UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017052 |
|---|---|
| Receipt number | R000019765 |
| Scientific Title | Analysis of resting-state brain network in Pre-eclamptic patients |
| Date of disclosure of the study information | 2015/04/10 |
| Last modified on | 2016/08/12 13:20:03 |
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Basic information
Public title
Analysis of resting-state brain network in Pre-eclamptic patients
Acronym
Analysis of resting-state brain network in Pre-eclamptic patients
Scientific Title
Analysis of resting-state brain network in Pre-eclamptic patients
Scientific Title:Acronym
Analysis of resting-state brain network in Pre-eclamptic patients
Region
| Japan |
Condition
Condition
Pre-eclampsia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploration of brain networks in pre-eclamptic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A change of brain network according to the severity of pre-eclampsia
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
| 19 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
Pre-eclampsia
normal pregnancy
Key exclusion criteria
Patients who did not agree to participate this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromichi Kurosaki |
Organization
Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
Address
811-1, Kimiidera, Wakayama-city
TEL
073-441-0611
kurosaki@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Kurosaki |
Organization
Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
Address
811-1, Kimiidera, Wakayama-city
TEL
073-441-0611
Homepage URL
kurosaki@wakayama-med.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical 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 | 04 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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
We observed a significant change of brain network in pre-eclampsia patients group.
Management information
Registered date
| 2015 | Year | 04 | Month | 06 | Day |
Last modified on
| 2016 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019765
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
