UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062665 |
|---|---|
| Receipt number | R000071740 |
| Scientific Title | Evaluation of a Prevention Education Program for Developmental Dysplasia of the Hip: A Pilot Study |
| Date of disclosure of the study information | 2026/08/24 |
| Last modified on | 2026/08/24 13:12:09 |
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Basic information
Public title
Research on Infant Hip Health and Parenting
Acronym
Research on Infant Hip Health and Parenting
Scientific Title
Evaluation of a Prevention Education Program for Developmental Dysplasia of the Hip: A Pilot Study
Scientific Title:Acronym
Evaluation of a Prevention Education Program for Developmental Dysplasia of the Hip: A Pilot Study
Region
| Japan |
Condition
Condition
Developmental dysplasia of the hip
Classification by specialty
| Pediatrics | Orthopedics | Nursing |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To provide face-to-face developmental dysplasia of hip (DDH) prevention education to pregnant women and to examine the effectiveness, acceptability, and feasibility of the education program by assessing changes in behavior, intention, knowledge, attitude, and self-efficacy during pregnancy and after childbirth.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of DDH preventive behaviors (Period: 1 to 2 months postpartum)
Key secondary outcomes
Behavioral intention, knowledge, attitude, and self-efficacy about DDH prevention
Subject evaluation of program acceptability
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
face-to-face education on DDH prevention (approximately 60 min)
Interventions/Control_2
No treatment
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
1. Pregnant women who are between 22 weeks 0 days and 36 weeks 6 days of gestation on the date of the educational program or the corresponding reference date
2. Women who are pregnant with their first child
3. Women aged 18 years or older
4. Women who are able to read, write, and understand Japanese
If the target sample size cannot be achieved, the criterion requiring participants to be pregnant with their first child may be removed.
Key exclusion criteria
1. Women with multiple pregnancies
2. Women with diseases or disabilities that may make participation in the study difficult (e.g. severe mental disorders, visual or hearing impairments)
3. Women with high-risk pregnancies (e.g. placenta previa, hypertensive disorders of pregnancy, fetal growth restriction)
4. Women whose fetus has been identified by a physician as having a congenital condition (e.g. congenital heart disease, cleft lip and palate, Down syndrome)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Yoshioka-Maeda |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
1130033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358413597
faculty_chiiki-group@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Fumiyuki |
| Middle name | |
| Last name | Tanaka |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
1130033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358413597
Homepage URL
fumiyukitanaka@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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 | 24 | 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
| 2026 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2027 | 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 | 24 | Day |
Last modified on
| 2026 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071740
