UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045293 |
|---|---|
| Receipt number | R000051717 |
| Scientific Title | Anesthesia management of pregnant women with spinal diseases: case series |
| Date of disclosure of the study information | 2021/08/28 |
| Last modified on | 2023/09/29 12:39:27 |
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Basic information
Public title
Anesthesia management of pregnant women with spinal diseases: case series
Acronym
Anesthesia management of pregnant women with spinal diseases: case series
Scientific Title
Anesthesia management of pregnant women with spinal diseases: case series
Scientific Title:Acronym
Anesthesia management of pregnant women with spinal diseases: case series
Region
| Japan |
Condition
Condition
Pregnant women with spinal diseases
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the success rate of anesthesia in pregnant patients with spinal diseases at Juntendo University Nerima Hospital.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Successful rate of neuraxial anesthesia, the incidence of catheter placement difficulty, and postpartum pain score on numeric rating scale.
Key secondary outcomes
Existence of neurological complications after anesthesia
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
| 20 | years-old | <= |
Age-upper limit
| 46 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Ages between 20 and 46 at the time of consent acquisition.
2. Patients who self-reported spinal disease.
Key exclusion criteria
None.
Target sample size
847
Research contact person
Name of lead principal investigator
| 1st name | Kikuchi |
| Middle name | |
| Last name | Toshihiro |
Organization
Juntendo University Nerima Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
177-8521
Address
3-1-10 Takanodai, Nerima-ku, Tokyo
TEL
03-5923-3111
toshi.kikuchi@juntendo-nerima.jp
Public contact
Name of contact person
| 1st name | Okada |
| Middle name | |
| Last name | Hisako |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
279-0021
Address
2-1-1 Tomioka, Urayasu-shi, Chiba
TEL
047-353-3111
Homepage URL
h-okada@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Nerima Hospital
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
Juntendo Nerima Hospital GCP center
Address
3-1-10 Takanodai, Nerima-ku, Tokyo
Tel
03-5923-3111
gcp@juntendo-nerima.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
順天堂大学医学部附属練馬病院 Juntendo University Nerima Hospital
麻酔・ペインクリニック Department of Anesthesiology and Pain Medicine
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37644259/
Number of participants that the trial has enrolled
847
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 08 | Month | 30 | Day |
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 | 06 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 28 | 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
The subject`s diagnosis, name, age, gender, physical findings, and test results (blood test, imaging test) are measured.
Case-series study
Management information
Registered date
| 2021 | Year | 08 | Month | 28 | Day |
Last modified on
| 2023 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051717
