Automated Myocardial Performance Index Using Samsung HERA W10

Congenital Diaphragmatic Hernia Clinical Trial

Official title:

Automated Myocardial Performance Index Before, During and After Fetal Surgeries Using Samsung HERA W10

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04140669
• Other study ID #: 18-005189
• Status: Terminated
• Start date: September 16, 2019
• Est. completion date: July 7, 2020

Study information

• Verified date: July 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Researchers are using Myocardial performance index (MPI) to assess fetal cardiac function before, during, and after fetal surgery in order to gain more knowledge about fetal cardiac function in high risk pregnancies and the relationship to outcomes of fetal surgical interventions.

Description:

This study will evaluate the cardiac function in fetuses with specific conditions before, during, and after fetal interventions using an automated myocardial performance index. It is hypothesized that automated MPI can used to diagnosis and predict fetal cardiac dysfunction in fetal surgeries.

Ultrasound examination, including Doppler assessment, has served an axial rule in diagnosis and management of complex maternal-fetal conditions. Sonographic findings have been indicative of prognosis and have guided intervention at particular situations including intrauterine growth restriction and fetal alloimmunization. As researchers continue to investigate various sonographic parameters that would identify fetuses at increased risk of adverse outcomes, which would warrant intervention, fetal cardiac function has substantially attracted attention as a potential predictor of fetal status; subtle cardiac dysfunction may reflect functional adaptation to fetal insult.

Myocardial performance index (MPI) is a Doppler derived sonographic tool that is used to assess global fetal cardiac function. Higher MPI values have been proven to indicate ventricular dysfunction. Several studies have adopted the use of MPI as a part of fetal echocardiography, either to study normal values among fetal population or to assess fetal cardiac dysfunction in high risk pregnancy and in response to fetal intervention. Initial results have correlated MPI to adverse outcomes particularly in the presence of maternal and fetal disorders.

Fetal surgery is a unique stressful situation in which fetal cardiac function presents a critical aspect. In part, because underlying indications are commonly associated with clinically relevant myocardial dysfunction e.g. twin-to-twin transfusion syndrome (TTTS), congenital diaphragmatic hernia (CDH), neural tube defect (NTD) and lower urinary tract obstruction (LUTO). Moreover, surgery itself may be associated with significant fetal cardiac compromise. Therefore, perioperative (before, during and after the procedures) MPI may present a predictive parameter of fetal and neonatal outcomes in these high risk surgeries.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: July 7, 2020
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Pregnant women, aged 18 years or older, with one of the following prenatal diagnoses:

• Monochorionic diamniotic twin pregnancies complicated with TTTS

• Fetuses with CDH, but no other structural or chromosomal abnormalities

• Fetuses with NTD, but no other structural or chromosomal abnormalities

• Fetuses with LUTO, but no other structural or chromosomal abnormalities

• That provide written Informed Consent and is willing to comply with protocol requirements

Exclusion Criteria

• Presence of fetal cardiac anomalies, arrhythmias, associated morbid or lethal anomalies, chromosomal abnormalities

• Pregnancy complications that are known to impact fetal and neonatal outcomes (e.g. diabetes mellitus, hypertension, autoimmune disorders

Related Conditions & MeSH terms

• Congenital Diaphragmatic Hernia
• Fetofetal Transfusion
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital
• Lower Urinary Tract Infection
• Neural Tube Defects
• Spinal Dysraphism
• Twin to Twin Transfusion Syndrome
• Urinary Tract Infections

Intervention

Device:
• Automated Myocardial Performance Index (MPI)
Automated Myocardial Performance Index will be performed using Samsung HERA W10 prior too fetal surgical interventions, during surgery, and following surgery.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Automated MPI can used to diagnosis and predict fetal cardiac dysfunction in fetal surgeries.		48 hours post-operatively

External Links

•   Mayo Clinic Clinical Trials