UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024486 |
|---|---|
| Receipt number | R000028181 |
| Scientific Title | Study for diagnosis and management of insufficiency of fetal circulation in twin-to-twin transfusion syndrome |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2019/04/22 19:35:01 |
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Basic information
Public title
Study for diagnosis and management of insufficiency of fetal circulation in twin-to-twin transfusion syndrome
Acronym
Study for fetal circulatory insufficiency in TTTS
Scientific Title
Study for diagnosis and management of insufficiency of fetal circulation in twin-to-twin transfusion syndrome
Scientific Title:Acronym
Study for fetal circulatory insufficiency in TTTS
Region
| Japan |
Condition
Condition
twin-to-twin transfusion syndrome
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the optimal diagnostic methods for fetal circulatory disturbance in twin-to-twin transfusion syndrome
Basic objectives2
Others
Basic objectives -Others
To develop an useful clinical method
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ultrasound measurement for fetal circulatory disturbance
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
monochorionic pregnancies
Key exclusion criteria
not available for informed consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Nakata |
Organization
Toho University
Division name
Omari Medical Center
Zip code
143-8541
Address
6-11-1 Omari-Nishi Ota-ku, Tokyo
TEL
+81-3-3762-4151
masahiko.nakata@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Nakata |
Organization
Toho University Omari Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
143-8541
Address
6-11-1 Omari-Nishi Ota-ku, Tokyo
TEL
+81-3-3762-4151
Homepage URL
masahiko.nakata@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omari Medical Center
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
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
Toho University Omori Medical Center
Address
6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541
Tel
03-3762-4151
somu.omori@jim.toho-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 22 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 22 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 31 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2016 | Year | 10 | Month | 19 | Day |
Last modified on
| 2019 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028181
