Fetal Cystoscopy for Lower Urinary Tract Obstruction
Stopped: Original P.I. of this study transferred to a different institution.
United States8 participantsStarted 2014-12-04
Plain-language summary
This is a pilot study 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 the investigators clinical experience with fetal vesicoamniotic shunting.
Who can participate
Age range16 Weeks – 26 Weeks
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 r…