UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055460 |
|---|---|
| Receipt number | R000063174 |
| Scientific Title | A scoping review of the effectiveness of education, information and decision support during pregnancy regarding epidural analgesia for labour |
| Date of disclosure of the study information | 2024/09/09 |
| Last modified on | 2024/09/09 14:53:19 |
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Basic information
Public title
A scoping review of the effectiveness of education, information and decision support during pregnancy regarding epidural analgesia for labour
Acronym
A scoping review of the effectiveness of education, information and decision support during pregnancy regarding epidural analgesia for labour
Scientific Title
A scoping review of the effectiveness of education, information and decision support during pregnancy regarding epidural analgesia for labour
Scientific Title:Acronym
A scoping review of the effectiveness of education, information and decision support during pregnancy regarding epidural analgesia for labour
Region
| Japan |
Condition
Condition
Pregnant women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find out what we know about decision aids and their effects for women considering choosing epidural analgesia for labour.
Basic objectives2
Others
Basic objectives -Others
To clarify what methods are being used as decision support, when is the most effective time to use them, what are the effective methods, who is an effective implementer, and what is the effect of decision support.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction, anxiety, knowledge, whether epidural anesthesia was received, fear, conflict, birth experience
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) It is not a literature review.
2) The subjects are pregnant women considering the choice of epidural anesthesia, regardless of the number of pregnancies or whether they are planning natural or induced childbirth.
3) Prenatal intervention is provided regarding decision support for epidural anesthesia delivery.
4) There is a comparison subject, such as usual care or no decision support.
5) It is an original paper.
6) It is an English/Japanese paper.
7) It is not a research plan.
Key exclusion criteria
1) It is a literature review.
2) It does not target pregnant women considering the option of epidural anesthesia, regardless of the number of pregnancies or whether natural or induced childbirth is desired.
3) There is no prenatal intervention regarding decision support for epidural anesthesia delivery.
4) There is no comparison subject, such as usual care or no decision support.
5) It is not an original paper.
6) It is not an English/Japanese paper.
7) It is a research plan.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yaya |
| Middle name | |
| Last name | Kishimoto |
Organization
Nara Medical University
Division name
Graduate School of Nursing
Zip code
634-0813
Address
840 Shijocho, Kashihara City, Nara Prefecture
TEL
0744-22-3051
k122757@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | yaya |
| Middle name | |
| Last name | Kishimoto |
Organization
Nara Medical University
Division name
Graduate School of Nursing
Zip code
634-0813
Address
840 Shijocho, Kashihara City, Nara Prefecture
TEL
0744-22-3051
Homepage URL
k122757@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
N/A
Address
N/A
Tel
N/A
N/A
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
| 2024 | Year | 09 | Month | 09 | 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
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A literature search will be conducted using PubMed, CHNAHL, and Medical Journal Web Edition. The search will be supervised by a health science information specialist with experience in literature searches. Search terms will be set in each database using the keywords "anesthesia delivery," "decision-making," and "pregnant women," and a comprehensive study will be conducted targeting Japanese and English literature. Related literature will also be added through hand searches.
Management information
Registered date
| 2024 | Year | 09 | Month | 09 | Day |
Last modified on
| 2024 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063174
