UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008547 |
|---|---|
| Receipt number | R000006525 |
| Scientific Title | Progression of diabetic retinopathy during pregnancy |
| Date of disclosure of the study information | 2012/07/26 |
| Last modified on | 2012/11/18 16:36:49 |
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Basic information
Public title
Progression of diabetic retinopathy during pregnancy
Acronym
Pregnancy and diabetic retinopathy
Scientific Title
Progression of diabetic retinopathy during pregnancy
Scientific Title:Acronym
Pregnancy and diabetic retinopathy
Region
| Japan |
Condition
Condition
diabetic retinopathy
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the progression of diabetic retinopathy during pregnancy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
age, type of diabetes, duration of diabetes, HbA1c, visus, stage of diabetic retinopathy
Key secondary outcomes
height, weight, blood pressure, Cr, proteinuria
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with diabetes during/after pregnancy
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junko Toda |
Organization
Tokyo Women`s Medical University
Division name
Diabetes Center
Zip code
Address
kawada-cho 8-1, shinjuku-ku
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Toda |
Organization
Tokyo Women`s Medical University
Division name
kenkyushien-bu
Zip code
Address
kawada-cho 8-1, shinjuku-ku
TEL
03-3353-8112
Homepage URL
http://www.twmu.ac.jp/index.html
kshikin@ofc.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women`s Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women`s 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
東京女子医科大学病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 26 | Day |
Related information
URL releasing protocol
https://www.twmu.ac.jpindex.html
Publication of results
Published
Result
URL related to results and publications
https://www.twmu.ac.jpindex.html
Number of participants that the trial has enrolled
Results
unknown
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
| 2011 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
retrospective study
Management information
Registered date
| 2012 | Year | 07 | Month | 26 | Day |
Last modified on
| 2012 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006525
