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

NCT03536000 | Unknown

• 1 other identifier: IIBSP-CMQ-2017-99
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fetal Cardiac Disorder

Keywords

Cardiac function; Fetal; Strain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Healthy women

* 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

Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method

Intrauterine Growth restriction

* 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

Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method

Preeclampsia

* 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

Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method

Diabetes Mellitus type 1

* 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

Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method

Interventions

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

Diabetes Mellitus type 1; Healthy women; Intrauterine Growth restriction; Preeclampsia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Related Publications (3)

• 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.

  PMID: 28782233 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.

  PMID: 22614129 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.

  PMID: 20451892 BACKGROUND

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Elisa LLurba, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Llurba, PhD

CONTACT

935537041; ellurba@santpau.cat

Carla Domínguez, MD

CONTACT

687691793; cdominguezg@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 24, 2018
• Study Start: May 28, 2018
• Primary Completion: April 11, 2019
• Study Completion: September 11, 2019
• Last Updated: May 24, 2018

Record last verified: 2018-05