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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042930
Receipt No. R000048353
Scientific Title Association between fasting time in pregnant women and hypoglycemia in neonates: A prospective cohort study
Date of disclosure of the study information 2021/02/20
Last modified on 2021/01/06

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Basic information
Public title A study to investigate the association between fasting time in pregnant women and hypoglycemia in neonates: A prospective cohort study
Acronym Fasting time and hypoglycemia in neonates study
Scientific Title Association between fasting time in pregnant women and hypoglycemia in neonates: A prospective cohort study
Scientific Title:Acronym A Study on Fasting Time and hypoglycemia in neonates
Region
Japan

Condition
Condition Blood glucose levels in neonates
Classification by specialty
Obsterics and gynecology Pediatrics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate whether hypoglycemia in neonates is more likely to occur when pregnant women fast for a longer time before delivery than a shorter time.
Basic objectives2 Others
Basic objectives -Others Prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of hypoglycemia in neonates
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
18 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Pregnant women delivering at the facility and neonates born by the women
Key exclusion criteria 1.Pregnant women with type 1 diabetes
2.Congenital disorders of carbohydrates, metabolism, and hormones in neonates
3.Died at birth
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name Taku
Middle name
Last name Iwami
Organization Kyoto University
Division name Kyoto University Health Service
Zip code 6068501
Address Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL 075-753-2404
Email iwami.taku.8w@kyoto-u.ac.jp

Public contact
Name of contact person
1st name Yuto
Middle name
Last name Makino
Organization Graduate School of Medicine and Faculty of Medicine Kyoto University
Division name Department of Preventive Service
Zip code 6068501
Address Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL 075-753-2404
Homepage URL
Email makino.yuto.83n@st.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Health Service
Institute
Department

Funding Source
Organization Kyoto University Health Service
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 Kyoto University Graduate school and Faculty of Medicine, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.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
2021 Year 02 Month 20 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 12 Month 16 Day
Date of IRB
Anticipated trial start date
2021 Year 02 Month 25 Day
Last follow-up date
2024 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The study design is a prospective cohort study.
Blood glucose will be measured immediately after birth in neonates as the primary outcome.
The enrollment period for the study subjects is from after the approval of the Ethics Committee to April 30, 2022. If the target sample size is reached during the study, enrollment will be suspended. We will also consider extending the enrollment period if the number of outcomes is low.
The observation period will be from the date of registration to the first blood glucose test after delivery. The observation period for those scheduled for outpatient visits up to 2 years of age after birth will be up to 2 years up to that point.

Management information
Registered date
2021 Year 01 Month 06 Day
Last modified on
2021 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048353

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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