Automated Myocardial Performance Index Using Samsung HERA W10

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

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.

Study Overview

• Status: Terminated
• Conditions: Congenital Diaphragmatic Hernia; Neural Tube Defects; Twin to Twin Transfusion Syndrome; Lower Urinary Tract Infection
• Intervention / Treatment: Device: Automated Myocardial Performance Index (MPI)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women carrying a fetus with a diagnosis of TTTS, fetal NTD, fetal CDH, or fetal LUTO, and planning to undergo a fetal surgical procedure.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fetal Surgery Procedures; All pregnant women with a fetus diagnosed with a fetal abnormality and planning to undergo a fetal surgical procedure will be included in this single arm of the study.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Automated MPI can used to diagnosis and predict fetal cardiac dysfunction in fetal surgeries.	48 hours post-operatively

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 16, 2019
• Primary Completion (ACTUAL): July 7, 2020
• Study Completion (ACTUAL): July 7, 2020

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (ACTUAL): October 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Infections; Urologic Diseases; Congenital Abnormalities; Hematologic Diseases; Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Anemia; Internal Hernia; Nervous System Malformations; Hernia; Anemia, Neonatal; Urinary Tract Infections; Hernias, Diaphragmatic, Congenital; Hernia, Diaphragmatic; Neural Tube Defects; Spinal Dysraphism; Fetofetal Transfusion
• Other Study ID Numbers: 18-005189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes