UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043125 |
|---|---|
| Receipt number | R000049171 |
| Scientific Title | Hemodynamic changes during labor between epidural and non-epidural analgesia |
| Date of disclosure of the study information | 2021/01/25 |
| Last modified on | 2021/11/30 15:08:56 |
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Basic information
Public title
Hemodynamic changes during labor between epidural and non-epidural analgesia
Acronym
Hemodynamic changes during labor between epidural and non-epidural analgesia
Scientific Title
Hemodynamic changes during labor between epidural and non-epidural analgesia
Scientific Title:Acronym
Hemodynamic changes during labor between epidural and non-epidural analgesia
Region
| Japan |
Condition
Condition
Hemodynamic changes during labor of healthy pregnant women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hemodynamic changes during labor between epidural and non-epidural analgesia
Basic objectives2
Others
Basic objectives -Others
cardiac output
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemodynamic changes during labor between epidural and non-epidural analgesia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
labor epidural analgesia
Interventions/Control_2
non-epidural analgesia delivery
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
ASA1-2
Key exclusion criteria
The person in charge of research judged it to be inappropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Maiko |
| Middle name | |
| Last name | Satomoto |
Organization
Toho University
Division name
Anesthesiology
Zip code
143-8541
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
0337654151
maiko.satomoto@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Satomoto |
Organization
Toho University
Division name
Anesthesiology
Zip code
143-8541
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
0337654151
Homepage URL
maiko.satomoto@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Toho University, Department of Anesthesiology
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
Toho University Ethics Review Board
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
Tel
0337624151
omori.rinri@ext.toho-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
| 2021 | Year | 01 | Month | 25 | 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
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 25 | Day |
Last modified on
| 2021 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049171
