UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006096 |
|---|---|
| Receipt number | R000006073 |
| Scientific Title | Analysis of Rho-associated kinase(ROCK) activity in human placenta and peripheral blood monocytes. |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2012/08/17 21:38:01 |
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Basic information
Public title
Analysis of Rho-associated kinase(ROCK) activity in human placenta and peripheral blood monocytes.
Acronym
Analysis of Rho-associated kinase(ROCK) activity in human placenta and peripheral blood monocyte.
Scientific Title
Analysis of Rho-associated kinase(ROCK) activity in human placenta and peripheral blood monocytes.
Scientific Title:Acronym
Analysis of Rho-associated kinase(ROCK) activity in human placenta and peripheral blood monocyte.
Region
| Japan |
Condition
Condition
pregnancy,pregnancy induced hypertension,intrauterin growth restriction
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determin the implication of ROCK activity in placenta and peripheral blood monocytes in the progression of placental dysfunction.
Basic objectives2
Others
Basic objectives -Others
To analyze the relation between ROCK activity in placenta and peripheral monocytes.To analyze the relation between ROCK activity and number of weeks of pregnancy or prognosis of pregnancy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ROCK activity,severity of PIH,HELLP syndrome,birth weignt,Apgar score,resistance index of umbilical artery and uterine artery,uric acid,platelet count
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
Pregnant women
Key exclusion criteria
Subjects without informed consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Kudo |
Organization
Hiroshima university
Division name
Department of obstetric and gynecology
Zip code
Address
1-2-3kasumi,minamiku,hiroshima
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohisa Sakashita |
Organization
Hiroshima university of biomedical science
Division name
Department of obstetrics and gynecology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of obstetrics and gynecology,Hiroshima university of biomedical science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education,Science and Culture
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
広島大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 01 | 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
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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
To analyze the relation between ROCK activity in placenta and peripheral monocytes.To analyze the relation between ROCK activity and number of weeks of pregnancy or prognosis of pregnancy.
Management information
Registered date
| 2011 | Year | 08 | Month | 01 | Day |
Last modified on
| 2012 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006073
