Clinical trials in fetal surgery - changing care for complex pregnancies

Abstract

Fetal therapy has continued to expand in treatable conditions and surgical approaches. To maintain the evidence-based approach to optimizing patient care and outcomes, clinical trials investigating these interventions is essential. All trials must take in consideration both the potential benefit to the fetus or fetuses with the maternal and perinatal risks. In this review we discuss clinical trials in fetal therapy which have changed the field and provided the highest level of evidence possible. Large-scale trials have been performed in the management of Twin-to-Twin Transfusion Syndrome (TTTS), Spina bifida, Lower Urinary Tract Obstruction (LUTO) and Congenital Diaphragmatic Hernia (CDH). As molecular biology and advanced prenatal diagnostics continues to develop, future trials in gene and enzyme therapy remain on the horizon.