UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050038 |
|---|---|
| Receipt number | R000057003 |
| Scientific Title | Questionnaire survey |
| Date of disclosure of the study information | 2023/01/14 |
| Last modified on | 2023/01/14 12:00:05 |
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Basic information
Public title
Investigation of the actual situation of obstetrician-gynecologists and midwives who assisted in childbirth and the necessity of the technique
Acronym
Questionnaire Survey on Childbirth Assistance Techniques
Scientific Title
Questionnaire survey
Scientific Title:Acronym
Questionnaire survey
Region
| Japan |
Condition
Condition
delivery
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study clarifies the recognition of the need for labor assistance techniques and procedures performed by obstetrician-gynecologists and midwives who assisted in labor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of procedures during delivery assistance
Necessity level for performing procedures when assisting delivery
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 23 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Doctors/midwives with experience in childbirth assistance
Key exclusion criteria
N/A
Target sample size
412
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Kanazawa |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
0298533985
ykanazawa@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kanazawa |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
0298533985
Homepage URL
ykanazawa@md.tsukuba.ac.jp
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
others
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
The Ethics Committee of the Faculty of Medicine, University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
Tel
0298533022
sien.ningenss@un.tsukuba.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
| 2023 | Year | 01 | Month | 14 | 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
200
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will ask all 328 delivery facilities and 332 midwifery facilities to cooperate with the research.
Request distribution to each facility.
The collection will be posted by the research collaborators in a mailbox.
The questionnaire is an anonymous self-administered questionnaire.
The questionnaire items consist of 50 items created independently.
Management information
Registered date
| 2023 | Year | 01 | Month | 14 | Day |
Last modified on
| 2023 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057003
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
