UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057471 |
|---|---|
| Receipt number | R000065667 |
| Scientific Title | Development and Validation of a Preconception Care Program for Women with Mental Health Conditions: Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2026/04/06 20:47:27 |
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Basic information
Public title
Study on Preconception Care for Women with Mental Health Conditions
Acronym
Study on Preconception Care for Mental Health Conditions
Scientific Title
Development and Validation of a Preconception Care Program for Women with Mental Health Conditions: Randomized Controlled Trial
Scientific Title:Acronym
Randomized Controlled Trial of Preconception Care for Mental Health Conditions
Region
| Japan |
Condition
Condition
Mental Health Conditions
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop a preconception care program for women with mental health conditions to support them in preparing for pregnancy with a sense of security, and to evaluate the effectiveness of the program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Decisional Conflict Scale (DCS) scores from pre-intervention (T1) to post-intervention (T2) among participants
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Preconception care
Interventions/Control_2
Control
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
Male and Female
Key inclusion criteria
(1) Currently receiving treatment at a psychiatric or psychosomatic medicine clinic and have been diagnosed with a mental illness (any mental disorder)
(2) Are considering pregnancy
(3) Are able to watch videos and complete surveys via an internet connection
(4) Are 18 years of age or older
(5) Can provide informed consent
(6) Have obtained approval to participate in the study from the attending physician currently treating you
Key exclusion criteria
Patients with unstable mental status such as suicidal thoughts or imminent suicide attempts.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Tomita |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7262
saya.kikuchi.c5@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Saya |
| Middle name | |
| Last name | Kikuchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7262
Homepage URL
saya.kikuchi.c5@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
ec-med@grp.tohoku.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 | 05 | Month | 01 | 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 | 04 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 03 | Month | 31 | Day |
Last modified on
| 2026 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065667
