UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061154 |
|---|---|
| Receipt number | R000069979 |
| Scientific Title | A Study on the Effectiveness of Digital Tools Supporting Husband-Attended Childbirth to Promote the Transition of Fatherhood Roles in the Post-COVID Era |
| Date of disclosure of the study information | 2026/04/03 |
| Last modified on | 2026/04/03 17:59:34 |
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Basic information
Public title
A Study on the Effectiveness of Digital Tools Supporting Husband-Attended Childbirth to Promote the Transition of Fatherhood Roles in the Post-COVID Era
Acronym
A Study on the Effectiveness of Digital Tools Supporting Husband-Attended Childbirth to Promote the Transition of Fatherhood Roles
Scientific Title
A Study on the Effectiveness of Digital Tools Supporting Husband-Attended Childbirth to Promote the Transition of Fatherhood Roles in the Post-COVID Era
Scientific Title:Acronym
A Study on the Effectiveness of Digital Tools Supporting Husband-Attended Childbirth to Promote the Transition of Fatherhood Roles
Region
| Japan |
Condition
Condition
Healthy maternals and husbands
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of a digital tool supporting husband-attended childbirth in promoting the transition to fatherhood in the post-COVID era.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of Development of an online Delivery with Presence of Husbands system
Key secondary outcomes
<parturient women, > Understanding of delivery progress, self-evaluation scale for childbirth experience
<Husband> Understanding of delivery progress, evaluation of delivery experience, satisfaction with delivery
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Period: Around March 2028 after the approval of the ethical review
Number of times:1 time
Contents: Explanation by delivery animation, questionnaire survey
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
Pregnant women aged 18 or older and their husbands who are scheduled for vaginal delivery at 37 weeks of gestation or later at a single obstetric clinic located in the Hokuriku region.Marital status is not a requirement.
Participants must be able to use a smartphone. Participants must be able to understand Japanese (speaking,reading,and writing).
Key exclusion criteria
Any criteria other than the inclusion criteria.
The questionnaire survey excludes participants whose maternal or neonatal health status was poor between the time of delivery and the time of the request (e. g.,potential for obstetric hemorrhage in the mother, severe complications,or severe complications in the newborn).
Cases where delivery is imminent or participation is difficult due to delivery management considerations,etc.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | AYAKO |
| Middle name | |
| Last name | SASAKI |
Organization
Tsuruga Nursing University
Division name
Faculty of Nursing Science
Zip code
9140814
Address
78-2-1, Kizaki, Fukui, Japan
TEL
0770-20-5500
a-sasaki@tsuruga-nu.ac.jp
Public contact
Name of contact person
| 1st name | AYAKO |
| Middle name | |
| Last name | SASAKI |
Organization
Tsuruga Nursing University
Division name
Faculty of Nursing Science
Zip code
9140814
Address
78-2-1, Kizaki, Fukui, Japan
TEL
0770-20-5500
Homepage URL
a-sasaki@tsuruga-nu.ac.jp
Sponsor or person
Institute
Tsuruga Nursing University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Osaka Medical and Pharmaceutical University
Name of secondary funder(s)
Tsuruga Nursing University
IRB Contact (For public release)
Organization
Tsuruga Nursing University
Address
78-2-1, Kizaki, Fukui, Japan
Tel
0770-20-5500
a-sasaki@tsuruga-nu.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
井元産婦人科医院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2036 | Year | 04 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 03 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069979
