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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021980
Receipt No. 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

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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
Obsterics 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
Email 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
Email ynaka@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025279

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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