TerminatedNot Applicable

Automated Myocardial Performance Index Using Samsung HERA W10

Stopped: Sponsor support and funding was terminated due to pandemic

United States7 participantsStarted 2019-09-16

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Automated MPI can used to diagnosis and predict fetal cardiac dysfunction in fetal surgeries.

Timeframe: 48 hours post-operatively

Trial details

NCT IDNCT04140669

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-07-07

View on ClinicalTrials.gov More Twin to Twin Transfusion Syndrome trials