UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052894 |
|---|---|
| Receipt number | R000060288 |
| Scientific Title | Systematic review of antenatal interventions for pregnant woman to make decision on painless delivery |
| Date of disclosure of the study information | 2023/11/24 |
| Last modified on | 2023/11/24 16:38:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Systematic review of antenatal interventions for pregnant woman to make decision on painless delivery
Acronym
Systematic review of antenatal interventions for pregnant woman to make decision on painless delivery
Scientific Title
Systematic review of antenatal interventions for pregnant woman to make decision on painless delivery
Scientific Title:Acronym
Systematic review of antenatal interventions for pregnant woman to make decision on painless delivery
Region
| Japan |
Condition
Condition
Pregnant woman
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identifying the Intervention effectiveness of providing information and decision support to pregnant woman on their choice of painless delivery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Epidural analgesia
Key secondary outcomes
Decisional conflict, Anxiety, Obstetric outcome, Pharmacological pain relief methods, Non-pharmacological pain relief methods
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
A randomized controlled trial comparing decision support to pregnant women regarding their choice of painless delivery versus standard care.
P: Pregnant woman
I: Providing prenatal information, including painless delivery, to pregnant women for decision making.
C: Standard care or counseling, conventional Information pamphlet.
O: Epidural analgesia, Decisional conflict, Anxiety, Obstetric outcome, Pharmacological pain relief methods, Non-pharmacological pain relief methods.
Key exclusion criteria
References written in languages other than English or Japanese.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Toshiko |
| Middle name | |
| Last name | Igarashi |
Organization
Nara Medical University
Division name
Graduate School of Nursing Women's Health and Midwifery
Zip code
634-8521
Address
840 Shijyo-cho, Kashihara, Nara
TEL
0744-22-3051
igarashi@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Kayo |
| Middle name | |
| Last name | Ueda |
Organization
Nara Medical University
Division name
Graduate School of Nursing Women's Health and Midwifery
Zip code
634-8521
Address
840 Shijyo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
k-ueda@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical 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
Nara Medical University Ethics Committee
Address
840 Shijyo-cho, Kashihara, Nara
Tel
0744-22-3051
ino_rinri@naramed-u.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 | 11 | Month | 24 | 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
0
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
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Meta analysis
Management information
Registered date
| 2023 | Year | 11 | Month | 24 | Day |
Last modified on
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060288
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
