UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062562 |
|---|---|
| Receipt number | R000070719 |
| Scientific Title | Effects of Parenting Guidance for Pregnant Women on Infant Head Turn Preference and Plagiocephaly |
| Date of disclosure of the study information | 2026/08/12 |
| Last modified on | 2026/08/12 15:05:15 |
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Basic information
Public title
Effects of Parenting Guidance for Pregnant Women on Infant Head Turn Preference and Head Shape
Acronym
Effects of Parenting Guidance for Pregnant Women on Infant Head Turn Preference and Head Shape
Scientific Title
Effects of Parenting Guidance for Pregnant Women on Infant Head Turn Preference and Plagiocephaly
Scientific Title:Acronym
Effects of Parenting Guidance for Pregnant Women on Infant Head Turn Preference and Plagiocephaly
Region
| Japan |
Condition
Condition
plagiocephaly
Classification by specialty
| Orthopedics | Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of parental guidance provided to mothers during pregnancy on the degree of head turn preference and plagiocephaly in infants at 1 and 3 months of age.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cranial asymmetry (CA)
Key secondary outcomes
cephalic index (CI), gross motor development, head control while lying on the stomach, acetabular development, head turn preference, asymmetrical posture, and parental caregiving behaviors
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the intervention group, researchers will provide guidance before delivery on methods to address the infant's head turn preference, the appropriate frequency of intervention, and safety precautions. In addition, researchers will ask them to keep a record of the time spent on daily exercises to address head turn preference, using an app or a diary book.
Interventions/Control_2
Participants in the control group will not receive prenatal guidance. At the conclusion of the 3-month measurements, they will be given the informational materials distributed to participants in the intervention group.
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
1) Women with a singleton pregnancy between 28 weeks 0 days and 36 weeks 6 days at the time of study enrollment
2) Individuals who reside or will be staying within approximately one hour's travel time (one way) from the University of Tokyo's Hongo Campus and have no plans to move outside this area by the end of the follow-up period
3) Individuals who consent to home visits by researchers for data collection or who are able to visit a laboratory on the Hongo Campus
4) Women who are pregnant with their first child
Key exclusion criteria
1) Individuals who have difficulty speaking, reading, or writing in Japanese
2) Individuals whose fetus is found to have a clear, severe congenital anomaly
3) Women with multiple pregnancies
4) Individuals whom their attending physician has determined are unsuitable for participation in this study
5) Individuals whose child is of a race other than Japanese
Target sample size
112
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Yoshioka-Maeda |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Community Health Nursing/Public Health Nursing, Division of Health Sciences & Nursing
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3597
kyokoy-tky@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Tatsui |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Graduate School of Medicine, The University of Tokyo
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3597
Homepage URL
tatsui-kana@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Department of Community Health Nursing/Public Health Nursing,
Division of Health Sciences & Nursing,
Graduate School of Medicine, The University of Tokyo
IRB Contact (For public release)
Organization
Research ethics committee, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokto.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
| 2026 | Year | 08 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2026 | Year | 08 | Month | 12 | Day |
Last modified on
| 2026 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070719
