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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010784
Receipt No. R000012620
Scientific Title The association between neonatal hypoglycemia and glycemic control in pregnant women with diabetes mellitus
Date of disclosure of the study information 2013/05/23
Last modified on 2013/12/25

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Basic information
Public title The association between neonatal hypoglycemia and glycemic control in pregnant women with diabetes mellitus
Acronym The association between neonatal hypoglycemia and glycemic control in pregnant women with diabetes mellitus(Takatsuki Study)
Scientific Title The association between neonatal hypoglycemia and glycemic control in pregnant women with diabetes mellitus
Scientific Title:Acronym The association between neonatal hypoglycemia and glycemic control in pregnant women with diabetes mellitus(Takatsuki Study)
Region
Japan

Condition
Condition gestational diabetes mellitus, pregnancy with diabetes mellitus
Classification by specialty
Endocrinology and Metabolism Obsterics and gynecology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the association between neonatal hypoglycemia and glycemic control in pregnant women with diabetes mellitus
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes plasma glucose concentration, IRI, C-peptide,HbA1c, glycoalbumin, body weight, BMI, complication
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria patients with gestational diabetes mellitus or pre-existing diabetes mellitus and their child
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayumi Funabiki
Organization Takatsuki General Hospital
Division name Endocrinology and Metabolism
Zip code
Address 1-3-13, Kosobe-cho, Takatsuki, Osaka, Japan
TEL 072-681-3801
Email funabiki@ajk.takatsuki-hp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayumi Funabiki
Organization Takatsuki General Hospital
Division name Endocrinology and Metabolism
Zip code
Address 1-3-13, Kosobe-cho, Takatsuki, Osaka, Japan
TEL 072-681-3801
Homepage URL
Email funabiki@ajk.takatsuki-hp.or.jp

Sponsor
Institute Takatsuki General Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 05 Month 23 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 Enrolling by invitation
Date of protocol fixation
2012 Year 06 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2013 Year 05 Month 23 Day
Last modified on
2013 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012620

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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