UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028217 |
|---|---|
| Receipt number | R000031338 |
| Scientific Title | The study of ultrasound findings and biochemical markers for the predicting congenital heart failure in recipients' infant in twin twin transfusion syndrome. |
| Date of disclosure of the study information | 2017/07/13 |
| Last modified on | 2018/03/16 18:23:03 |
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Basic information
Public title
The study of ultrasound findings and biochemical markers for the predicting congenital heart failure in recipients' infant in twin twin transfusion syndrome.
Acronym
ultrasound and biochemical marker in twin twin transfusion syndrome.
Scientific Title
The study of ultrasound findings and biochemical markers for the predicting congenital heart failure in recipients' infant in twin twin transfusion syndrome.
Scientific Title:Acronym
ultrasound and biochemical marker in twin twin transfusion syndrome.
Region
| Japan |
Condition
Condition
pregnant women, twin twin transfusion syndrome
Classification by specialty
| Cardiology | Obstetrics and Gynecology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Detecting the ultrasound and biochemical markers for the predicting a heart failure in recipients' fetus in twin twin transfusion syndrome.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between recipients'heart failure and ultrasound and biochemical markers in twin twin transfusion syndrome.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
fetoscopic laser photocoagulation in twin twin transfusion syndrome
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
| 16 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
The pregnant women will undergo laser photocoagulation therapy in twin twin transfusion syndrome.
Key exclusion criteria
severe fetal anomaly
Target sample size
50
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, 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, 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
Japan society for promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 07 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 03 | Month | 16 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 13 | Day |
Last modified on
| 2018 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031338
