. doi: 10.1002/uog.17541. No abstract available.
citation: Crispi F, Gratacos E. Fetal cardiac function: technical considerations and potential research and clinical applications. Fetal Diagn Ther. 2012;32(1-2):47-64. doi: 10.1159/000338003. Epub 2012 May 17.
citation: Comas M, Crispi F, Cruz-Martinez R, Martinez JM, Figueras F, Gratacos E. Usefulness of myocardial tissue Doppler vs conventional echocardiography in the evaluation of cardiac dysfunction in early-onset intrauterine growth restriction. Am J Obstet Gynecol. 2010 Jul;203(1):45.e1-7. doi: 10.1016/j.ajog.2010.02.044. Epub 2010 May 10.