UMIN-CTR Clinical Trial

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
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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
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Results Delayed
Results Delay Reason
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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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