Fetal cystoscopy for severe lower urinary tract obstruction in the fetus

You may qualify if

• Pregnant women
• Singleton pregnancy
• Maternal age ≥ 18 years
• Male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
• Oligohydramnios or Anhydramnios
• Favorable urine analysis defined as urinary sodium is < 100 milliequivalents per liter (mEq/L), chloride < 90 mEq/L, and osmolality < 200 milliosmoles per kilogram (mOsm/kg) after 20 weeks and in the absence of previous in utero intervention for the disease (vesicoamniotic shunt placement or fetal cystoscopy).
• Absence of chromosomal abnormalities and associated anomalies
• Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks
• Normal karyotype by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). Patients declining invasive testing will be excluded.
• Family have considered and declined the option of termination of the pregnancy at less than 24 weeks.
• Family meets psychosocial criteria, including sufficient social support and ability to understand requirements of the study.
• Parents or guardian are willing to provide signed informed consent.

You can't join if

• Fetal anomaly unrelated to LUTO
• Congenital cardiac anomaly
• Female fetus
• Increased risk for preterm labor including short cervical length (<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth
• Placental abnormalities (previa, abruption, accreta) known at time of enrollment
• Contraindications to surgery including previous hysterotomy in active uterine segment
• Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy
• Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
• Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
• Maternal medical condition that is a contraindication to surgery or anesthesia
• Patient does not have health insurance to cover routine clinical care including prenatal care, prenatal ultrasound, amniocentesis, tocolysis, admission, delivery, and fetal vesico-amniotic shunting. The exception will be fetal cystoscopy which is considered an experimental procedure.
• Inability to comply with travel and follow-up requirements of the trial
• Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
• Patients declining invasive testing
• Family does not meet psychosocial criteria including insufficient