UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044576 |
|---|---|
| Receipt number | R000050797 |
| Scientific Title | Using case studies to support the childbearing families from the fetal stage |
| Date of disclosure of the study information | 2021/06/20 |
| Last modified on | 2022/12/01 15:02:27 |
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Basic information
Public title
Using case studies to support the childbearing families from the fetal stage
Acronym
Using case studies to support the childbearing families from the fetal stage
Scientific Title
Using case studies to support the childbearing families from the fetal stage
Scientific Title:Acronym
Using case studies to support the childbearing families from the fetal stage
Region
| Japan |
Condition
Condition
pregnant women and their partners
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the feasibility of a case study in which couples expecting their first child have the opportunity to discuss family information and social networks related to child rearing at home during pregnancy, and the short-term effects on family stress coping skills, marital satisfaction, and paternal attachment to the fetus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Family stress coping skills
Feasibility evaluation through semi-structured interview
Key secondary outcomes
Marital satisfaction
Paternal attachment to the fetus
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
| Behavior,custom |
Interventions/Control_1
Subjects will be provided with brochures and videos of case studies with opportunities to discuss family information, social networks, etc. related to child care.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
First-time pregnant women and their partners at 22-28 weeks gestation
Key exclusion criteria
1) Couples who plan to live separately for more than 2 months after childbirth due to homecoming delivery to other prefectures.
2) Multiple births or congenital diseases of the fetus
3) If one of the couple has a history of receiving psychosomatic medicine.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Akemi |
| Middle name | |
| Last name | Yamazaki |
Organization
Osaka University
Division name
Graduate School of Medicine, Division of Health Sciences
Zip code
565-0871
Address
1-7 Yamadaoka, Suita, Osaka 565-0871 JAPAN
TEL
06-6879-2530
akemiyamazaki@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Akemi |
| Middle name | |
| Last name | Yamazaki |
Organization
Osaka University
Division name
Graduate School of Medicine, Division of Health Sciences
Zip code
565-0871
Address
1-7 Yamadaoka, Suita, Osaka 565-0871 JAPAN
TEL
06-6879-2530
Homepage URL
akemiyamazaki@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
The Nihonseimei foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2, Yamadaoka, Suita, Osaka 565-0871 JAPAN
Tel
06-6210-8296
rinri@h@-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
| 2021 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
http://nihonseimei-zaidan.or.jp/jidou2/03.html
Number of participants that the trial has enrolled
26
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 05 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 11 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 17 | Day |
Last modified on
| 2022 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050797
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
