UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053355 |
|---|---|
| Receipt number | R000060899 |
| Scientific Title | Development of an online prenatal coparenting program for new parents and evaluation of changes; A feasibility study. |
| Date of disclosure of the study information | 2024/01/15 |
| Last modified on | 2024/07/16 09:15:43 |
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Basic information
Public title
Development of an online prenatal coparenting program for new parents and evaluation of changes; A feasibility study.
Acronym
Development of an online prenatal coparenting program for new parents and evaluation of changes; A feasibility study.
Scientific Title
Development of an online prenatal coparenting program for new parents and evaluation of changes; A feasibility study.
Scientific Title:Acronym
Development of an online prenatal coparenting program for new parents and evaluation of changes; A feasibility study.
Region
| Japan |
Condition
Condition
Pregnancy
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an online programme to promote prenatal co-parenting for new parents and to identify changes in prenatal co-parenting, attachment to the foetus, relationship perceptions and communication between couples, preparations to work together and parenting readiness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Prenatal coparenting
Key secondary outcomes
Attachment to the foetus,Couple relationships perception,Communication between couples, Preparations to parenting together,Parenting readiness.
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
Participate an online prenatal coparenting program.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Couples whom gestational age must be 24-33weeks, both parents must be first-time parents, both parents must be able to participate in this study, .the pregnant woman and foetus must be free from complications that may be life-threatening to the life expectancy,they can access to the internet.
Key exclusion criteria
Couples, including pregnant women whose mental illness is interfering with their daily life to the extent that they require specialised treatment and care.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | NATSUKO |
| Middle name | |
| Last name | KOJIMA |
Organization
Tokyo Healthcare University
Division name
Higashigaoka Faculty of Nursing
Zip code
152-8558
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
0357795031
n-kojima@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Natusko |
| Middle name | |
| Last name | Kojima |
Organization
Tokyo Healthcare University
Division name
Higashigaoka Faculty of Nursing
Zip code
152-8558
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
0357795031
Homepage URL
n-kojima@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Healthcare University
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
Tokyo Healthcare University
Address
4-1-17 Higashigotanda, Shinagawa-ku, Tokyo
Tel
0354217685
kenkyo@thcu.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
| 2024 | Year | 01 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 01 | Month | 15 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060899
