UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042930 |
|---|---|
| Receipt number | 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 | 2025/02/21 20:34:12 |
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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
| Obstetrics 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
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
makino.yuto.83n@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Health Service
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
696
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
| 2020 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 11 | 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
| 2025 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048353
