UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022473 |
|---|---|
| Receipt number | R000025896 |
| Scientific Title | The maternal outcome and perinatal outcomes in twin twin transfusion syndrome treated by fetoscopic laser surgery. |
| Date of disclosure of the study information | 2016/07/11 |
| Last modified on | 2018/03/17 11:47:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The maternal outcome and perinatal outcomes in twin twin transfusion syndrome treated by fetoscopic laser surgery.
Acronym
The outcomes in TTTS treated by FLP.
Scientific Title
The maternal outcome and perinatal outcomes in twin twin transfusion syndrome treated by fetoscopic laser surgery.
Scientific Title:Acronym
The outcomes in TTTS treated by FLP.
Region
| Japan |
Condition
Condition
twin twin transfusion syndrome
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
maternal outcome and perinatal outcomes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
maternal complications
delivery weeks
fetal outcomes
neonatal outcomes
neonatal complications
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
fetoscopic laser surgery
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
monochorionic diamniotic twin
twin twin transfusion syndrom
from 16 weeks of gestation
Key exclusion criteria
pregnnancy with HBV,HCV,HIV infection
preterm labor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Murata |
Organization
Kawasaki medical school
Division name
Obstetrics and Gynecology
Zip code
Address
577, Matsushima, Kurashiki city, Okayama
TEL
086-462-1111
smurata@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Susumu Murata |
Organization
Kawasaki Medical School
Division name
Obstetrics and Gynecology
Zip code
Address
577, Matsushima, Kurashiki city, Okayama
TEL
086-462-1111
Homepage URL
smurata@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki medical school
Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Kawasaki medical school
Obstetrics and Gynecology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 11 | 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
31 cases registrated in this study until March 16, 2018.
The outcome was similar to past reports.
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 26 | Day |
Last modified on
| 2018 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025896
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/05/29 | TTTS前方視敵検討研究実施計画書ver2.0.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
