UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043128 |
|---|---|
| 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 | 2024/11/23 08:42:36 |
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Basic information
Public title
Safety study of fetoscopic diagnosis and therapy for lower urinary tract obstruction (LUTO)
Acronym
Safety study of fetoscopic diagnosis and therapy for lower urinary tract obstruction (LUTO)
Scientific Title
Safety study of fetoscopic diagnosis and therapy for lower urinary tract obstruction (LUTO)
Scientific Title:Acronym
Safety study of fetoscopic diagnosis and therapy for lower urinary tract obstruction (LUTO)
Region
| Japan |
Condition
Condition
Fetal lower urinary tract obstruction
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess feasibility and safety of fetoscopic diagnosis and therapy for lower urinary tract obstruction.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Fetal diagnosis for lower urinary tract obstruction and fetal therapy for post urethral valve using fetoscopy.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Female
Key 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
Key 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
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Wada |
Organization
National Center for Child Health and Development
Division name
Division of Fetal Medicine
Zip code
157-8535
Address
2-10-1 Okura, Setagaya, Tokyo 157-8535, Japan
TEL
0334160181
wada-s@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Wada |
Organization
National Center for Child Health and Development
Division name
Division of Fetal Medicine
Zip code
157-8535
Address
2-10-1 Okura, Setagaya, Tokyo 157-8535, Japan
TEL
0334160181
Homepage URL
https://fetusjapan.jp/clinical/clinical-3135
wada-s@ncchd.go.jp
Sponsor or person
Institute
Division of Fetal Medicine, National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
National Center for Child Health and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Obstetrics, Osaka Women's and Children's Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee in National Center for Child Health and Development
Address
2-10-1 Okura, Setagaya, Tokyo 157-8535, Japan
Tel
0334160181
rinri@ncchd.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
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）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049222
