UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049043 |
|---|---|
| Receipt number | R000055871 |
| Scientific Title | Quality improvement of shared decision making support of the use of epidural anesthesia during labor for pregnant women and midwives |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2023/03/29 18:45:48 |
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Basic information
Public title
Decision support for the use of epidural anesthesia during labor
Acronym
Decision support for the use of epidural anesthesia during labor
Scientific Title
Quality improvement of shared decision making support of the use of epidural anesthesia during labor for pregnant women and midwives
Scientific Title:Acronym
Quality improvement of shared decision making support of the use of epidural anesthesia during labor for pregnant women and midwives
Region
| Japan |
Condition
Condition
pregnant women
midwife
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improving the quality of shared decision support between pregnant women and health care providers regarding the use of epidural anesthesia during labor and health care providers regarding the use of epidural anesthesia during labor
Basic objectives2
Others
Basic objectives -Others
Implementation Science
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decision-making conflicts
Key secondary outcomes
1.Pregnant women
1) Knowledge of epidural anesthesia delivery
2) Percentage of women who received the desired method of birth pain relief
3) Mothers' satisfaction with their childbirth experience
2. Midwives (Implementation Outcomes)
1) Reach
2) Fidelity
3) Feasibility
4) Acceptability
5) Appropriateness
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
| Other |
Interventions/Control_1
Shared Decision-Making Program for Epidural Anesthesia Delivery
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1Pregnant women who are unsure about the use of epidural anesthesia during delivery and have not yet made a decision to use epidural anesthesia.
2Pregnant women who have received a full explanation of their participation in this study, and who have given written consent of their own free will based on full understanding.
3 Advanced midwives
4Midwives involved in painless labor and delivery care
5 Midwives who have received full explanation of their participation in this study, and who have obtained written consent of their own free will based on full understanding.
Patients who meet all of the above criteria 1 to 2 and midwives who meet all of the above criteria 3 to 5 will be included in the study.
Key exclusion criteria
1Pregnant women who wish to have a natural birth
2Pregnant women scheduled for cesarean section
3Pregnant women who are scheduled to have a medically indicated painless delivery
4Other patients deemed inappropriate as research subjects by the principal investigator
5Midwives who are not certified as advanced midwives
6 Midwives who are not involved in the care of painless delivery
Midwives who are not certified as advanced midwives
7Other midwives whom the principal investigator judges to be inappropriate as research subjects
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | UCHIDA |
Organization
St Luke's international University
Division name
Graduate School of Nursing Science Doctor of Nursing Practice
Zip code
1040044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
TEL
03-3543-6391
19dn102@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | UCHIDA |
Organization
St Luke's international University
Division name
Graduate School of Nursing Science Doctor of Nursing Practice
Zip code
1040044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
TEL
03-3543-6391
Homepage URL
19dn102@slcn.ac.jp
Sponsor or person
Institute
St Luke's international University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
Graduate School of Nursing Science Doctor of Nursing Practice
Tel
03-3543-6391
19dn102@slcn.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
東京女子医科大学病院(東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 01 | 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
22
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 | 03 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | 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 | 09 | Month | 27 | Day |
Last modified on
| 2023 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055871
