UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016898 |
|---|---|
| Receipt number | R000019613 |
| Scientific Title | Intrauterine fetal blood transfusion for fetal anemia |
| Date of disclosure of the study information | 2015/03/24 |
| Last modified on | 2017/03/27 13:46:05 |
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Basic information
Public title
Intrauterine fetal blood transfusion for fetal anemia
Acronym
fetal blood transfusion
Scientific Title
Intrauterine fetal blood transfusion for fetal anemia
Scientific Title:Acronym
fetal blood transfusion
Region
| Japan |
Condition
Condition
fetal anemia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intrauterine fetal therapy for fetal anemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of the fetal anemia
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Puncture
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Fetal anemia
Key exclusion criteria
The fetus has a severe congenital abnormalities.
The patient does not agree with this therapy.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TSUDA HIROYUKI |
Organization
Nagoya University
Division name
Obstetrics and Gynecology
Zip code
Address
Tsurumai-cho 65, Showa-ku, Nagoya
TEL
052-744-2261
hiro-t@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TSUDA HIROYUKI |
Organization
Nagoya University
Division name
Obstetrics and Gynecology
Zip code
Address
Tsurumai-cho 65, Showa-ku, Nagoya
TEL
052-744-2261
Homepage URL
hiro-t@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2015 | Year | 03 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 27 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 27 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 27 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 24 | Day |
Last modified on
| 2017 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019613
