Clinical Trials

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.

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.

The purpose of the study is to investigate whether amnioinfusion intervention for fetuses diagnosed with intrauterine renal failure will be safe and feasible.

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.

The purpose of this study is to determine if it is possible to record a high quality fetal ECG using signals acquired inside of the birth canal (vagina). 

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.

The purpose of this study is to develop an unobtrusive means of acquiring the fetal electrocardiogram (fECG) during exercise to determine heart rate and to characterize fetal status (ST, T wave, and additional analysis) by means of an abdominal recording device. The device will be used to evaluate the safety of the fetus during exercise in order to develop medical guidelines for the higher limits of pregnant women during strenuous exercise.

The purpose of this study is to evaluate the outcomes of fetal aortic valvuloplasty performed in cases selected using a refined inclusion criteria (use the 2009 criteria) and exclude group/category (Friedman et al. 20182 – see section 3.3).  Left ventricle pressure ≤ 47 mmHg, MV dimension Z-score < 0.1="" and="" mv="" inflow="" time="" z-score="" />< _-229_.="" our="" hypothesis="" is="" that="" utilizing="" a="" refined="" selection="" criteria="" the="" outcomes="" can="" be="" further="" />

This study aims to determine the proportion of neonates surviving to successful dialysis after serial amnioinfusions (defined as use of a dialysis catheter for > 15 continuous days) and to determine the feasibility of serial amnioinfusions for early pregnancy renal anhydramnios (EPRA). It also aims to perform an exploratory study of the in utero natural history of untreated EPRA and to examine correlations between prenatal ultrasound, echocardiogram, MRI, and lung specific factors in amniotic fluid as predictive biomarkers of the success of RAFT for EPRA. Lastly, the study aims to determine the short term and long-term quality of life of patients and families that undergo RAFT.

The purpose of this study is to determine feasibility and safety of performing in utero surgery with the Karl Storz fetoscopes (11508AAK and 11506AAK). Additionally, to compare the gestational age at delivery of cases completed using the new generation fetoscopes (11508AAK and 11506AAK) with that of matched historical control group completed prior to the introduction of 11508AAK and 11506AAK fetoscopes.