UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013963 |
|---|---|
| Receipt number | R000016266 |
| Scientific Title | The local injection treatment of methotrexate (MTX) for the placenta accreta |
| Date of disclosure of the study information | 2014/05/15 |
| Last modified on | 2016/05/16 13:48:50 |
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Basic information
Public title
The local injection treatment of methotrexate (MTX) for the placenta accreta
Acronym
MTX local injection for the placenta accreta
Scientific Title
The local injection treatment of methotrexate (MTX) for the placenta accreta
Scientific Title:Acronym
MTX local injection for the placenta accreta
Region
| Japan |
Condition
Condition
placenta accreta
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We clarify the safety and efficacy of MTX local injection treatment for placenta accreta.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduction of the blood loss during hepatectomy.
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
local injection treatment of MTX
Interventions/Control_2
control
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
The pregnancy women with placenta accreta
Key exclusion criteria
The pregnancy women with placenta accrete undergone cesarean delivery with hysterectomy.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mamoru Morikawa |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Obstetrics
Zip code
Address
Kita-ku N15 W7, Sapporo 060-8638, Japan
TEL
011-706-6051
mmamoru@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamoru Morikawa |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Obstetrics
Zip code
Address
Kita-ku N15 W7, Sapporo 060-8638, Japan
TEL
011-706-6051
Homepage URL
mmamoru@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Obstetrics,
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics,
Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 05 | Month | 15 | 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
| 2014 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 15 | Day |
Last modified on
| 2016 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016266
