Automated Myocardial Performance Index Using Samsung HERA W10

Terminated

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

• Registration Number: NCT04140669
• Lead Sponsor: Mayo Clinic

Brief 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.

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 Timeline

• Study Start: 2019-09-16
• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-28
• Primary Completion: 2020-07-07
• Study Completion: 2020-07-07
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fetal Surgery Procedures	Automated Myocardial Performance Index (MPI)	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States