UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063032 |
|---|---|
| Receipt number | R000072157 |
| Scientific Title | A Morphological Study of the Spine in Pregnant Women in the Third Trimester Using CT Images: A Retrospective Study Comparing Images from the Same Patients During Pregnancy and Non-pregnancy |
| Date of disclosure of the study information | 2026/09/28 |
| Last modified on | 2026/09/23 21:39:22 |
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Basic information
Public title
A Morphological Study of the Spine in Pregnant Women in the Third Trimester Using CT Images: A Retrospective Study Comparing Images from the Same Patients During Pregnancy and Non-pregnancy
Acronym
A Morphological Study of the Spine in Pregnant Women in the Third Trimester Using CT Images: A Retrospective Study Comparing Images from the Same Patients During Pregnancy and Non-pregnancy
Scientific Title
A Morphological Study of the Spine in Pregnant Women in the Third Trimester Using CT Images: A Retrospective Study Comparing Images from the Same Patients During Pregnancy and Non-pregnancy
Scientific Title:Acronym
A Retrospective Study Comparing CT Scans in Pregnant Women with Those in Non-Pregnant Women
Region
| Japan |
Condition
Condition
Pregnant Women
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Not applicable |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will compare CT images of pregnant patients taken during the third trimester with those taken when they were not pregnant, and examine and identify the morphological characteristics of the spine in women during the third trimester. Furthermore, using the results of this morphological analysis, we will investigate the puncture sites and techniques that are likely to yield a high success rate when performing spinal anesthesia on women in the third trimester.
Basic objectives2
Others
Basic objectives -Others
We will examine differences in the morphological characteristics of the spine between pregnancy and non-pregnancy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2D CT Image Data Parameters (1. Lumbar lordosis angle, 2. Sacral tilt angle, 3. Pelvic tilt angle, 4. Length of the ligamentum flavum, 5. Distance between the skin and the epidural space, 6. Distance between the skin and the subarachnoid space of the spinal cord, 7. Range of angles suitable for puncture)
Key secondary outcomes
CT Image 3D Data Items
Using 3D-reconstructed data, we analytically determine puncture points on the skin that allow access to the subarachnoid space of the spinal cord, and calculate and analyze the area of the puncture-accessible region.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Patients who underwent a CT scan at this hospital during pregnancy at 28 weeks or later, with the imaging range covering the lumbar spine through the pelvis
2. Patients who underwent a CT scan during a non-pregnancy period (excluding the 9-week period following delivery), with the imaging range covering the lumbar spine through the pelvis
Key exclusion criteria
1. Patients with a history of spinal surgery or spinal lesions
2. Any other individuals whom the principal investigator deems unsuitable as study subjects (participants)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | KUNIHIRO |
| Middle name | |
| Last name | MITSUZAWA |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi Matsumoto, Nagano
TEL
0263372670
mitsukuni@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | KUNIHIRO |
| Middle name | |
| Last name | MITSUZAWA |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi Matsumoto, Nagano
TEL
0263372670
Homepage URL
mitsukuni@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
None
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
Shinshu University School of Medicine Biological and Medical Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto City, Nagano
Tel
0263-37-3099
mdrinri@shinshu-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
| 2026 | Year | 09 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will extract from the electronic medical records patients who underwent CT scans covering the lumbar spine and pelvis during the third trimester (28 weeks or later) and during non-pregnancy, and identify the morphological characteristics of the spine in third-trimester pregnant women by comparing spinal morphology between the third trimester and non-pregnancy. Based on the extracted morphological characteristics, we will investigate the puncture sites and techniques that are likely to result in a high success rate for epidural anesthesia in pregnant women during the third trimester.
Management information
Registered date
| 2026 | Year | 09 | Month | 23 | Day |
Last modified on
| 2026 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072157
