Twin to Twin Transfusion SyndromeNCT04140669
Automated Myocardial Performance Index Using Samsung HERA W10
An observational study of Twin to Twin Transfusion Syndrome and Congenital Diaphragmatic Hernia, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Twin to Twin Transfusion Syndrome, Congenital Diaphragmatic Hernia, Neural Tube Defects
- What is being tested?
- Automated Myocardial Performance Index (MPI)
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2019to 7 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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.
- Conditions
- Twin to Twin Transfusion Syndrome, Congenital Diaphragmatic Hernia, Neural Tube Defects, Lower Urinary Tract Infection
- Being tested
- Automated Myocardial Performance Index (MPI)
- Medical subject headings
- Fetofetal Transfusion, Hernias, Diaphragmatic, Congenital, Neural Tube Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Myocardial Performance Index (MPI)Device
Automated Myocardial Performance Index will be performed using Samsung HERA W10 prior too fetal surgical interventions, during surgery, and following surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Automated Myocardial Performance Index (MPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Automated MPI can used to diagnosis and predict fetal cardiac dysfunction in fetal surgeries.
Measured: 48 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start16 Sep 2019
- Primary completion7 Jul 2020
- Study completion7 Jul 2020
Why it stopped: Sponsor support and funding was terminated due to pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin to Twin Transfusion SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodrigo Ruano, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140669
- Sponsor's protocol ID
- 18-005189
- Status last verified
- Jul 2022
- First submitted
- 24 Oct 2019
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Myocardial Performance Index Before, During and After Fetal Surgeries Using Samsung HERA W10
- ClinicalTrials.gov ID
- NCT04140669
- Acronym / sponsor ID
- 18-005189
- Conditions
- Twin to Twin Transfusion Syndrome, Congenital Diaphragmatic Hernia, Neural Tube Defects, Lower Urinary Tract Infection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor support and funding was terminated due to pandemic
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fetal Surgery Procedures | – | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Fetal Surgery Procedures |
Primary outcome
Automated MPI can used to diagnosis and predict fetal cardiac dysfunction in fetal surgeries.
Time frame: 48 hours post-operatively
Results and safety
The study was stopped early (reason given: Sponsor support and funding was terminated due to pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Ruano, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Twin to Twin Transfusion Syndrome and Congenital Diaphragmatic Hernia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor support and funding was terminated due to pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Automated MPI can used to diagnosis and predict fetal cardiac dysfunction in fetal surgeries. (time frame: 48 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022; AzTrials last refreshed its copy on 31 Oct 2026.