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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030231
Receipt No. R000034519
Scientific Title Phase2 study on the validity of initiating treatment during midtrimester for GDM patients
Date of disclosure of the study information 2017/12/05
Last modified on 2017/12/03

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Basic information
Public title Phase2 study on the validity of initiating treatment during midtrimester for GDM patients
Acronym GDM intervention trial
Scientific Title Phase2 study on the validity of initiating treatment during midtrimester for GDM patients
Scientific Title:Acronym GDM intervention trial
Region
Japan

Condition
Condition GDM
Classification by specialty
Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To validiate timing of treatment for GDM patients
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes large for gestational age(%)
Key secondary outcomes Incidence of macrosomia
SGA
shoulder dystocia
GDM associated neonatal complications

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Treatment timing for GDM patients
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 early onset mild GDM
Key exclusion criteria overt DM
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Aoki
Organization Yokohama City University Medical Center
Division name Perinatal Center for Maternity and Neonate
Zip code
Address 4-57 Urafunecho, Minami-ku, Yokahama City
TEL 045-261-5656
Email smyyaoki@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Aoki
Organization Yokohama City University Medical Center
Division name Perinatal Center for Maternity and Neonate
Zip code
Address 4-57 Urafunecho, Minami-ku, Yokahama City
TEL 045-261-5656
Homepage URL
Email smyyaoki@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
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
Email

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
2017 Year 12 Month 05 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
2017 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 01 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
2017 Year 12 Month 03 Day
Last modified on
2017 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034519

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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