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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000028217
Receipt No. 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

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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 Obsterics 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
Email 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
Email smurata@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Obstetrics and Gynecology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031338

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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