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 range

18 Years

Sex

FEMALE

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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