UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective observational study of the development of retinopathy associated with pregnancy with impaired glucose tolerance in Japan using a medical fee claim database
Acronym	A retrospective observational study of the development of retinopathy associated with pregnancy with impaired glucose tolerance in Japan
Scientific Title	A retrospective observational study of the development of retinopathy associated with pregnancy with impaired glucose tolerance in Japan using a medical fee claim database
Scientific Title:Acronym	A retrospective observational study of the development of retinopathy associated with pregnancy with impaired glucose tolerance in Japan
Region	Japan

Condition
Condition	carbohydrate metabolic disorders duri ng pregnancy
Classification by specialty	Obsterics and gynecology Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To Understand the actual situation of t he progression of retinopathy in carbo hydrate metabolic disorders during pregnancyusing a medical fee claim database.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression of diabetic retinopathy
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	20 years-old <=
Age-upper limit	50 years-old >
Gender	Female
Key inclusion criteria	Pregnant female with carbohydrate metabolic disorders during pregnancy who received examination in gynecology and ophthalmology during 1/1/2013 to 31/12/2017
Key exclusion criteria	*) Patient with ocular disease except diabetic retinopathy, unstable general condition *)PI decide the patients as inappropriate.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Masahiko Middle name Last name Sugimoto
Organization	Mie University Graduate School of Medicine
Division name	Department of Ophthalmology
Zip code	514-8507
Address	2-174, Edobashi, Tsu, Mie, Japan
TEL	0592315027
Email	sugmochi@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	1st name Masahiko Middle name Last name Sugimoto
Organization	Mie University Graduate School of Medicine
Division name	Department of Ophthalmology
Zip code	514-8507
Address	2-174, Edobashi, Tsu, Mie, Japan
TEL	0592315027
Homepage URL
Email	sugmochi@clin.medic.mie-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Ophthalmology, Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Mie University Graduate School of Medicine
Address	2-174, Edobashi, Tsu, Mie, Japan
Tel	0592315027
Email	sugmochi@clin.medic.mie-u.ac.jp

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	2020 Year 02 Month 03 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	2020 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date	2020 Year 02 Month 03 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 02 Month 03 Day
Last modified on	2020 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044902