UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021980 |
|---|---|
| Receipt number | R000025279 |
| Scientific Title | Study on development of coparenting intervention program for Japanese couple during pregnancy |
| Date of disclosure of the study information | 2016/06/02 |
| Last modified on | 2018/04/24 10:19:58 |
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Basic information
Public title
Study on development of coparenting intervention program for Japanese couple during pregnancy
Acronym
Study on development of coparenting intervention program during pregnancy
Scientific Title
Study on development of coparenting intervention program for Japanese couple during pregnancy
Scientific Title:Acronym
Study on development of coparenting intervention program during pregnancy
Region
| Japan |
Condition
Condition
pregnancy
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of coparenting intervention program during pregnancy for Japanese couple who is expected to have a first child
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
High score of Coparenting relationship Scale 1month and 3 months after having a first child
Key secondary outcomes
Marital Love, Marital Adjustment, Prenatal Comfort, Depression, parent to infant bonding
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
Intervention Group
4 session of antenatal intervention program based on Family Foundation Program(R)
Managed by midwives who are trained and have more than 3 years clinical experience.
1st [Building a family]
2nd [Feelings & conflict]
3rd [Teamwork]
4th [Working it out]
Interventions/Control_2
Control group
Normal antenatal education program at clinic or hospital
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
Japanese
Couple who are expected to have a first child
be able to read and write Japanese
Key exclusion criteria
severe psychological illness
poor prognosis in a fetus
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuka NAKAMURA |
Organization
Tohoku University
Division name
Graduate school of Medicine Womens health nirsing
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, sendai, miyagi, JAPAN
TEL
022-171-7957
ynaka@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuka NAKAMURA |
Organization
Tohoku University
Division name
Graduate school of Medicine Womens health nirsing
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, sendai, miyagi, JAPAN
TEL
022-171-7957
Homepage URL
ynaka@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 06 | Month | 02 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 19 | Day |
Last modified on
| 2018 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025279
