Fetal lower urinary tract obstruction
Conditions
Interventions
Fetal diagnosis for lower urinary tract obstruction and fetal therapy for post urethral valve using fetoscopy.
Sponsors
Division of Fetal Medicine, National Center for Child Health and Development
Department of Obstetrics, Osaka Women'
s and Children'
s Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: For pregnant women 1. Between 16+0 weeks gestation and 25+6 weeks gestation 2. Singleton pregnancy 2. No severe complication 3. No rupture of membrane 4. Cervical length is above 25mm 5. Consent of a pregnant woman and her partner For fetus 1. Severe lower urinary tract obstruction (megacystis) 2. beta-2 microglobulin is lower than reference value (calculated by the formula: 13.45-0.493*[gestational weeks]+2.6*2) by urine examination 3. Reaccumulation after fetal bladder centesis
Exclusion criteria
Exclusion criteria: For regnant women 1. Infectious diseases required treatments 2. Positive results of HIV antibody, HCV antibody or HBe antigen 3. Severe psychological disorder 4. American Society of Anesthesiology (ASA) Physical Status Classification Class 3, 4, 5 or 6 5. Multiple pregnancy 6. Severe obesity (BMI >35) For fetus 1. Unilateral or bilateral cystic change of kidney by ultrasound 2. Severe associated anomaly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The rates of completing fetoscopic diagnosis for lower urinary tract obstruction without severe adverse events of pregnant women 2. The rates of completing fetoscopic therapy for post urethral valve | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The rate of agreement between prenatal diagnosis by fetoscopy and postnatal diagnosis 2. The rate of miscarriage and preterm delivery within 48 hours after fetoscopy 3. The rate of fetal demise within 48 hours after fetoscopy | — |
Countries
Japan
Contacts
Public ContactSeiji Wada
National Center for Child Health and Development Division of Fetal Medicine
Outcome results
None listed