UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047570 |
|---|---|
| Receipt number | R000054248 |
| Scientific Title | Investigation of factors influencing the choice of labor epidural analgesia. |
| Date of disclosure of the study information | 2022/04/26 |
| Last modified on | 2025/04/02 22:15:54 |
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Basic information
Public title
Factors Influencing the Choice of labor analgesia
Acronym
Factors Influencing the Choice of labor analgesia
Scientific Title
Investigation of factors influencing the choice of labor epidural analgesia.
Scientific Title:Acronym
Investigation of factors influencing the choice of labor epidural analgesia.
Region
| Japan |
Condition
Condition
Pregnancy
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the reasons for choosing epidural labor analgesia, reasons for not choosing it, and social background. Based on the results, we will discuss ways to provide pregnant women with necessary, sufficient, and correct information about labor analgesia.
Basic objectives2
Others
Basic objectives -Others
Based on the results, we will discuss ways to provide pregnant women with necessary, sufficient, and correct information about labor analgesia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reasons for choosing or not choosing labor analgesia
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women who are in term of gestation (>37w) and are scheduled to have a vaginal delivery in our hospital.
Key exclusion criteria
(1) Mental retardation
(2) Those who cannot speak Japanese
(3) Emergency hospitalization for vaginal delivery
(4) Pregnant women under 18 years old
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Okutomi |
Organization
Kitasato university
Division name
School of medicine, department of anesthesiology
Zip code
2520375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa
TEL
0427788111
tokutomi@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Hyuga |
Organization
Kitasato university
Division name
School of medicine, department of anesthesiology
Zip code
2520375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa
TEL
0427788111
Homepage URL
shyuga@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato university
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kitasato university medical ethics organization
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa
Tel
0427788273
rinri@med.kitasato-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
| 2022 | Year | 04 | Month | 26 | 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
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Age and whether the patient is a primiparous or a periparous woman will be surveyed from the patient's chart. The prenatal questionnaire is administered the day before the induction of delivery (the day of admission). The postpartum questionnaire will be administered by the day after delivery.
Evaluation points
Reasons for choosing or not choosing labor analgesia, age, place of birth, educational background, family member, number of
pregnancies and deliveries, sources of information when considering labor analgesia, information when considering it, knowledge about it, knowledge of childbirth, satisfaction with childbirth, factors affecting satisfaction with childbirth, reasons for changing to labor analgesia, improvements to improve satisfaction with analgesia method
Management information
Registered date
| 2022 | Year | 04 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054248
