UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046420 |
|---|---|
| Receipt number | R000052328 |
| Scientific Title | Effect of a decision aid for birth place: A Randomized Controlled Trial for decision conflict |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2022/10/07 19:18:18 |
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Basic information
Public title
Effect of a decision aid for birth place: A Randomized Controlled Trial for decision conflict
Acronym
Effect of a decision aid for birth place: A Randomized Controlled Trial for decision conflict
Scientific Title
Effect of a decision aid for birth place: A Randomized Controlled Trial for decision conflict
Scientific Title:Acronym
Effect of a decision aid for birth place: A Randomized Controlled Trial for decision conflict
Region
| Japan |
Condition
Condition
Healthy women
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of a web-based decision aids for birth place in a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Conflicts in the decision to choose the place of birth
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
| Other |
Interventions/Control_1
Effect of a decision aid for birth place
Interventions/Control_2
Usual information about birth and place of birth
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
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
Women who have had a vaginal birth.
Married women who wish to become pregnant in the future.
Women who live in Tokyo, Kanagawa, Chiba, Saitama, Osaka, and Hyogo prefectures.
Key exclusion criteria
Women who cannot understand, read and write Japanese.
Women who do not have access to the internet.
Medical professionals: midwives and nurses with history of perinatal work.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Sachiko |
| Middle name | Nitta |
| Last name | Nitta |
Organization
University of Nagasaki
Division name
Faculty of Nursing and Nutrition
Zip code
851-2195
Address
Manabino1-1-1, Nagayo-cho, Nishisonogi-gun, Nagasaki
TEL
095-813-5470
n-sachiko@sun.ac.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Nitta |
Organization
University of Nagasaki
Division name
Faculty of Nursing and Nutrition
Zip code
851-2195
Address
Manabino1-1-1, Nagayo-cho, Nishisonogi-gun, Nagasaki
TEL
095-813-5470
Homepage URL
n-sachiko@sun.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
Ministray of education, culture, sports, science and technology-Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Luke's International University
Address
10-1 Akashicho Chuoku Tokyo, 104-0044 Japan
Tel
03-3543-6391
kenkyukikaku@luke.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 | 12 | Month | 31 | 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
476
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
| 2021 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 20 | Day |
Last modified on
| 2022 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052328
