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Clinical Studies


  • Automated Myocardial Performance Index Before, During and After Fetal Surgeries using Samsung HERA W10 Rochester, Minn.

    The purpose of this study is to evaluate the cardiac function in fetuses with specific conditions before, during, and after fetal interventions using an automated myocardial performance index.

  • Learning from Fetal DNA Sequences to Build Immune-Stimulatory Oligonucleotides Rochester, Minn.

    The purpose of this study is to learn about the ability of fetal DNA to activate the immune system.

  • Maternal-fetal Immune Responses to Fetal Surgery Rochester, Minn.

    The purposes of this study are to determine whether maternal T cells are activated and expand after in utero intervention, and to determine whether placental macrophages and histology in the maternal-fetal interface exhibit increased activation and inflammation in surgical cases born preterm (<37 weeks) compared to term.

  • Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study Rochester, Minn.

    The purpose of this study is to evaluate a new, minimally-invasive technique (fetoscopic repair) for repair of spina bifida (MMC) during the second trimester of pregnancy. Researchers are trying to determine if this less invasive surgical approach will have less risk to the mother and, at the same time, adequate closure of the fetal spina bifida defect.

  • North American Fetal Therapy Network Fetal Myelomeningocele Repair Registry Rochester, Minn.

    The purpose of this study is to form a registry of data on the long term physical and mental health outcomes of the mother and child following fetal surgical repair for spina bifida.

  • Pilot Trial of Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) at Mayo Clinic Rochester, Minn.

    Subjects to be enrolled in this study are pregnant women whose unborn baby has been diagnosed with severe congenital diaphragmatic hernia (CDH). CDH is a birth defect occurring early in pregnancy. It is characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, the intestines and other organs in the baby's abdomen can move into the chest and press on the developing lungs. CDH is a serious condition which prevents the fetal lungs from developing normally. The purpose of this study is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO). FETO involves two surgical procedures while the mother is still pregnant. During the early third trimester of pregnancy, a special tiny balloon is placed in the baby's trachea. After the balloon has been in place for several weeks, the balloon will be removed during a second procedure, generally done when the baby has reached about 34 weeks gestation. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe CDH. If better lung development can be promoted, it is expected that overall survival of babies with severe CDH after birth will also be improved.

  • Predicting Placental Pathologies by Ultrasound Imaging of the Human Placenta During Gestation Rochester, Minn.

    The purpose of this study is to develop an ultrasound method to identify villitis of unknown etiology (VUE)-induced inflammation in the human placenta during gestation. 

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  • Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial (LUTO) Rochester, Minn.

    This is a pilot study to evaluate the safety, feasibility and effectiveness of fetal cystoscopy in the prenatal diagnosis and therapy of fetuses with bladder outlet obstruction. Fetal bladder outlet obstruction is a rare congenital anomaly with severe consequences to the fetus. Because of the bladder outlet obstruction, amniotic fluid is diminished, drastically leading to abnormal development of the fetal lungs. In addition, the obstruction leads to significant kidney damage, including development of end stage renal disease. Fetal vesicoamniotic shunting is the clinical therapeutic option for these fetuses. However, the shunt has many complications including blockage and dislodgement. Fetal cystoscopy has been proposed as an alternative treatment with potential advantages over the shunt by allowing the correct prenatal diagnosis and specific treatment. Initial clinical trials have demonstrated favorable outcomes. The purpose of the study is to study the outcomes of maternal and fetal patients who are undergoing fetal intervention for severe, isolated lower urinary tract obstruction (LUTO) at Mayo Clinic in Rochester, Minnesota. The objectives are to evaluate the safety, feasibility, and effectiveness of fetal cystoscopy as an experimental procedure in avoiding perinatal death and renal impairment and to compare to our clinical experience with fetal vesico-amniotic shunting.

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