UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062968 |
|---|---|
| Receipt number | R000069704 |
| Scientific Title | A Prospective Observational Study and Qualitative Investigation on the Effects of Shared Decision-Making Regarding Prenatal Diagnosis on the Relationship and Mental Health of Pregnant Couples and Healthcare Providers |
| Date of disclosure of the study information | 2026/09/17 |
| Last modified on | 2026/09/17 17:46:49 |
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Basic information
Public title
A Study on the Impact of the Relationship Between Couples and Healthcare Providers During Prenatal Diagnosis Counseling on Mental Health
Acronym
P-SHARE
Scientific Title
A Prospective Observational Study and Qualitative Investigation on the Effects of Shared Decision-Making Regarding Prenatal Diagnosis on the Relationship and Mental Health of Pregnant Couples and Healthcare Providers
Scientific Title:Acronym
Prenatal Shared decision making, Health, and Alliance REsearch (P-SHARE)
Region
| Japan |
Condition
Condition
pregnancy
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a program that facilitates decision-making support involving partners equally in prenatal diagnosis, verify its feasibility, and assess the effects of communication regarding sensitive topics on the relationship between couples and healthcare providers, as well as on the mental health of the couples.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Marital relationship
Key secondary outcomes
resilience, trust in healthcare, pregnancy-related anxiety, well-being, decisional conflict, shared decision-making
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Providing specific information and encouraging dialogue within the family can have an impact on the health of the study participants.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Pregnant women who have had a fetal heartbeat confirmed in the uterus by a physician at a participating research institution
2) Less than 15 weeks pregnant
3) Residing in Japan
4) Able to read, write, and understand everyday Japanese without difficulty
5) Scheduled to have their next prenatal checkup at the same facility as the recruitment site
Key exclusion criteria
1) Individuals with cognitive impairments or visual or hearing impairments
2) Individuals currently receiving outpatient treatment for a mental illness
3) Individuals who face difficulties using the Japanese language
4) Women without a partner or whose partner cannot be contacted
5) Individuals who have expressed refusal to allow their information to be used in this study
6) Individuals who do not intend to continue their pregnancy
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Okuhara |
Organization
School of Public Health, Graduate School of Medicine, The University of Tokyo
Division name
Department of Health Communication
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-Ku, Tokyo 113-8655, Japan
TEL
03-5800-6549
okuhara-ctr@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ritsuko |
| Middle name | |
| Last name | Shirabe |
Organization
the University of Tokyo Hospital
Division name
University hospital Medical Information Network (UMIN) Center
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-Ku, Tokyo 113-8655, Japan
TEL
03-5800-6549
Homepage URL
rshirabe-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
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
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
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 | 09 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 04 | 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 | 09 | Month | 17 | Day |
Last modified on
| 2026 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069704
