Fetal Cystoscopy for Lower Urinary Tract Obstruction
Urethral Obstruction
About this trial
This is an interventional treatment trial for Urethral Obstruction focused on measuring urethral obstruction, posterior urethral valves, lower urinary tract obstruction
Eligibility Criteria
Inclusion Criteria:
- Fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
- Oligohydramnios or Anhydramnios after 18 weeks
- "Favorable urine analysis after 18 weeks (urinary sodium is < 100mEq/L, chloride < 90mEq/L, osmolarity <200mOsm/L and β2-microglobulin <6mg/L 7)
- Absence of chromosomal abnormalities and associated anomalies (Normal karyotype by invasive testing (amniocentesis or CVS))
- Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks
Exclusion Criteria:
- Fetal anomaly unrelated to LUTO
- Congenital cardiac anomaly
- 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 - A body-mass index ≥ 35
- 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 a support person (ie. Spouse, partner, mother) available to support the patient for the duration of the pregnancy at Texas Children's Hospital/Ronald McDonald House
- Patient does not have healthy insurance to cover routine clinical care at Texas Children's Hospital 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 the 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.
Sites / Locations
- Texas Children's Hospital Pavilion for Women
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
No Intervention
Fetal cystoscopy
Vesicoamniotic shunt
No fetal intervention group
Fetal cystoscopy will be performed under maternal local anesthesia and fetal anesthesia. The dilated posterior urethra will be directly evaluated. Laser fulguration will be performed in case of posterior urethral valves. However, if a non membrane-like structure is found, even with the fluid injection or the guide-wire, urethral atresia (UA, US or Prune Belly syndrome) will be diagnosed and we will not attempt to perforate this structure. A vesicoamniotic shunting placement will be performed in this situation depending on the patient's consent prior to the surgery.
The fetal vesicoamniotic shunt is considered the standard prenatal therapy for severe LUTO. Amnioinfusion and vesicoamniotic shunt placement will be performed under ultrasound guidance.
Those patients that refuse fetal intervention and do not elect to terminate the pregnancy will be followed as part of the no fetal intervention group.