Safety study of fetoscopic diagnosis and therapy for lower urinary tract obstruction (LUTO)
Not Applicable
Recruiting
- Conditions
- Fetal lower urinary tract obstruction
- Registration Number
- JPRN-UMIN000043128
- Lead Sponsor
- Division of Fetal Medicine, National Center for Child Health and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 10
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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