UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056731 |
|---|---|
| Receipt number | R000064824 |
| Scientific Title | Development and evaluation of a preventive intervention program for coparenting to pregnant couples |
| Date of disclosure of the study information | 2025/05/14 |
| Last modified on | 2025/05/15 12:41:48 |
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Basic information
Public title
Development and evaluation of a preventive intervention program for coparenting to pregnant couples
Acronym
Development and evaluation of a preventive intervention program for coparenting to pregnant couples
Scientific Title
Development and evaluation of a preventive intervention program for coparenting to pregnant couples
Scientific Title:Acronym
Development and evaluation of a preventive intervention program for coparenting to pregnant couples
Region
| Japan |
Condition
Condition
Pregnancy
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a preventive intervention program for pregnant couples to encourage coparenting after birth, and to evaluate its feasibility, acceptability and preliminary effect during pregnancy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship quality
Key secondary outcomes
Prenatal coparenting
Feasibility
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
Subjects will watch a video on coparenting and fill out a worksheet while discussing the topics presented in the video with the couple.
Interventions/Control_2
Usual care
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Pregnant couples with their first child at 22-27 weeks gestation
2) Both couples agree in writing (Study subjects are pregnant women.)
Key exclusion criteria
1) a fetal abnormality, an obstetric complication
2) either or both couple have mental illness or a pregnant woman with depressive symptoms (CES-D score of 16 or more)
3) an individualized support for DV between couples
4) a couple planning to separate for at least 3 months postpartum
5) cannot read or write Japanese
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yui |
| Middle name | |
| Last name | Masui |
Organization
University of Osaka
Division name
Division of Health Sciences, Graduate School of Medicine
Zip code
565-0871
Address
1-7, Yamadaoka, Suita-city, Osaka 565-0871, Japan
TEL
06-6879-2539
y.masui@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yui |
| Middle name | |
| Last name | Masui |
Organization
University of Osaka
Division name
Division of Health Sciences, Graduate School of Medicine
Zip code
565-0871
Address
1-7, Yamadaoka, Suita-city, Osaka 565-0871, Japan
TEL
06-6879-2539
Homepage URL
y.masui@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
University of Osaka
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (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
Ethics Review Board of Osaka University Hospital
Address
2-2, Yamadaoka, Suita-city, Osaka 565-0871, Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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 | 14 | 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
| 2025 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | 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 | 01 | Month | 16 | Day |
Last modified on
| 2025 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064824
