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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy women |
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| Intrauterine Growth restriction |
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| Preeclampsia |
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| Diabetes Mellitus type 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fetal echocardiography using the aCMQ-Strain method | Diagnostic Test | Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the shortening of cardiac fibers during cardiac cycle | Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) | At 24, 28, 32 and 36 weeks of gestation |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisa Llurba, PhD | Contact | 935537041 | ellurba@santpau.cat | |
| Carla DomÃnguez, MD | Contact | 687691793 | cdominguezg@santpau.cat |
| Name | Affiliation | Role |
|---|---|---|
| Elisa LLurba, PhD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28782233 | Background | 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. | |
| 22614129 |
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| ID | Term |
|---|---|
| D013180 | Sprains and Strains |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Background |
| 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. |
| 20451892 | Background | 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. |