UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059364 |
|---|---|
| Receipt number | R000067896 |
| Scientific Title | Effectiveness of Providing Information on Preparing for Pregnancy and Having Children for Individuals with Spina Bifida |
| Date of disclosure of the study information | 2025/10/17 |
| Last modified on | 2025/10/10 12:05:07 |
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Basic information
Public title
Effectiveness of Providing Information on Preparing for Pregnancy and Having Children for Individuals with Spina Bifida
Acronym
Effectiveness of Providing Information on Preparing for Pregnancy for Individuals with Spina Bifida
Scientific Title
Effectiveness of Providing Information on Preparing for Pregnancy and Having Children for Individuals with Spina Bifida
Scientific Title:Acronym
Effectiveness of Providing Information on Preparing for Pregnancy for Individuals with Spina Bifida
Region
| Japan |
Condition
Condition
Spina bifida
Classification by specialty
| Obstetrics and Gynecology | Pediatrics | Orthopedics |
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of on-demand education for individuals with spina bifida regarding preparation for pregnancy and parenthood, and to gain insights into effective methods for providing information.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interest and actions regarding preconception care will be assessed before the intervention, two weeks after, one month after, and three months after.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will have the opportunity to view informational materials, including pamphlets or videos, that focus on preparing for pregnancy and having children. These materials will be available for a period of three months. Following a three-month hiatus, they will resume viewing or watching the other type of media they had not viewed or watched for the previous three months.
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals with spina bifida
Key exclusion criteria
Women who have experienced pregnancy, childbirth, infertility counseling, or infertility treatment, and men who currently have children and have experienced infertility counseling or infertility treatment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | KUMI |
| Middle name | |
| Last name | KASAI |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Nursing
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
TEL
029-888-4000
kasaik@ipu.ac.jp
Public contact
Name of contact person
| 1st name | KUMI |
| Middle name | |
| Last name | KASAI |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Nursing
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
TEL
029-888-4000
Homepage URL
kasaik@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ibaraki Prefectural University of Health Sciences Institutional Review Board
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
Tel
029-888-4000
kasaik@ipu.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
| 2025 | Year | 10 | Month | 17 | 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
| 2025 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 01 | 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 | 10 | Month | 10 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067896
