UMIN-CTR Clinical Trial

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
Email	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
Email	konmai25@gmail.com

Sponsor
Institute	Yokohama City University 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 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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048343