UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047947 |
|---|---|
| Receipt number | R000054662 |
| Scientific Title | Leading to a satisfying delivery experience for mothers and husbands in the COVID-19 |
| Date of disclosure of the study information | 2022/06/04 |
| Last modified on | 2022/06/04 15:17:55 |
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Basic information
Public title
Leading to a satisfying delivery experience for mothers and husbands in the COVID-19
Acronym
Development of an online Delivery with Presence of Husbands system
Scientific Title
Leading to a satisfying delivery experience for mothers and husbands in the COVID-19
Scientific Title:Acronym
Development of an online Delivery with Presence of Husbands system
Region
| Japan |
Condition
Condition
Healthy maternals and husbands
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is Leading to a satisfying delivery experience for mothers and husbands in the COVID-19
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
Self control
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
eriod:Around September 2022 after the approval of the ethical review
Number of times:1time
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.A non-high-risk maternity woman or husband aged 20 or over who is scheduled to have a vaginal delivery after 37 weeks of pregnancy at the Imoto Obstetrics and Gynecology Clinic.
2.You are using a personal computer environment (Microsoft Windows)and a video call environment(either Line,FaceTime,or Zoom) using a smartphone
Key exclusion criteria
Under the age of 20
High-risk pregnancy
High-risk birth
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | AYAKO |
| Middle name | |
| Last name | SASAKI |
Organization
Osaka Medical and Pharmaceutical University
Division name
The Faculty of Nursing
Zip code
5690071
Address
7-6 Hattyonishi-machi, Takatsuki, Osaka 569-0095, Japan
TEL
072-684-7033
ayako.sasaki@ompu.ac.jp
Public contact
Name of contact person
| 1st name | AYAKO |
| Middle name | |
| Last name | SASAKI |
Organization
Osaka Medical and Pharmaceutical University
Division name
The Faculty of Nursing
Zip code
5690071
Address
Hattyonishi-machi, Takatsuki, Osaka 569-0095, Japan
TEL
072-684-7033
Homepage URL
ayako.sasaki@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
The Faculty of Nursing
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University
Address
2-7 Daigaku-machi Takatsuki-city
Tel
072-683-1221
rinri@ompu.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
| 2022 | Year | 06 | Month | 04 | 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
| 2022 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 06 | Month | 04 | Day |
Last modified on
| 2022 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054662
