Few studies are specifically designed to address health concerns that are already relevant during pregnancy. The consequence is a lack of evidence on best clinical practice. This includes mothers and their babies when pregnancy is complicated by an abnormally slow heart rate due to maternal antibody-mediated heart disease in the unborn baby (fetus). Since the late seventies, it has been possible to detect and monitor fetal disease by ultrasound images and to treat selected conditions with pharmaceuticals administered via the mother. To this day, physicians need to make decisions about the management of such pregnancies without evidence from prospective clinical trials on drug efficacy and safety. The SLOW HEART REGISTRY is a multi-centered prospective observational study that will address the knowledge gap to guide future management of high-degree immune-mediated heart block to the best of care. The study seeks to establish an international database of the management and outcome of affected fetuses, to be used to publish information on the results of currently available prenatal care and to evaluate the need for additional research.
Heart Block Complete, Heart Block Second Degree
Few studies are specifically designed to address health concerns that are already relevant during pregnancy. The consequence is a lack of evidence on best clinical practice. This includes mothers and their babies when pregnancy is complicated by an abnormally slow heart rate due to maternal antibody-mediated heart disease in the unborn baby (fetus). Since the late seventies, it has been possible to detect and monitor fetal disease by ultrasound images and to treat selected conditions with pharmaceuticals administered via the mother. To this day, physicians need to make decisions about the management of such pregnancies without evidence from prospective clinical trials on drug efficacy and safety. The SLOW HEART REGISTRY is a multi-centered prospective observational study that will address the knowledge gap to guide future management of high-degree immune-mediated heart block to the best of care. The study seeks to establish an international database of the management and outcome of affected fetuses, to be used to publish information on the results of currently available prenatal care and to evaluate the need for additional research.
Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block
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Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016
University of California San Francisco, San Francisco, California, United States, 94143
Children's Hospital Colorado, Denver, Colorado, United States, 80205
Children's National Medical Center, Washington, District of Columbia, United States, 20010
Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States, 33701
Children's Mercy Kansas City, Kansas City, Kansas, United States, 64108
Boston Children's Hospital, Boston, Massachusetts, United States, 02115
The Children's Heart Clinic/Children's Minnesota, Minneapolis, Minnesota, United States, 55404
Columbia University (New York), New York, New York, United States, 10027
Texas Children's Hospital, Houston, Texas, United States, 77030
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
16 Years to 50 Years
FEMALE
No
The Hospital for Sick Children,
Edgar Jaeggi, MD, PRINCIPAL_INVESTIGATOR, The Hospital for Sick Children, Toronto
2029-12-31