UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058519 |
|---|---|
| Receipt number | R000066914 |
| Scientific Title | A Preliminary Study of an Educational Intervention on the Impact of Sleep Improvement on Glucose Tolerance in Pregnant Women |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2025/07/18 17:54:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Preliminary Study of an Educational Intervention on the Impact of Sleep Improvement on Glucose Tolerance in Pregnant Women
Acronym
Pilot Study on Sleep and Glucose Tolerance in Pregnant Women
Scientific Title
A Preliminary Study of an Educational Intervention on the Impact of Sleep Improvement on Glucose Tolerance in Pregnant Women
Scientific Title:Acronym
Sleep Education for Glucose Tolerance in Pregnancy
Region
| Japan |
Condition
Condition
Impaired Glucose Tolerance
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the potential efficacy and safety of sleep improvement for pregnant women with poor sleep quality in improving glucose tolerance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c level at 4 weeks after the start of the intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Two online meetings and self-study within 4 weeks
Interventions/Control_2
No specific intervention will be implemented during the 4-week period.
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Ability to communicate in Japanese
Singleton pregnancy
Early pregnancy (first trimester)
Meeting at least one of the following criteria for high risk of impaired glucose tolerance in pregnancy:
a. Family history of diabetes (parents or siblings)
b. History of gestational diabetes mellitus
c. Obesity (BMI over 24)
d. Hypertension
Key exclusion criteria
Participation is deemed inadvisable by a physician due to the participant's physical or mental health condition.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Sakamoto |
Organization
Toho University
Division name
Faculty of Nursing
Zip code
143-0015
Address
4-16-20, Omori-Nishi, Ota
TEL
0337629881
naoko.sakamoto@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Sakamoto |
Organization
National Center for Child Health and Development
Division name
Perinatal and Maternal Medicine Center
Zip code
157-8535
Address
2-10-1, Okura, Setagaya
TEL
0334180181
Homepage URL
sakamoto-n@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Ethics Committee of the National Center for Child Health and Development
Address
2-10-1, Okura, Setagaya
Tel
0334180181
rinri@ncchd.go.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
| 2026 | Year | 03 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 18 | Day |
Last modified on
| 2025 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066914
