UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042832
Receipt No. R000048874
Scientific Title Predictive factors during the postpartum period for glucose intolerance in women with gestational diabetes.
Date of disclosure of the study information 2020/12/25
Last modified on 2020/12/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Predictive factors during the postpartum period for glucose intolerance in women with gestational diabetes.
Acronym Predictive factors during the postpartum period for glucose intolerance in women with gestational diabetes.
Scientific Title Predictive factors during the postpartum period for glucose intolerance in women with gestational diabetes.
Scientific Title:Acronym Predictive factors during the postpartum period for glucose intolerance in women with gestational diabetes.
Region
Japan

Condition
Condition Gestational diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the risk factors for glucose intolerance in women with GDM.
Basic objectives2 Others
Basic objectives -Others The purpose of this study was to investigate the predictive factor during the postpartum period for glucose intolerance in women with GDM at a singles perinatal center in Japan by comparing the various factors between the patients with normal glucose tolerance and glucose intolerance.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The risk factors for glucose intolerance in women with GDM during the postpartum period
Key secondary outcomes 1) Patient's basic information: age, pre-pregnancy BMI, and previous pregnancy
2) Gestational history of pregnancy and delivery: 75 g OGTT results, weight gain, number of days in pregnancy, maternal perinatal complications
3) Clinical information on the child: child weight, neonatal complications, and Apgar score
4) Treatment: insulin unit count
5) Postpartum information: postpartum 75gOGTT results
6) Patient's medical record information: Family history of diabetes

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 who were diagnosed with GDM between January 1 2015 and May 31 2020 at Yokohama Medical Center, and who had glucose tolerance test within postpartum period.
Key exclusion criteria Patients were excluded if they had; no measurement for insulin at the postpartum OGTT, been treated with steroid, or overt diabetes.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Kazuki
Middle name
Last name Tajima
Organization Yokohama Medical Center
Division name Department of endocrinology & metabolism
Zip code 245-8575
Address 3-60-2 Harajuku, Totsuka-ku, Yokohama
TEL 045-851-2621
Email tajima.kazuki.jn@mail.hosp.go.jp

Public contact
Name of contact person
1st name Kazuki
Middle name
Last name Tajima
Organization Yokohama Medical Center
Division name Department of endocrinology & metabolism
Zip code 245-8575
Address 3-60-2 Harajuku, Totsuka-ku, Yokohama
TEL 045-851-2621
Homepage URL
Email tajima.kazuki.jn@mail.hosp.go.jp

Sponsor
Institute Yokohama Medical Center
Institute
Department

Funding Source
Organization This research will be funded by the basic research funds of the department to which the principal investigator belongs.
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 Yokohama Medical Center, Clinical Trial Management Office
Address 3-60-2 Harajuku, Totsuka-ku, Yokohama
Tel 045-851-2621
Email 700-kenkyu@mail.hosp.go.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 12 Month 25 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 09 Month 02 Day
Date of IRB
2020 Year 09 Month 02 Day
Anticipated trial start date
2020 Year 12 Month 26 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a retrospective observational study using existing medical record information from routine practice, and no burden or risk is expected to arise from participation in this study. The results of the study may be beneficial for future advances in the management of gestational diabetes mellitus.

Management information
Registered date
2020 Year 12 Month 24 Day
Last modified on
2020 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048874

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.