Trials Sponsors Conditions Drugs Pricing

Conditions

Congenital Diaphragmatic Hernia Lower Urinary Tract Infection Neural Tube Defects Twin to Twin Transfusion Syndrome

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

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)

Interventions

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.

Fetal Surgery Procedures

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsParticipant eligibility is based on current pregnancy

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

Sponsors & Collaborators

Mayo Clinic
Otherlead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

MeSH Terms

Conditions

Fetofetal TransfusionHernias, Diaphragmatic, CongenitalNeural Tube Defects

Condition Hierarchy (Ancestors)

Anemia, NeonatalAnemiaHematologic DiseasesHemic and Lymphatic DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCongenital AbnormalitiesHernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

Rodrigo Ruano, MD, PhD
Mayo Clinic
PRINCIPAL INVESTIGATOR

Enrollment

7 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 24, 2019

First Posted

October 28, 2019

Study Start

September 16, 2019

Actual (reported)

Study Stopped

Automated Myocardial Performance Index Using Samsung HERA W10

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Fetal Surgery Procedures

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Fetal Surgery Procedures

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations