UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031273 |
|---|---|
| Receipt number | R000013593 |
| Scientific Title | The study of inferior vena cava compression by pregnant uterus on venous return and epidural plexus |
| Date of disclosure of the study information | 2018/02/14 |
| Last modified on | 2022/09/05 16:05:31 |
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Basic information
Public title
The study of inferior vena cava compression by pregnant uterus on venous return and epidural plexus
Acronym
Effect of lateral tilt angle on inferior vena cava compression in pregnant women
Scientific Title
The study of inferior vena cava compression by pregnant uterus on venous return and epidural plexus
Scientific Title:Acronym
Effect of lateral tilt angle on inferior vena cava compression in pregnant women
Region
| Japan |
Condition
Condition
pregnant woman
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although the left-lateral tilt position following spinal anesthesia is often promoted to reduce compression of the inferior vena by the pregnant uterus, the assumption that this position leads to decreased compression of the inferior vena has not been validated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in volume of inferior vena cava and aorta
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
MRI measurement
Interventions/Control_2
Tilting position
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
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
Female
Key exclusion criteria
male
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ozaki |
Organization
Tokyo Woman Medical University
Division name
Department of Anesthesiology
Zip code
1628666
Address
8-1 Kawadacho, Shinjuku
TEL
03-3353-8111
ozaki.makoto@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Higuchi |
Organization
Tokyo Woman Medical University
Division name
Department of Anesthesiology
Zip code
1620866
Address
8-1 Kawadacho, Shinjuku
TEL
03-3353-8111
Homepage URL
hhiguchi@twmu.ac.jp
Sponsor or person
Institute
Tokyo Woman Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Woman Medical University
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
Tokyo Woman Medical University
Address
8-1 Kawadacho, Shinjuku, Tokyo
Tel
03-3353-8111
hhiguchi@twmu.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
| 2018 | Year | 02 | Month | 14 | 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
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 13 | Day |
Last modified on
| 2022 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013593
