Unique ID issued by UMIN | UMIN000043128 |
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Receipt number | R000049222 |
Scientific Title | Safety study of fetoscopic diagnosis and therapy for lower urinary tract obstruction (LUTO) |
Date of disclosure of the study information | 2021/01/25 |
Last modified on | 2023/01/26 23:04:28 |
Safety study of fetoscopic diagnosis and therapy for lower urinary tract obstruction (LUTO)
Safety study of fetoscopic diagnosis and therapy for lower urinary tract obstruction (LUTO)
Safety study of fetoscopic diagnosis and therapy for lower urinary tract obstruction (LUTO)
Safety study of fetoscopic diagnosis and therapy for lower urinary tract obstruction (LUTO)
Japan |
Fetal lower urinary tract obstruction
Obstetrics and Gynecology |
Others
NO
To assess feasibility and safety of fetoscopic diagnosis and therapy for lower urinary tract obstruction.
Safety
Others
Others
Not applicable
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
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
NO
NO
Institution is not considered as adjustment factor.
NO
1
Diagnosis
Maneuver |
Fetal diagnosis for lower urinary tract obstruction and fetal therapy for post urethral valve using fetoscopy.
20 | years-old | <= |
45 | years-old | > |
Female
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
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
10
1st name | Seiji |
Middle name | |
Last name | Wada |
National Center for Child Health and Development
Division of Fetal Medicine
157-8535
2-10-1 Okura, Setagaya, Tokyo 157-8535, Japan
0334160181
wada-s@ncchd.go.jp
1st name | Seiji |
Middle name | |
Last name | Wada |
National Center for Child Health and Development
Division of Fetal Medicine
157-8535
2-10-1 Okura, Setagaya, Tokyo 157-8535, Japan
0334160181
https://fetusjapan.jp/clinical/clinical-3135
wada-s@ncchd.go.jp
Division of Fetal Medicine, National Center for Child Health and Development
National Center for Child Health and Development
Other
Department of Obstetrics, Osaka Women's and Children's Hospital
Ethics committee in National Center for Child Health and Development
2-10-1 Okura, Setagaya, Tokyo 157-8535, Japan
0334160181
rinri@ncchd.go.jp
NO
国立成育医療研究センター(東京都)、大阪母子医療センター(大阪府)
2021 | Year | 01 | Month | 25 | Day |
Unpublished
Open public recruiting
2020 | Year | 03 | Month | 03 | Day |
2020 | Year | 04 | Month | 22 | Day |
2021 | Year | 01 | Month | 25 | Day |
2025 | Year | 09 | Month | 30 | Day |
2021 | Year | 01 | Month | 25 | Day |
2023 | Year | 01 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049222
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