UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042345 |
|---|---|
| Receipt number | R000048343 |
| Scientific Title | A study of the characteristics of twin gestational diabetes mellitus |
| Date of disclosure of the study information | 2020/11/04 |
| Last modified on | 2020/11/04 17:02:34 |
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Basic information
Public title
A study of the characteristics of twin gestational diabetes mellitus
Acronym
A study of the characteristics of twin gestational diabetes mellitus
Scientific Title
A study of the characteristics of twin gestational diabetes mellitus
Scientific Title:Acronym
A study of the characteristics of twin gestational diabetes mellitus
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 GDM in Japanese twin pregnancies, pregnancy and delivery outcomes, and the clinical course of GDM
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to investigate the course and delivery outcome of gestational diabetes in twin mothers managed at a single perinatal center in Japan, and to compare them with twin mothers diagnosed with non-GDM and single GDM pregnant women at the same time, in order to elucidate the risk factors for GDM, gestational delivery outcome, and clinical course of GDM in twin pregnancies in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the risk factors for GDM
pregnancy and delivery outcomes
the clinical course of GDM
Key secondary outcomes
1) Patient's basic information: age, BMI, weight, and previous pregnancy
2) Gestational history of pregnancy and delivery: 50 g GCT results, 75 g OGTT results, membranous diagnosis, weight gain, number of days in pregnancy, maternal perinatal complications
3) Clinical information on the child: sex, child weight, neonatal pseudomortality, and Apgar score
4) Placenta findings: placenta weight
5) Treatment: insulin unit count
6) Postpartum information: postpartum 75gOGTT results
7) Patient's medical record information: history of gestational diabetes, history of giant birth, history of congenital anomalies, history of preterm birth, PCOS, family history of diabetes, history of miscarriage (SA), history of abortion (KA), history of infertility treatment, blood pressure, smoking history, history of alcohol consumption.
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 gave birth after 22 weeks and 0 days of gestation between January 1, 2011 and December 31, 2016 at the Yokohama City University General Medical Center for Maternal and Child Health, and who were registered in the Maternity Registration Database, who had (1) twin pregnancies or (2) singleton and gestational diabetes mellitus.
Key exclusion criteria
No selection or exclusion criteria were established for case selection.
Target sample size
1194
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Yamakawa |
Organization
Yokohama City University Medical Center
Division name
Department of endocrinology & metabolism
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Kanagawa
TEL
045-261-5656
yamakat@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Sugiyama |
Organization
Yokohama City University Medical Center
Division name
Department of endocrinology & metabolism
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Kanagawa
TEL
045-261-5656
Homepage URL
konmai25@gmail.com
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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 City University Hospital, a public university Center for Advanced Medical Sciences, 5th Floor, P504 Clinical Trial Management Office
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City
Tel
0457872714
chiken@yokohama-cu.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 | 11 | Month | 04 | 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
1194
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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 04 | 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 treatment of twin gestational diabetes mellitus.
Management information
Registered date
| 2020 | Year | 11 | Month | 04 | Day |
Last modified on
| 2020 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048343
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
